Lediga jobb som Farmakologer och biomedicinare i Mölndal

NGS Molecular Biologist - Oligonucleotide therapies
Are you an experienced scientist with great expertise in Next Generation Sequencing and Molecular Biology? Do you want to use this expertise to contribute to the discovery of novel oligonucleotide therapies? We have an opening suitable for you
This is initially a 1 year long contract with KellyOCG, but you will be fully integrated with AstraZeneca, where you will be integrated to your team and have your manager. After a completed contract there is a possibility for an extension, or other oppurtinites - such as a transfer to AstraZeneca full time.
Right now, AstraZeneca are looking for a passionate and hard-working Molecular Biologist with NGS skills to join our NGS & Transcriptomics function within the Centre of Genomic Research Department at AstraZeneca in Gothenburg, as one of our group members is going on parental leave. You will contribute with your expertise in applying molecular biology and NGS to the discovery of novel oligonucleotide therapies.
AstraZeneca’s ambition is to become world-leading in in the field of oligonucleotide therapies. We are achieving this through advances in oligonucleotide science and innovation internally and through the establishment of key collaborations outside AstraZeneca. To this end, we currently have a portfolio of very high-profile projects at different phases of drug discovery within AstraZeneca, and you will directly contribute to their successful progression to oligonucleotide therapies.
What you will do:
This lab-based role is for a Molecular Biologist with significant NGS expertise, which you will apply to the characterization and profiling of the effects of oligonucleotide treatments in in vitro and in vivo cellular assays and models in support of novel drug discovery projects.
Our team is a collaborative group, and you will engage in the supervision and mentorship of other scientists, ensuring that methods run expertly and accurately, developing and guiding the setup of new techniques. Included in the role is also to nurture strong collaborative relationships with the project investigators, key partners, and data scientists to ensure the smooth running of projects.


Requirements:
• Ph.D. degree or MSc with corresponding experience in a relevant scientific discipline.
• Hands-on lab-based experience in utilizing advanced molecular biology RNA-sequencing techniques.
• Experience covering all relevant aspects from hypothesis generation, through experimental design and execution, large-scale RNA and DNA extraction, sample and library preparation, sequencing, data handling, post-sequencing QC, and troubleshooting.
• Experience in the detection of nucleic acids in high-throughput assays and approaches.
Desirable
• Working with laboratory automation / liquid handling systems, method and technology development and optimization.
• Knowledge of Oligonucleotide therapies (siRNAs and/or ASO)
• Hands-on laboratory experience running NGS platforms (Illumina, Oxford Nanopore etc).
• Sample Tracking by LIMS systems.


Interested?
The last day to send in your application is September 4th. We will continuously reach out to candidates for this position, and may close down the ad earlier. Visa mindre

Do you have a scientific or clinical background combined with an entrepreneurial attitude and business know-how? Would you like to apply your expertise in a company where we are following the science and turn ideas into life changing medicines? Then you might be the one we are looking for!
Join the Search and Evaluation Department within Business Development and Licensing, Biopharmaceutical R&D with focus on CVRM in Gothenburg, Sweden.

Job description
The Search and Evaluation Director, Cardiovascular, Renal and Metabolism, in Business Development and Licensing is a key role in Biopharmaceuticals R&D, AstraZeneca.
You will support global Business Development initiatives and have a direct impact on the scientific strategy and portfolio.
The Search and Evaluation (S&E) group drives search efforts of external innovation throughout the Biopharma R&D community and conducts technical due diligence activities that ensure an in-depth understanding of investment opportunities and provides decision-making tools for the organization.

Who are you?
You have a strong R&D scientific and / or clinical background, business acumen and excellent communication skills as well as an ability to engage and collaborate across boundaries with an entrepreneurial attitude and delivery focus.

Major Duties and Responsibilities:
Reporting to the Head of S&E, CVRM, you will be responsible for identifying and evaluating external in-licensing opportunities from academia, biotech’s and peer-pharma including early research projects, new modality platforms, early and late clinical stage candidates and Life Cycle Management (LCM) opportunities
You will be responsible for representing the Business Development strategy at partnering meetings to identify exernal assets and opportunities.
You will integrate input from various functional areas across the organization to create high quality, clear and concise confidential evaluation reports of external assets and will provide recommendations to Head of S&E.
You will identify and evaluate key strategic collaborations and technical platform capabilities that can enhance the scientific credibility and portfolio of Biopharmaceuticals R&D CVRM.
You will works constructively with key stakeholders and cross-functional teams including commercial to ensure effective communication, efficient decision-making, to support completion of transactions with BD teams in a timely manner
You will track breakthrough innovation, ongoing clinical trials and market trends of existing external CVRM opportunities using competitive intelligence tools to identify opportunities, threats and risks in a timely manner.

Culture:
A dynamic, entrepreneurial and externally facing organization which enables an internally and externally collaborative culture with calculated risk taking.
Collaborate closely with colleagues in CVRM and BD teams, and across business to identify and exploit cross-business opportunities and embed best practice.



Education:
Advanced Degree Required (MD or PhD or PharmD).



Requirements and Qualifications:
Strong scientific reputation in drug discovery and clinical development
Basic understanding of deal making
Ability to interact and communicate effectively
Proven leadership abilities in a R & D environment
A strong understanding of clinical development experience in CVRM , demonstrating cultural sensitivity and awareness.
Extensive experience in pharmaceutical R&D, demonstrating international experience in multiple cultures and R & D environments.
Ability to think critically, creatively and to anticipate and solve problems
Ability to navigate and be successful in a fast-paced, highly-matrixed work environment



Leadership and Behaviours:
Excellent communicator who take responsibility for decisions made. Role model engagement and commitment.
Able to lead culture shift and raise the bar in performance at all levels in the organization
Able and accountable for driving business performance.
Understand the wider AstraZeneca business priorities
Appreciate that scientific expertise needs to be balanced with business leadership
Able to actively seek collaboration in a complex matrix structure



Apply with your CV and Cover letter no later than May 21st, 2025 Visa mindre

Heres a chance to join our dynamic team at Ribocure Pharmaceuticals AB as an SML, where you will contribute in Ribocures mission to build a world-leading RNA therapeutics R&D company in Sweden and help patients all over the world. We are dedicated to developing innovative treatments that make a difference in patients' lives. At Ribocure, we foster a culture of excellence and are committed to the highest standards of quality in everything we do.
We are now searching fora highly motivated colleague to join our Clinical Sample Management Team.
About the Job
As ourSample Management Lead you will playa coordinating role in a cross-functional setting. The responsibilities cover the entire life cycle of our clinical samples, from protocol development to sample analysis and destruction, including laboratory vendor selection and contracting.
The career level will be adjusted based on the candidate's experience, allowing for flexibility in responsibilities and expectations
Key Responsibilities of the Position1. Laboratory Vendor Selection and Contract Management Lead the identification, selection, and contracting of appropriate laboratories for Pharmacokinetic- (PK), Pharmacodynamic- (PD) and Anti-Drug Antibodies (ADA) analysis.
Collaborate closely with the Clinical Operations Trial Lead and cross-functional experts from various departments like Bioanalysis, Pharmacology, Medical, Translational Science and Clinical Pharmacology to ensure that selected laboratories and assays meet scientific and regulatory requirements.
2. Contribute to Clinical Trial Protocol development and support Regulatory and Ethical Committee submissions Ensure sample collection time points are cost efficient and patient/site centric in regards of blood volumes collected and operational aspects from a site perspective.
Review of trial participant information and the Informed Consent Form.
Responsible for Biobank applications, when applicable.
3. Clinical Sample Management and Lab Kit Supply Coordination Ensure accurate lab kit development and site supply, as well as lab manual development/review.
Training of site staff and CRAs at Site Initiation Visits and continuous support throughout the trial.
Responsible for clinical trial-level sample management, ensuring that samples are delivered from the right patients to the laboratory at the right time.
Ensure Data Transfer Agreements are in place.
4. Data Tracking Oversight and Issue Resolution Coordination Work closely with Clinical Operations, Clinical Pharmacology/Modeling, Medical and selected vendors to ensure critical data is available, analyzed and transferred in a timely manner.
First point of contact and coordinating troubleshooting of PK, ADA and PD sample analysis and assay issues, and proactively anticipating and mitigating potential problems.
5. Communication and Process Improvement Proactively communicate updates and timelines to stakeholders, provide advice and guidance on the sample management process
Collaborate with preferred vendors and quality assurance personnel to develop improvements in the sample management process.
6. Biobank Support the Ribocure Biobank manager in biobank related activities, such as handling of clinical samples, drafting Material Transfer Agreements and assisting in the annual quality control.
Essential Requirements
You must live in the proximity of Gothenburg, Sweden, to be qualified for this position.
University degree, preferably in pharmaceutical sciences, pharmacology, biomedical engineering, biochemistry, biological science, or discipline associated with medicine or clinical research
Minimum of 3 years’ experience in the pharmaceutical or biotech industry
Hands on experience and/or technical knowledge related to different methods and assays used for analyzing PK, ADA, PD and biomarkers (particularly different ELISA techniques, MSD and LC-MS)
Strong competence in English communication, both in writing and speaking
Ability to work independently as well as in a cross-functional setting
Proven ability to coordinate effectively and manage multiple tasks simultaneously in a fast-paced and dynamic work environment
Desirable Requirements Experience of working in a global context where you appreciate and understandcultural differences
Experience in clinical development, working with clinical trials and central lab activities as a sponsor, CRO, or at the site level
Experience of setting up bioanalytical and/or PD assays and related trouble shooting
Experience in biobanking, including handling regulatory requirements, compliance, and operational processes


Our offerWe offer a competitive salary, comprehensive benefits package, and opportunities for growth and advancement. The career level will be adjusted based on the candidate's experience, allowing for flexibility in responsibilities and expectations. We are an equal opportunity employer and welcome applicants from all backgrounds.
We invite you to joinour fast-expanding global organization towards being one of the leading players in oligonucleotide therapeutics.
If you believe this job would be a good match for you, apply as soon as possible but no later than December 15th, 2024.Kindly note that we will assess candidates on a continuous basis.
You apply easily here using the Send Application button where youwill be able to upload CV and cover letter in the system.
Welcome! Visa mindre

WeQuel is seeking a talented consultant for our client, AstraZeneca
AstraZeneca is a major international healthcare business engaged in the research, development, manufacture, and marketing of prescription pharmaceuticals, as well as the supply of healthcare services. AstraZeneca is proud to offer a unique workplace culture that inspires innovation and collaboration. Co-workers are empowered to express diverse perspectives and are made to feel valued, energized, and rewarded for their ideas and creativity.
Pharmaceutical Sciences at AstraZeneca
Delivering the therapies of the future through scientific leadership in drug delivery, design of synthetic routes, and manufacturing of Active Pharmaceutical Ingredients (API) and Investigational Medicinal Product (IMP) across all AstraZeneca therapy areas. The vision is to be “pharmaceutical science leaders, creating innovative and cost-effective solutions, shaping the diverse therapies of the future.”
Role: Analytical Chemist (Scientist/Senior Scientist)
We’re looking for a talented and motivated Analytical Chemist (Scientist/Senior Scientist) to join the analytical characterization team within Early Product Development and Manufacturing (EPDM) in Gothenburg, Sweden.
This role is located in Gothenburg, Sweden.
What You’ll Do
As a Scientist/Senior Scientist, you will join a highly collaborative team delivering analytical science to drug product development within the early portfolio up to phase II. This is a lab-based role where you will:
Work collaboratively with colleagues and document experiments carefully and to the right quality.
Contribute to regulatory clinical trial applications (CTAs).
Apply your analytical expertise to progress drug product development and contribute to the field of analytical science at AstraZeneca.
Engage and collaborate across boundaries with a positive problem-solving attitude and a focus on delivery.

Essential Requirements
Educational Background:
University degree (MSc, PhD) in a relevant discipline, preferably with industry experience.
Scientific Knowledge:
Expertise in analytical science, particularly chromatography with relevant detection techniques for small molecules.
Broad industry experience in pharmaceutical development, including oral solid dosage forms.
Familiarity with CMC regulatory submissions and GMP-compliant work.
Proficiency in specific analytical techniques for small molecules, e.g., mass spectrometry, NMR, dissolution.
Communication Skills:
Excellent written and oral communication skills in English.
Additional Experience:
Knowledge or interest in automation, AI, and digitalization is advantageous.
A proven track record of publications related to analytical science or pharmaceutical characterization is desirable.

Soft Skills
A driven experimentalist passionate about delivering relevant and reliable data.
Influential in multidisciplinary project teams with a collaborative approach.
Keen on driving scientific development within the analytical science field.
Strong leadership, collaboration, and networking abilities.

Why AstraZeneca?
AstraZeneca is committed to making a difference through a passion for science, integrated with digital innovation. By harnessing data, AI, and the latest technologies, AstraZeneca accelerates research and ensures breakthroughs make a real difference for patients worldwide.
Are you ready to make an impact in a dynamic environment that values science, innovation, and creativity? Apply today! Visa mindre

Job description
Here´s a chance to join our dynamic team at Ribocure Pharmaceuticals AB as a GCP QA. Where you will contribute in Ribocures mission to build a world-leading RNA therapeutics R&D company in Sweden and help patients all over the world. We are dedicated to developing innovative treatments that make a difference in patients' lives. At Ribocure, we foster a culture of excellence and are committed to the highest standards of quality in everything we do.
At Ribocure the spirit is positive and you feel the community amongst co-workers and consideration of each other. In this fast pace environment, everyone is committed to delivering well all the while finding time to have fun and share culture exchanges cross countries as well.
As a GCP QA, you will play a critical role in ensuring the quality and compliance of our clinical development. You will work closely with cross-functional teams, including Clinical Operations, Regulatory Affairs and our own Ribocure Clinic, to uphold the highest standards of quality. You will also collaborate with the QA department within Suzhou Ribo (Parent company of Ribocure). Your responsibilities will include conducting audits, managing CAPAs, and maintaining compliance with regulatory requirements across various GxP areas, with a particular emphasis on GCP, all crucial for supporting Ribocure’s mission and strategic goals.
You will report to the Head of Clinical Operations and QA but will have a dotted line directly to Ribocure's CEO for any escalation needs, ensuring the independence of the QA function. The career level will be adjusted based on the candidate's experience, allowing for flexibility in responsibilities and expectations. Preferably you are based in the Gothenburg area. If you are not, it is a requirement to visit the site continuously.
Join Ribocure and contribute to our mission of delivering high-quality treatments that improve patients’ lives. If you are passionate about quality and have the expertise we are looking for, we encourage you to apply. We will do the selection continuously so please apply at www.randstad.se. If you have questions, please contact Karolina Andersson at [email protected]




For Ribocure and Randstad, it is important that all competence and skills in the labor market are utilized. We welcome all applicants and strive for diversity. 

Responsibilities
You will join a competent and inspiring team and your main responsibilities will be:
Ensure appropriate development, maintenance and continuous improvement of the Quality Management System (QMS)
Support inspection readiness activities and prepare and host inspections from regulatory authorities
Develop the annual audit program in collaboration with the Heads of Clin Ops and Ribocure Clinic
Conduct internal and external audits to assess compliance with GCP (Good Clinical Practice) and other applicable GxP regulatory requirements
Collaborate with cross-functional teams to ensure quality is maintained throughout the product lifecycle
Support Ribocure Clinic staff to ensure quality and compliance at our Ribocure Clinic.
Review and approve quality-related documentation, including policies/SOPs and related documentation, vendor evaluation, validation protocols etc
Manage deviations, CAPAs (Corrective and Preventive Actions), and change controls to ensure timely and effective resolution
Monitor and report on key quality metrics, driving continuous improvement initiatives.
Collaborate with Suzhou Ribo QA department to ensure appropriate alignment, support in quality issues/CAPA assessments, knowledge sharing, joint training sessions etc
Provide training and support to staff on GCP and current regulations, quality assurance procedures and best practices
Stay current with industry trends and regulatory changes to ensure the company's compliance and competitive edge


Qualifications
To thrive and be happy in the role, we see that you bring the following experience and skill-sets:
University degree, preferably in medical or biological science or discipline associated with clinical research
Minimum of 5 years experience in quality assurance within the pharmaceutical or biotech industry
Proven audit experience, including conducting GCP audits and preparing audit reports.
Strong knowledge of regulatory requirements and industry standards (e.g., FDA, EMA, ICH).

It will be seen as a merit if you also are certified in audit training and if you can demonstrate experience and ability to drive process improvement and/or functional work.
As a co-worker you are engaged, analytical, pragmatic and solution oriented. You like collaboration and build relationships in the organization with ease. You also have good communication skills and you are humble and flexible in relation to others.

About the company

Ribocure Pharmaceuticals AB
Ribocure Pharmaceuticals AB is a clinical stage biotech company with a business focus on the development of cutting-edge RNA therapeutics. Ribocure’s primary focus lies in addressing the significant medical gaps in rare diseases involved in the fields of cardiovascular, renal, and oncology. The company is dedicated to the discovery and development of groundbreaking drug assets utilizing advanced oligonucleotide technologies.
Operating as a subsidiary of Ribo Life Science Co., Ltd., Ribocure leverages the advantages of a vertically integrated oligonucleotide research platform and excels in translational and clinical operations. Our comprehensive technological platforms encompass the entire process, from sequence design, screening, and optimization to delivery technologies and large-scale commercial CMC capacity. Visa mindre

Are you a passionate and experienced scientist with expertise in molecular biology and recombinant protein expression? Fuelled by our commitment to help more patients, strengthen our pipeline and grow our area. This might be your next challenge!
We are now looking for a Molecular Biologist to join us as a Research Scientist at AstraZeneca in our Protein Sciences department in Discovery Sciences. This department is based in our vibrant R&D site in Gothenburg, Sweden, and is responsible for the delivery of protein reagents to discovery projects. You will be part of a team of enthusiastic scientists to deliver deep technical and scientific expertise in Molecular Biology. This role is an opportunity to contribute to the development and execution of research strategies for the discovery of new medicines.
What you will do
In this role, you will provide key molecular biology expertise for the design and generation of DNA constructs for downstream drug discovery applications such as recombinant expression of protein reagents, reporter gene assays, cell lines, DNA libraries, and recombinant production of proteins for structure and biophysics. We are seeking a highly skilled and motivated Research Scientist to join our dynamic team. The successful candidate will deliver from the lab with construct design and high throughput construct generation.
Essential for the role
MSc in relevant scientific discipline (e.g. Molecular Biology, Genetics, or Bioinformatics), or a related discipline, with relevant experience, preferably in the pharmaceutical or biotechnology industry.
Extensive experience in high throughput cloning techniques such as Golden Gate and Gibson assembly with strong problem-solving skills.
Demonstrated proficiency with automation equipment and programming (e.g. Python) of liquid handlers (BiomekI7 or equivalent).
Demonstrated expertise in Next Generation Sequencing technology including Illumina and Nanopore sequencing with hands on experience and the ability to configure Bioinformatics pipelines.
Strong communication skills, team working and capable of bridging gaps across disciplines.

Desirable for the role
Experience working in LIMS environment and request management systems, e.g., Benchling, Geneious, demonstrated data management experience and excellent level of compliance.
Proven ability to support IT technology development projects.

Why AstraZeneca?
Always advancing our scientific knowledge and helping to shape the future of healthcare for the greatest and swiftest impact on disease. Thrive in a place where the brightest and most curious minds seamlessly come together in our inclusive environment. We truly believe that everyone contributes with a unique set of competence. Your curiosity and passion for personal development combined with support from colleagues, mentors and leaders, will ensure you maximise your skills, abilities and contribution. Visa mindre

Are you an experienced scientist with expertise in pharmacokinetics, pharmacology and drug metabolism (DMPK)? Would you like to apply your expertise in a global company that follows the science and turn ideas into life changing medicines? Then you could be the new colleague we are looking for!
Our team is growing, and we are now looking for two motivated individuals with experience in Biologics and/or small molecule drug development and PKPD, to join us as a DMPK Project Leader, from candidate selection to registration and beyond. These positions are placed at AstraZeneca’s dynamic R&D site in Gothenburg, Sweden. Working at AstraZeneca means being entrepreneurial, following the science, scrutinizing data and details simultaneously with holistic thinking and through teamwork make progress.
Respiratory & Immunology (R&I) is one of the three main therapeutic research areas within AstraZeneca. Early R&I is a global function, with research units in Gaithersburg (US), Cambridge (UK) and Gothenburg (Sweden), and delivers candidate drugs into clinical development. DMPK interacts with other functions in supporting Early R&I projects all along the value chain, from target selection all the way to market launch and Life cycle management.
What you’ll do?
With a true passion for drug discovery you will support our portfolio within the R&I therapeutic area as a subject matter expert. In the DMPK project lead role you will work collaboratively with project representatives from other disciplines. These may include biology, safety , clinical pharmacology, pharmaceutical sciences, antibody Discovery/Protein Engineering and medicinal chemistry, where your task is to influence candidate profiling by providing the necessary DMPK support for clinical investigations.
It is your responsibility to ensure delivery of all DMPK related activities throughout the value chain in accordance with regulatory requirements. These include preclinical PK experiments, in vitro ADME and biotransformation to yield pharmacokinetic understanding. Furthermore, assisting design of pharmacodynamic studies that ultimately delivers a pharmacological assessment underpinning human dose prediction and emerging clinical experience.
You will work as the development DMPK representative on project teams from candidate selection to registration and beyond. We believe that you have a solid understanding of DMPK, a working knowledge of pharmacology, and that you will be able to provide expert advice and interpretation of complex nonclinical and clinical data.
Main duties and responsibilities;
Communicate scientific progresses both externally and internally
Deliver DMPK input and data to projects within agreed timelines and to the right quality
Responsible for delivering and produce the nonclinical pharmacokinetic documentation to support clinical progression
Apply an understanding of DMPK to support/influence compound profiling, project progression and project strategy
Define and deliver a translational quantitative PKPD strategy in projects, so that effective conclusions can be made
Contribute to estimation of safety margins and report results and interpretations to project teams and internal governance bodies
Responsible for leading, coordinating and engaging with R&I DMPK colleagues in project related activities
Prepare clear presentations related to the above for internal governance bodies

Your level of professional experience will be relevant for your initial career level (Associate Principal Scientist or Principal Scientist).
?Essential for the role
PhD or equivalent experience in a relevant field
Expert in DMPK sciences with profound knowledge of drug discovery and development processes
Broad experience in biologics drug development (PK & Bioanalysis)
Have PK modelling skills, experience of human PK and dose prediction, as well as an understanding of disease biology and PKPD
Experience with regulatory submissions for biologics and/or small molecules
Knowledge of all DMPK assays including the use of in silico tools for PK prediction
Experience in project leadership
Collaborative mindset
Team player
Proactive in providing expert support to project team and excellent communication skills

Why AstraZeneca?
At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and development. Visa mindre

Within Translational Science and Experimental Medicine
Are you a forward-thinking and curious Bioinformatician with skills in large scale omic analysis? Do you also want to improve the way we discover and develop medicines? Welcome to join AstraZeneca!
We are looking for an experienced bioinformatician to join our Data Science & Bioinformatics team. You will be part of the Translational Science and Experimental Medicine (TSEM) department in the Respiratory and Immunology therapeutic area. As a department we promote an open and collaborative atmosphere, with a culture that is both science-based and patient-focused. Our mission is to understand disease mechanisms at the molecular level, identify the most effective targets and the right patient populations.
This role is located at one of our sites in either Gothenburg (Sweden) or Gaithersburg (US).
Be encouraged and supported to think creatively in our dynamic environment. Here we are free from fear of failure, free to ask the right questions and make bold decisions. We harness data science & AI to fast-forward our research. Making sure work born in a lab can make a real difference, every day, impacting patients’ lives across the world.
What you will do?
In this role, you will work in a highly cross-functional and thriving environment together with specialists in sequencing, immunological and respiratory disease, as well as with other data science & bioinformatics experts.
For this role we are looking for an outstanding bioinformatician to enable translational science via integration of large-scale omics, clinical data, real world evidence and literature data to deliver precision medicine within our pipeline. You´ll be identifying novel targets, biomarkers and patient sub-groups through innovative data analysis approaches including utilization of clinical cohort omics data sets.
You will contribute to the identification of transformational precision medicine propositions to deliver life changing medicines to patients. You will be responsible for planning, performing and interpreting your analysis and communicate results. By applying state-of-the-art analytical methods, you will maximise the knowledge extrapolated from our growing omics data in complex diseases impacting the project progression and future treatment options for patients with unmet medical needs.
Depending on your previous experience, your initial career level will be an Associate Principal Scientist or Senior Scientist.
Essential for the role
MSc with extensive industry experience, or preferably, PhD or equivalent in bioinformatics, data science, statistics, biostatistics, mathematics, or another similar subject area.
Experience and proficiency in large-scale omics data analysis, integration and interpretation is a requirement. Omics include transcriptomics, single cell, spatial transcriptomics. proteomics (Olink, LC/MS), genomics, and other types of next generation sequencing (NGS) such as chromatin state approaches.
Excellent coding skills in Python, R, or similar language appropriate for large scale omics analysis and experience with version control (Git/Bitbucket).
A good understanding of life sciences and how omics data can be utilised to derive biological insight will be a minimum requirement. Experience from applying this across different phases of pharmaceutical discovery and development is a preference.
Outstanding communication and collaboration skills, both with experts and non-experts, and with peers as well as stakeholders is expected. Our team is a collaborative group, so the ability to be comfortable working in a goal-oriented way, with a team focused approach is central to be successful in the role.
We believe you also have a high degree of independence and a proactive and delivery focused approach.

Desirable for the role
Experience in pharmaceutical R&D and/or Post-doc experience.
Molecular understanding of human diseases, patient stratification and biomarker-based endpoint generation, preferentially in respiratory and immunological disorders.
Track record of applying bioinformatic analysis to drive projects in drug discovery or development in an industrial or academic setting.
Broad experience applying machine learning methods such as random forests, clustering, dimensionality reduction in a systems biology or systems medicine context.
Working in a Linux environment, ideally with experience of cluster or cloud computing (e.g. AWS or Azure).
Experience from leading projects with internal groups/external collaborators.
Experience working within cross-functional teams.

Why AstraZeneca?
At AstraZeneca we turn ideas into life changing medicines and strive to continuously meet the unmet needs of patients worldwide. Working here means being entrepreneurial, thinking big, and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.
Work policy
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working give us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn’t mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. Visa mindre

Location: Gothenburg, Sweden
Be empowered to be innovative and creative where difference is valued
If you have a Chemistry based bachelor’s or master’s degree and a desire to explore your scientific potential within a global biopharmaceutical organisation, our Chemistry Research and Development (R&D) Graduate Programme could be the perfect start to your career. You’ll gain invaluable insight, exposure and opportunities across our diverse, Research and Development organisation. We’ll accelerate your learning and help you achieve your potential as a research scientist.
About AstraZeneca
AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world’s most serious diseases. We are a company that genuinely follows the science and values individuals at all levels, you’ll be backed and encouraged to speak up, ask questions, and share ideas to push the boundaries of science and continuously learn and explore.
At AstraZeneca, we unlock the power of what science can do by empowering you to explore, everyday we work towards our ultimate aim – treating, preventing, modifying and even curing complex diseases.
What is the R&D Graduate programme?
Starting in September 2023, the programme lasts two years, consisting of three individual eight month placements. Each placement will provide you with fantastic insights in to drug discovery and development and the opportunity to expand your knowledge of our therapy areas.
The programme’s variety and flexibility provides you with unique exposure to expand your knowledge, skills and interest in Chemistry research and other scientific disciplines, research areas and stages of the drug discovery process. As well as helping you broaden your scientific knowledge, we’ll help you develop professional skills required to fulfill your career potential.
You will gain an invaluable blend of on-the-job experience and training. You’ll enjoy guidance and advice from a huge support network, including a mentor and dedicated programme management team. We’ll also encourage you to identify and build collaborative relationships with specialists and leaders across our organisation, and our external networks including leading academic and biotech research institutions. Together, we’ll help accelerate your development and knowledge!
Applicants applying to the Chemistry arm of the programme should have a sound knowledge of organic synthesis. Prior lab experience in this setting is advantageous, as is a knowledge of or interest in organic chemistry, formulation techniques, or common analytical techniques.
Whilst there are numerous placements to choose from, most are wet lab based placements which build on existing skillsets and support the development of new technical skills. Our Chemistry opportunities exist in organic synthetic chemistry, formulation and analytical chemistry. There are also in silico opportunities which involve the computational modelling and design of new compounds as well as wider opportunities across the R&D organization to stretch and develop you. It is expected that candidates complete at least one lab based placement related to their discipline during the course of the programme.
You will be based at the site of application throughout the duration of the 2 years, we do not offer international placements on this programme
Essential for the role
A 2:1 (UK) / GPA 3 (US) / VG Grade (Sweden) or local equivalent Bachelor’s degree, or a Master’s level qualification, in a chemistry related subject awarded in 2022 or due to be awarded before September 2023.
Knowledge of organic synthesis.
Passionate about working in drug discovery, and committed to helping to push the boundaries of science to deliver life changing medicines to patients.
Proactive problem solving and critical thinking skills.
Planning, organisational and time management skills.
Collaborative, with a partnership approach to achieving success. Visa mindre

Ribocure Pharmaceuticals AB (Ribocure) is an international R&D center focusing on oligonucleotide drug development. We are based in Gothenburg as a subsidiary of Suzhou Ribo Life Science Co., Ltd. (Ribo). Recently, we moved into our new amazing custom designed floor at GoCo Clinic, GoCo Health Innovation City in Mölndal.

We offer a vibrant collaborative and international environment where science and data are the main driving forces behind our ambition to develop game-changing medical treatments for patients. We are now looking for a biomedical technician to join the team.

This is an exciting opportunity to join the dynamic research team at Ribocure Pharmaceuticals AB. This role within the clinical team has been developed in response to the evolving research landscape with focus on excellent quality in clinical trials. You will be part of an innovative team responding to national and international priorities.

As part of the research team, you will be involved in studies across a wide range of specialties, increasing recruitment to clinical trials and growing the research portfolio into new clinical areas. You will partake in conducting in-house trials at Ribocure Clinic.



What we offer
A dynamic and stimulating scientific work environment in an integrated R&D and clinical trial unit at GoCo Clinic, Mölndal. This is initially a probation assignment of 6 months with the opportunity for later permanent employment at Ribocure.

For us, it is important that all competence and skills in the labor market are utilized. We welcome all applicants and strive for diversity.

Main duties of the job
The successful candidate will join an enthusiastic team also consisting of study nurses and study physicians. Overall duties consist of performing trial examinations, data acquisition and data entry at Ribocure Clinic. Performing measurements and maintain a research database is fundamental. Further, you will contribute in the team to tasks such as participant identification, recruitment, and follow-up in addition to any study specific procedures. A key part of the role will be to collaborate with all members of the team and therefore you must possess excellent organizational, interpersonal and communication skills and demonstrate good attention to detail.

Working for our organization
We are a friendly proactive team that support and grow its team members. Based at GoCo, Ribocure Clinic has a clear vision to become a high-volume center with excellent clinical trial quality.

Detailed job description and main responsibilities
Research experience would be advantageous but not essential, as all necessary training and support will be provided. The position will provide exciting opportunity for working across multiple medical specialties (cardiology, internal medicine, clinical physiology, and other clinical areas).

- Performing cardiovascular ultrasound scans and measurements according to specific protocols

- Performing cardiopulmonary exercise tests according to specific protocols

- Conduct documentation and reporting of the examinations

- Conduct measurements and perform exports of data

- Assist in writing manuals for data collections and coding

- Take a leading part of activities associated with data processing

- When necessary, perform venipuncture for research blood collection and blood sample handlingsisting in the coordination, development, and application of research techniques

- Database management

- Patient/trial participant identification, recruitment, and follow-up in addition to any study specific procedures

- Have effective time management and the ability to work under limited supervision

- Be able to integrate with other teams to achieve set objectives

- Be conversant with Good Clinical Practice (GCP)

- Be proficient with Microsoft Office applications (Word, Excel, Access etc)

Person specification
Education, Qualifications, Experience & Training
Essential criteria

- Be a licensed biomedical technician

- Have previous clinical experience from relevant areas (cardiology, internal medicine, clinical physiology or other)

- Be computer litterate

- Be fluent in Swedish

Desirable criteria
- Experience of education and training

- Experience in developing instructions

- Willingness to work flexibly in terms of duties to meet service needs

- Previous practical experience of clinical trials/research will be an asset but not a requirement

Skills, Knowledge & Abilities
Essential criteria
- Understanding of research methods

- Be able to perform cardiac and vascular ultrasound

- Be able to perform venipuncture

- Ability to self-manage

- Good communication and inter-personal skills

- Demonstrable commitment to personal and professional development

- Good presentation skills

- Able to work individually or as a team player

- Attention to detail

- Ability to work flexible in terms of duties

- Clear understanding of confidentiality issues - knowledge of GDPR

- Ability to use own judgment based on information available and to seek advice when unsure of appropriate response

- Ability to manage projects with limited supervision

Desirable criteria
- Be able to perform cardiopulmonary exercise test

- Ability to work occasional weekend/out of hours work as requiredAbility to travel across the VGR-area for home visits if needed

Other
Essential criteria
- Strong commitment to clinical research

- Excellent timekeeping and a flexible approach to workGood attendance record in previous posts or during training

Please apply as soon as possible by pressing Send Application.

If you have questions, please contact Dr Sara Svedlund (mailto: [email protected]).

Welcome to Ribocure!

This recruitment is quality assured by HR On Demand. Visa mindre

A specialist/expert role for Medical Evidence and Patient Engagement in Evidence Quality across the Medical Affairs organization in AstraZeneca. Responsible for developing, implementing, and maintaining PE in Evidence quality processes and metrics and training management strategies for mandatory compliance training in alignment with AZ Code of Ethics and the Global Policies, as agreed with relevant leadership teams across the Medical Evidence organization. Provides support to the Medical Evidence organization in all Regions/Countries at both global and local level to facilitate compliance with mandatory training requirements and to enable individuals to take responsibility for meeting Quality and Compliance objectives linked to patient engagement in evidence generation.
Typical Accountabilities
Medical Evidence Quality
Driving the management of relevant training matrix in all Regions/Countries at global and local level
Support Learning Management System (LMS) Job/Role owners in the management of related learning plans
Be the key contact between the LMS support team and Medical Evidence in questions related to mandatory training
Act as the Business Learning Lead for Medical Evidence
Driving the establishment and implementing policies, procedures and standards for own work and work of others, ensuring compliance with internal and external standards and regulations
Support to Medical Evidence in Quality and Compliance related systems and tools
Ensures own knowledge and knowledge of team members of best practices and new relevant developments is up to date
Interact, when applicable, with relevant Quality and Compliance functions, for example R&D Quality Assurance and Global Compliance, as well as Quality and Compliance roles in in other functions relevant to Medical Evidence deliveries.
Oversight of continuous improvement activities – including driving relevant individual activities
Contributes to an effective collaboration between the areas of Medical Affairs
Interaction other Medical functions – for example, Medical Excellence, Global Payer Evidence & Pricing
Represents Medical Evidence Quality at external events

Patient Engagement in Medical Evidence
Establish relevant policies, procedures and standards focussed on PE in Evidence, ensuring compliance with internal and external standards and regulations
Support the implementation of strategies for PE in Evidence through a network of PE process owners and subject matter experts in markets to proactively mitigate quality risks
Drive the creation and management of relevant training matrix in Global and selected Region/Country
Oversight of PE quality related metrics in selected Region/Countries, including providing guidance on developing and managing these
Tracking of Quality Issues reported with oversight of continuous improvement activities
Establish/support Patient Engagement in Quality and Compliance related systems and tools
Ensure own knowledge and knowledge of team members of best practices and new relevant developments is up to date including regulatory landscaping and competitive intelligence
Interact, when applicable, and contribute to an effective collaboration with functions, for example Global Compliance, Data privacy, Global Nom sigs, GCP, Medical Excellence, Medial TAs (global, regional, markets), Patient Affairs OBU, Patient Science (CMO), PCS
With dotted line reporting into Global Patient Engagement team maintain close interaction and collaboration

Education, Qualifications and Experience
Essential
University Degree in Life Sciences or other appropriate discipline
Minimum 5 years’ experience in pharmaceuticals or a related industry
Strong work ethics and high integrity standards
Strong patient-centric mindset to model organizational values and mission by example
Expert knowledge of training management methodologies and requirements related to the pharma industry
Knowledge of patient engagement principles
Knowledge and experience of corporate governance and relevant regulations, laws and standards
Knowledge of the overall pharmaceutical product development process, including stages of development and role of different functional areas.
Knowledge of the management of observational studies and/or clinical trials
Strong ability to work independently
Demonstrated track record in delivering a new capability or driving a change effort
Ability to collaborate with colleagues at all levels in various geographies
Project Management knowledge and experience

Desirable
Understanding of multiple aspects within Medical Affairs
Extensive knowledge of the latest technical and regulatory developments in area of expertise
Expert knowledge of quality management and good working knowledge of GXP functions and regulations.
Knowledge/previous experience in patient engagement activities, resources, and tools, especially in Evidence area
Proven leadership promoting motivation and empowerment of others to accomplish organizational objectives in a matrix environment
Innovative and creative approach to complex problem solving and confidence to make decisions when there is no certain right or wrong answer.
Creates Clarity for Others to Make Decisions: individual creates the climate for others to act decisively by clarifying roles and responsibilities and limits of decision-making.
Anticipates and/or Removes Obstacles for Others: individual anticipates and removes obstacles so that teams/workgroups can deliver results and succeed.
Demonstrates Courage to Support Decisions: individual demonstrates courage in addressing the underlying issues that prevent effective decision-making.
Effectively challenges the business and positions quality & compliance appropriately to influence decisions: Adopts a solution-oriented approach and focuses on business enablement i.e., achievement of business goals whilst mitigating risks
Managing compliance risk: Anticipates future risks and works to innovate by sharing practices with colleagues
Manages change with a positive approach to the challenges of change for self, team, and the business. Sees change as an opportunity to improve performance and add value to the business. Visa mindre

Do you have expertise in Clinical Research and Development combined with a deep understanding of the medical and scientific aspects of drug development? Are you ready to apply your expertise in a global company that pushes the boundaries of science with potential to impact million patients’ lives around the globe? Join us to develop the ground-breaking medicines of the future for Cardiovascular, Renal and Metabolic diseases!
At AstraZeneca, we work without barriers between functions at the cutting-edge of clinical science, it’s a place to rethink the future of medicine to answer some of the most complex unmet patient needs. That’s why we love it – this is the place to make a greater impact!
We are now expanding and offer the opportunity for a Physician or Scientist to join our Late Cardiovascular, Renal and Metabolism (CVRM) clinical development teams. The role will be at Director or Senior Director level depending on your previous experience. In Late CVRM you will be working cross-functionally in a truly international environment with opportunities to meet and discuss with key opinion leaders, medical and scientific experts as well as commercial and regulatory functions. You will join a team of leading specialists, driven to pursue scientific and clinical knowledge. And there’s no better place to learn - from the science, from each other and from our successes and failures. AstraZeneca is a place of opportunity with the support you need to thrive and grow.
The positions can be based at either of our dynamic global R&D site in Gothenburg Sweden or Warsaw Poland.
What you’ll do
Our therapy area aligned groups of physicians and scientists provide clinical guidance and scientific leadership for clinical development programs within AstraZeneca's global organization. This is a global role providing medical and scientific expertise in cross functional global teams to develop medicines through design, conduct and reporting of clinical studies within Cardiovascular, Renal, Metabolic, and/or Hepatic Diseases. You will work closely with the Global Clinical Head (GCH) to develop the medicine to its full potential.
In addition to collaborating seamlessly and efficiently with colleagues globally across AstraZeneca R&D, the work involves interactions with external medical experts, Regulatory Authorities, Ethics Committees, Marketing Companies and Investigators/Sites. You will also maintain a high degree of awareness on new and emerging medical and scientific development, contribute to publications and present at congresses. Additional responsibilities include:
Providing strategic medical and scientific knowledge and supporting design, initiation, execution, completion, interpretation and reporting of clinical studies
Accountability for medical and ethical components of studies including patient safety on study level in compliance with Good Clinical Practice (GCP) and regulatory requirements
Delivery of the clinical and scientific components of all relevant study documents (e.g. Protocol, Statistical Analysis Plan, Informed Consent Form)
Accountability for ensuring safety surveillance on a study level including the process for Adverse Events (AE)/ Serious AE reporting
Depending on experience, you may work as a GCH delegate across several studies and can be the clinical representative on indication Global Product Team and other sub-teams

Essential for the role
Medical (M.D.) or Scientific (Ph.D.) degree in relevant area
Good general medical knowledge preferably in nephrology, cardiology, metabolic diseases, or NASH (by specialty training or specific research experience)
Significant academic or pharmaceutical industry experience in clinical research
Excellent English, both spoken and written
Willing to be office based at one of our AstraZeneca sites in Gothenburg or Warsaw

With your excellent interpersonal, communication, and collaboration skills you have the ability to operate effectively across boundaries in a global matrix research environment to influence both internal and external stakeholders.
Desirable for the role
Demonstrated 3+ years clinical research expertise in relevant therapy area in study design, protocol development, monitoring and implementing clinical trials, interpreting and reporting trial results
Clinical expertise in one of our core therapy areas
Good understanding of clinical trials methodology, biostatistics, global regulatory environment and pharmacovigilance
An understanding of pharmaceutical industry R&D, particularly of major clinical milestones and of the factors which influence drug development
An understanding of the interplay between clinical, commercial objectives, drug safety and regulatory requirements



Where can I find out more?
CVRM at AstraZeneca: https://www.astrazeneca.com/our-therapy-areas/cardiovascular-renal-and-metabolism.html
AstraZeneca in Gothenburg: https://www.astrazeneca.com/our-science/gothenburg.html
AstraZeneca in Warsaw: https://careers.astrazeneca.com/poland
Life at AstraZeneca : https://careers.astrazeneca.com/inclusion-diversity
Why AstraZeneca?
AstraZeneca is a global, innovation-driven biopharmaceutical company proud to provide a unique workplace culture that inspires innovation and cross-boundary collaboration. Within this environment employees are empowered to express diverse perspectives, and are made to feel valued, energized and rewarded for their ideas and creativity. There’s no better place to see what science can do. Visa mindre

Would you like to apply your expertise in a global company that is accelerating innovative science and turn ideas into life changing medicines? Join us to discover future treatment of Cardiovascular, Renal and Metabolic diseases!
Working at AstraZeneca means being entrepreneurial, thinking big and working together to make the impossible a reality. We are now recruiting a Senior Scientist with deep knowledge in cardiovascular disease, stem cells and regenerative medicine to join the Bioscience Cardiovascular department within the Early Cardiovascular, Renal and Metabolism (eCVRM) therapeutic area at AstraZeneca in Gothenburg, Sweden. As the Senior Scientist, you will be a key player in the department with opportunity to directly influence science and capabilities to ensure cutting-edge scientific leadership both today and in the future. You will have the opportunity to work at the forefront of cardiovascular research and continue to demonstrate scientific leadership through high quality publications, conference presentations and by building networks and collaborations with key opinion leaders and academic groups.
CVRM is one of three main therapeutic research areas within AstraZeneca. Early CVRM has a patient-centric approach for discovering novel treatments for patients with cardiovascular-, chronic kidney- and metabolic disease and delivers candidate drugs into late-stage clinical development. Here you will be part of an international, open-minded, and creative working atmosphere based on collaboration and innovation. You will report to the Team Lead for In Vivo Cardiovascular Bioscience.
Main Duties and Responsibilities
You will work as an expert in cardiovascular disease and cardiac regeneration. You will generate data in the lab and have the opportunity to explore novel science required for progressing existing portfolio. Collaboration is critical for successful delivery of drug projects, and you will work closely with scientists/teams from a wide range of different functions within AstraZeneca as well as with external partners and collaborators. Responsibilities include:
Provide scientific expertise in cardiovascular disease, stem cells and regenerative medicine and maintain deep understanding of the science in heart failure and regenerative medicine
Identify and explore novel drug targets and champion these to become new projects
Take responsibility as bioscience lead in drug projects
Independently design, develop and execute in vitro and in vivo experiments for projects from target identification to clinical stage
Independently analyze and interpret generated data
Communicate data to the project teams, department, science board and at external meetings
Build and maintain a network to key internal and external stakeholders and leading research institutions
Encourage, support, and directly contribute to communications of scientific findings through publications and presentations in world class scientific journals and meetings
Work collaboratively within Bioscience and other functions throughout AstraZeneca to deliver on key project activities

Essential for the role
PhD or equivalent academic merits in cardiovascular field or regenerative medicine
Postdoc experience in regenerative medicine and stem cells
Background in drug discovery and development in the pharmaceutical industry
Very strong experience with pluripotent stem cells and various cardiovascular cells including cardiac progenitor cells, cardiomyocytes, epicardial derived cells, endothelial cells
Strong scientific background and publication track record in cardiovascular disease, cardiac regeneration or developmental biology
Extensive experience in cell and molecular biology and relevant in vitro assays within the cardiovascular area (such as proliferation), differentiation of pluripotent stem cells into cardiovascular cells, imaging, organoids
In vivo experience (rodents), including design, handling, surgery
Entrepreneurial ways of working
Good collaboration skills
Strong oral and written communication skills Visa mindre

Join the Development Quality Function

Hays Life Sciences is now looking to recruit a Quality Assurance Advisor to join the Development Quality Function for a 1-year contract assignment at AstraZeneca in Gothenburg.

AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines for some of the world's most serious diseases. But we're more than one of the world's leading pharmaceutical companies. At AstraZeneca, we're proud to have a unique workplace culture that inspires innovation and collaboration. Here, employees are empowered to express diverse perspectives - and are made to feel valued, energized and rewarded for their ideas and creativity.

The arena
Are you interested in a challenging opportunity within the Development Quality function in one of the world's leading pharmaceutical companies?

The Development Quality function is responsible for quality oversight of the pharmaceutical development activities in AstraZeneca. We are now looking for a Quality Advisor with GMP focus to our Gothenburg team. AstraZeneca's pharmaceutical development organizations manage all facets of the process of turning a molecule into a medicine which can be safely and effectively used by patients. The Quality Advisor role has a broad range of responsibilities to ensure all internal and external requirements are fulfilled for the AstraZeneca projects in the development phase.

The role
As a Quality Advisor, you will work with early product development manufacturing and packaging teams and be responsible for Development Quality release of externally manufactured Drug Product and Investigational Medicinal Product for clinical trials. You are expected to assure that activities and processes across the development chain are delivered to appropriate standards to meet regulatory expectations and assure product integrity and acceptability.

You will develop and maintain a knowledge of the quality regulations and guidelines applicable to your area and a deep scientific understanding of the products that you are supporting. In your role you will have interactions with internal and external stakeholders.

Typical Accountabilities:

* Responsible for quality Release of manufactured Drug Product, Investigational Medicinal Product for clinical trials
* Providing quality input to Manufacturing, Packaging, Labelling & Distribution activities
* Providing proactive quality advice to support the development, implementation and continuous improvement of GMP quality systems across the Clinical Supply functions and support implementation of agreed global standards
* Support the pharmaceutical development functions with investigations of deviations, changes and other quality and compliance decisions in the development projects
* Provide appropriate Quality Assurance input to business improvement projects
* Operate as part of a global organisation with an integrated mindset to create an organisation with common processes and ways of working.

Minimum requirements - Education and Experience

* Degree in pharmacy or engineering (specializing in Pharmaceuticals) with at least 3 years' experience of working within a pharmaceutical GMP environment
* Broad understanding of Quality Systems and GMP and related activities to Investigational Medicinal Product (IMP)
* Comprehensive understanding of the pharmaceutical/drug development process
* Good communicator with experience of interacting effectively across interfaces
* Understanding of Project Management processes
* Fluent in written and spoken English

Preferred requirements

* Experience preferably within a pharmaceutical manufacturing organization
* Good team working and networking skills
* Capable of making effective decisions
* Demonstrate drive and energy in the role to make a difference
* Demonstrate a high degree of personal credibility Visa mindre

Are you a forward-thinking and curious Bioinformatician with skills in large scale omic analysis or experience in clinical omic analysis? Do you also want to improve the way we discover and develop medicines? Welcome to join AstraZeneca!
We are looking for experienced Bioinformaticians to join our Bioinformatics Immunology team. In this role you will be part of our Translational Science and Experimental Medicine (TSEM) department with an open and collaborative atmosphere - and a culture that is both science-based and patient-focused. This role is located at one of our sites in either Gothenburg (Sweden) or Gaithersburg/Waltham (US).
Be encouraged and supported to think creatively in our dynamic environment. Here we are free from fear of failure, free to ask the right questions and make bold decisions. We harness digital, data science & AI to fast-forward our research. Making sure work born in a lab can make a real difference. Everyday, impacting patients’ lives across the world.
What you will do
In this role, you will work in a highly cross-functional and thriving environment together with specialist in sequencing, immunological disease, as well as data science & bioinformatics experts. You will be using e.g. machine learning techniques and network biology to integrate and analyse omic and clinical data to deliver precision medicine within immunology drug development, as well as identify novel patient groups through data mining of large cohort omic data sets. Utilisation of e.g. knowledge graphs to identify life-cycle management indications is also included in the role.
Depending on your previous experience, your initial career level will be an Associate Principal Scientist or Senior Scientist.
Essential for the role
You will apply your great skills in omic analysis, with an emphasis on analysing dynamic omic sets such as e.g. transcriptomics and proteomics generated in a clinical setting to derive biological insight and you have a MSc with extensive industry experience, or preferably, PhD or equivalent in bioinformatics, life sciences, statistics, mathematics or another similar subject area. A good knowledge level in life sciences will be a minimum requirement.
We also believe you have:
• Track record of applying bioinformatic analysis to drive projects in drug discovery or development in an industrial or academic setting
• Broad experience applying ML methods such as random forests, clustering, dimensionality reduction in a systems biology or systems medicine context
• Programming proficiency and experience with relevant software tools such as R or Python, version control (Git/Bitbucket)
• Good understanding of network biology and data integration
Our team is a collaborative group, so the ability to be comfortable working in a goal-oriented way, with a team focused approach is central to be successful in the role. Furthermore, you have great communication skills, a high degree of independence and a proactive and delivery focused approach.
Desirable for the role
• Experience in pharmaceutical R&D and knowledge of relevant disease areas, and experience in precision medicine
• Working in a Linux environment, ideally with experience of cluster or cloud computing (e.g. AWS or Azure)
• Post-doc experience or otherwise relevant data science research experience
Why AstraZeneca?
AstraZeneca is a global, BioPharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines for some of the world’s most serious disease. But we’re more than one of the world’s leading pharmaceutical companies. At AstraZeneca, it is safe to share and learn from each other – ours is an inclusive environment. Where difference is recognised and uniqueness is valued.
What’s next?
If you are ready to make a difference - apply today, and we'll make it happen together! We welcome your application (including CV and cover letter).
Where can I find out more?
Follow AstraZeneca on LinkedIn: https://www.linkedin.com/company/1603/
Follow AstraZeneca on Instagram: https://www.instagram.com/astrazeneca_careers/?hl=en
Read more about BioPharmaceuticals R&D: https://www.astrazeneca.com/r-d.html Visa mindre

Regulatory Affairs Manager / Associate Regulatory Affairs Director - Cardiovascular, Renal and Metabolism


Job Description
Do you have in depth knowledge within Regulatory Affairs and want to develop your skills within project management?
At AstraZeneca, we offer you a unique experience to work in cross functional teams with all phases of drug development, from clinical trials to marketing authorization applications worldwide. You will lead the end-to-end planning, coordination and execution of our submissions and contribute to regulatory submission strategy. Does this match your skills and ambitions for the future? Then join us to develop future treatments of Cardiovascular, Renal and Metabolic (CVRM) diseases!
AstraZeneca’s pipeline of innovative medicines is consistently growing within CVRM. Within CVRM Regulatory Affairs we take innovative regulatory approaches to bring these CVRM life-changing treatments to those who need it – working across our early and late-stage development pipeline and the business as efficiently and effectively as possible. As an industry leading CVRM Regulatory function, we’re focused and committed to the development of our products as well as to our people – providing an open and supportive space to explore, learn and develop across all regulatory roles and levels.
At AstraZeneca, we are more than 65.000 people in over 100 countries. Our aim is simply to positively impact patients’ lives together, as our pipeline of innovative medicines consistently grows. As an industry leading Regulatory function, we’re focused and committed to the development of our products as well as to our people. We provide an open and supportive space to explore, learn and develop across all regulatory roles and levels, with the aspiration to make AstraZeneca the place to build your career in Regulatory. Moreover, by introducing a Regulatory academy and laying out a development path, we want to accelerate your professional and personal growth.
The role
We are now seeking new members to join our Regulatory Affairs Management team within the CVRM therapeutic areas, in the roles as Regulatory Affairs Managers (RAM) / Associate Regulatory Affairs Directors (ARAD). These roles can be based in Gothenburg or in Södertälje, Sweden. With employees from more than 50 countries, our sites are a truly inspiring place to work.
What you’ll do
Working in the roles as Regulatory Affairs Managers (RAM) / Associate Regulatory Affairs Directors (ARAD), you will have a unique opportunity to work in cross functional teams, with all phases of drug development across geographic regions. With your knowledge, you will contribute to regulatory submission strategy, identify submission risks and opportunities, while leading simple through more complex regulatory applications and managing procedures through approval.
Your main accountabilities/responsibilities:
Lead and/or contribute to the planning, preparation, and delivery of submissions of varying complexity throughout the product’s life cycle from either a global and/or regional perspective.
Provide regulatory input/ expertise on procedural and documentation requirements as defined by Health Authorities for assigned deliverable(s) including submission delivery strategy of all dossiers and all application types per market and/or region and review of documents, e.g., response documents, study protocols, periodic safety reports
Lead multi-disciplinary project teams
Support operational and compliance activities for assigned regulatory tasks
Provide coaching, mentoring and knowledge sharing within the regulatory skill group
Contribute to and lead process improvement
Identify regulatory risks and propose mitigations to appropriate member of cross functional teams

Do you have the essential qualifications for these roles?
To be successful in these roles, we believe that you have a University degree in science or a related field. A minimum of 2 years regulatory experience within the biopharmaceutical industry or at a health authority is needed to apply for the role as Regulatory Affairs Manager. To be considered for the more senior role as Associated Regulatory Affairs Director, 4 years’ experience of Regulatory Affairs for Medicinal Products in EU, US or other regions is needed as well as proven leadership and project management skills. Both roles require drug development knowledge.
We believe that you possess good project management skills as well as leaderships skills and that you have excellent written and verbal communication skills. If you have previous experience in leading multi-disciplinary project teams, this will be an advantage.
If you are ready to invest in yourself and your regulatory career, then this is the right challenge for you.
So, what’s next?
Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you!
Welcome with your application (CV and cover letter) no later than 4 March 2023.
Where can I find out more?
Our Gothenburg site: https://www.astrazeneca.com/our-science/gothenburg.html
Life in Gothenburg: https://www.movetogothenburg.com/
Culture and atmosphere of the Gothenburg site: https://www.linkedin.com/feed/update/urn:li:activity:6496327311678410752/
Our Södertälje site:
https://www.astrazeneca.se/om-oss/verksamheten-i-sverige/Sodertalje.html Visa mindre

Pioneer a new future to meet global healthcare challenges
At AstraZeneca, we turn ideas into life changing medicines and strive to continuously meet the unmet needs of patients worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality.
Pharmaceutical Technology and Development (PT&D) is the organization that turns brilliant science into actual medicines that help millions of people. We work across the entire value chain, designing and delivering active ingredients, formulations and devices for new medicines and providing expert technical support to all AstraZeneca’s commercial drug substances and products to ensure we successfully supply medicines to patients.
Innovation Strategies & External Liaison (IS⪙) sits within PT&D, and we believe innovation is the key to long term sustainability of PT&D ’s value contribution to AstraZeneca and patients. IS⪙ is expanding its focus towards digital innovations by designing projects that together form a basis for a digital twin across PT&D and Operations, and we aim to connect with other areas in the business well. This is an opportunity to take part in shaping the future by developing excellence in internal and external collaboration.
We have a great opportunity for a Director, Business Development.
The role holder will be part of teams driving the evaluation of IS⪙’s broad innovation pipeline and new science and technology opportunities and will be accountable for managing the design, set-up of agreement and maintenance of all contracts with external partners related to science and innovation activities such as academic institutions, external technology providers and vendors providing support to prototyping and feasibility studies alongside all business development activities and engagements both internal and external.
What you’ll do
You will provide business development support in the development of IS⪙ business cases for the progression of innovation projects through the IS⪙ pipeline from ideation to implementation including but not limited to relationship and stakeholder management, identification and scouting of external opportunities and new strategic engagements with key potential and current partners.
The role requires developing a transparent and efficient contract pipeline; from initial request and project scoping through legal negotiation (IP, confidentiality, warranties, indemnities, liability etc.) to post-signature management and ongoing obligations and deliverables.
You will scope, negotiate and draft legal agreements and bespoke contracts with external partners such as academic institutions, external technology providers and vendors providing support to prototyping and feasibility studies; as well as any other innovation-driven activities in PT&D.
You will provide professional legal services and advice for contract negotiation and risk management considerations and obligations, where appropriate, liaise with Legal and Patent experts. Leading technical and financial scope related negotiations with external partners in collaboration with other expertise, understanding and managing the business opportunities arising from co-development together with external providers of digital twin-type software, including the training of digital twins by AstraZeneca data.
Other responsibilities include but are not limited to:
Acting as first point of contact for the escalation of any issues at suppliers/partners and drive business improvement by collecting and providing feedback on supplier and our own performance
Establishing productive connections with other functions within AZ (e.g., Legal, Procurement, Sourcing function within R&D).
Ensuring consistency of working practices and risk taking through networking with other colleagues active in the externalisation area.
Providing advice and support as necessary regarding externalisation activities to other functions within PT&D
Contributing to the establishment of an industry leading global model for active technology hunting and evaluation of opportunities coming out from universities, start-ups and other commercial actors
Acting as ambassador for creativity and innovation and facilitate wider understanding how PT&D can influence patient value.
Ensuring that all work is performed in accordance with appropriate Safety, Health & Environment, Quality and Compliance standards.

Essential Requirements
A solid scientific background in the pharmaceutical industry such as a BSc/MSc qualification in one of the main scientific areas is an advantage.
Proven and extensive experience of externalisation/commercialisation of technologies including set up of spin-out companies, licensing and exploitations strategies.
Proven and solid experience in the drafting and negotiation of a wide variety of legal agreements with particular focus on externalisation, innovation and commercialisation.
A track record of delivery of complex projects particularly in the externalisation area (ideally experience of working across a number of pharmaceutical fields and involvement in business development and externalisation activities).
Demonstrate ability to liaise effectively internally and externally and to influence across several functional areas.
Strong strategic and entrepreneurial thinking.

Desirable Requirements
Excellent team working and networking skills.
Strong analytical and objective thinking skills.
Ability to think beyond boundaries of own job and company, challenges status quo and seeks opportunities for business improvement.
Capable of making effective decisions, acts courageously and communicates with conviction and inspiration at all levels. Demands excellence (sets high bar) and delivers.
Demonstrate a high degree of personal credibility

Why AstraZeneca
At AstraZeneca, we 're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare. Visa mindre

QA Sterile

Hays Life Sciences is now looking to recruit a Quality Assurance Associate to join the QA Sterile team for a 1-year assignment at AstraZeneca in Södertälje.

Vi söker nu Quality Assurance Associate till vår kvalitetssäkringsgrupp inom QA Sterile som stödjer AstraZenecas största produktionsenhet Sweden Operations i Södertälje, med kvalitetssäkring.
Denna tvärfunktionella och viktiga roll gör dig till en representant för både kund och företag - du blir en nyckelperson som skyddar våra produkter, tillverkningstillstånd och patienter.

Din roll
Organisatoriskt tillhör du en grupp om ca 30 personer som stödjer den sterila tillverkningen på BFS i Snäckviken och FT i Gärtuna.

Du kommer att arbeta nära den spännande och dynamiska produktionen och vara med "där det händer". Dagligen deltar du i tvärfunktionella diskussioner vid produktionslinjen och tar avvägda beslut om hur produktionen ska löpa vidare utifrån kvalitetsaspekten. Att godkänna protokoll från tillverkningen och därmed ansvara för att våra produkter håller rätt kvalitet och uppfyller ställda krav är också en del av din vardag.

Rollen har ofta en utredande karaktär där du inhämtar fakta och använder ditt logiska tänkande för att komma fram till beslut. Arbetet är självständigt och uppgifterna breda, du har stor möjlighet till eget lärande, och som representant för ditt område behövs mod, engagemang, beslutsamhet och integritet.

Vi har ett nära samarbete inom våra grupper samt med övriga stödfunktioner såsom kvalitetskontroll, processteknik och underhåll, därför ställs höga krav på flexibilitet och god förmåga att kommunicera. Din ståndpunkt kan komma att utmanas och du behöver kunna motivera dina beslut på ett bra sätt med både övertygelse och ödmjukhet.

Vilken kompetens söker vi?

* Naturvetenskaplig universitets- eller högskoleexamen om minst 240hp inklusive kurs i Mikrobiologi 7,5 hp.
* Mycket goda kunskaper i svenska och engelska, både i tal och skrift.

Exempel på utbildning är civilingenjör inom bioteknik, kemi eller läkemedelsinriktning, eller en apotekarexamen. Det är meriterade om din utbildning uppfyller kompetenskrav för Sakkunnig i LVFS 2004:7.

Det är meriterande med erfarenhet från tillverkning, kvalitetskontroll, kvalitetssäkring av läkemedel, myndighetsinspektioner eller validering/kvalificering. Även kunskaper inom LEAN är till din fördel. Vi ser gärna att du har ett intresse för teknik, system och process.

För att lyckas i rollen är du en positiv och lösningsorienterad person som trivs med ett stort kontaktnät och bred samverkan inom olika funktioner. Du är skicklig på att se helhetsperspektiv och växla mellan långa och korta deadlines. Du har förmågan att kommunicera på ett bra, förtroendeingivande sätt, och hanterar de många kontaktytorna och ibland tuffa besluten med engagemang och integritet. Visa mindre

Job description
Research Scientist – in vivo CVRM Bioscience at AstraZeneca, Gothenburg. 

AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious diseases. At AstraZeneca, we are proud to have a unique workplace culture that inspires innovation and collaboration. Here, employees are empowered to express diverse perspectives and are made to feel valued, energized and rewarded for their ideas and creativity.

The Role
We are looking for a highly motivated and creative in vivo scientists to join the Diabetes/NASH in vivo group at AstraZeneca, Gothenburg, for an one year assignment. As an In Vivo Research Scientist, you will support AstraZeneca’s industry-leading drug portfolio within the Diabetes/NASH in vivo Bioscience Team. You will work in a cross-functional and highly matrixed environment and deliver in vivo pharmacology studies for both early and late stage projects to support the development of new and successful diabetes and NASH therapies.

This is a consulting assignment at AstraZeneca with Randstad Life Sciences. Randstad Life Sciences is specialized in competences within Life Science. As a consultant with us, you get a competitive salary, benefits and collective agreements. Your consultant manager is always there for you and ensures that you get varying and developing assignments at different companies, within different industries. At Randstad Life Sciences, your personal development is in focus, and you are offered a large network and many social activities.

Please apply at www.randstad.se, no later than 2022-11-03. Selection and interviews will be ongoing, so don't wait with your application!
If you have questions, please contact Malin Fridholm, [email protected].



Responsibilities
Execute and deliver preclinical in vivo and ex vivo studies for new drug target programs within diabetes/NASH.
Deliver comprehensive in vivo pharmacology data packages for new drug candidates, including PK/PD and efficacy studies, dose and schedule optimization.
Establish new technologies and approaches to improve or replace existing disease models that better predict clinical response.
Work collaboratively with colleagues to develop and implement work plans and timelines.


Qualifications
Minimum Requirements
MSc with a minimum of 2 years relevant experience within life sciences and in vivo pharmacology.
Experience delivering in vivo pharmacology studies in rodent models, PK/PD studies, and efficacy studies.
Experience in developing and working with in vivo rodent models.
Hand-on experience in rodent animal handling techniques, including different dosing regimens and blood sampling procedures. Surgical skills is desirable.

For us, it is important that all competence and skills in the labor market are utilized. We welcome all applicants and strive for diversity.

Application
Please apply at www.randstad.se, no later than 2022-11-03. If you have questions, please contact Malin Fridholm, [email protected].


For us, it is important that all competence and skills in the labor market are utilized. We welcome all applicants and strive for diversity.

About the company
Randstad Life Sciences specializes in the field of science and is part of Randstad, the world leader in recruitment and consulting with operations in 38 countries. With this global network, in combination with our strong local foundation, we can offer a wide range of varied and developing assignments and jobs for you who are a specialist in life science. Our mission is to help you reach your true potential with your career in focus! Visa mindre

About AstraZeneca:
AstraZeneca is a global, science-led, patient-centred biopharmaceutical company focusing on discovering, developing, and commercialising prescription medicines for some of the world’s most serious diseases. But we’re more than a global leading pharmaceutical company. At AstraZeneca, we are dedicated to being a Great Place to Work and empowering employees to push the boundaries of science, fuelled by their entrepreneurial spirit. There’s no better place to make a difference in medicine, patients, and society.
About the Postdoc Programme:
Bring your expertise, apply your knowledge, follow the science, and make a difference. AstraZeneca’s Postdoc Programme is for self-motivated individuals looking to deliver exciting, high-impact projects in a collaborative, engaging and innovative environment. You'll work with multidisciplinary scientific teams from a diverse set of backgrounds and a world-class academic mentor specifically aligned to your project. Our postdocs are respected as specialists, encouraged to speak up, and supported to share their research at conferences, publish papers, achieve their goals, and make a difference to our patients.
This is a 3-year programme, with an initial 2-year period and 1-year, merit-based extension.
About the Opportunity:
In Early Respiratory & Immunology (R&I) we are rewriting the future of these patients, evolving from pure symptom control to clinical disease modification, remission and, one day, cure! To achieve this, we tackle core disease mechanisms to slow down or stop disease, and we focus on earlier and more intelligent interventions where we implement precision medicine from the start to ensure we target patients that will respond to and benefit from treatment.
We now have a Postdoctoral Fellow Opportunity, which involves testing the hypothesis that Specialised Pro-resolving lipid Mediators (SPMs), a recently described class of lipid mediators, have the potential to resolve airway inflammation in asthma and additional respiratory diseases. SPMs have been proposed to actively resolve acute inflammatory responses and promote healing and restitution, but our understanding of SPM biosynthesis and function in the human lung remains rudimentary. The key objectives for the Postdoc will be to (1) identify the key SPMs produced in human lung tissue in response to physiologically relevant stimuli and (2) establish their biological actions in human and guinea pig lung tissue explants, airways, and cell models.
What is involved in the role?
The Postdoc will apply advanced LC/MS methodology to identify SPMs generated in human lung tissue explants and cell cultures challenged with disease-relevant stimuli. The expression of lung enzymes involved in SPM synthesis and receptors mediating their actions will be studied using targeted PCR panels as well as RNA sequencing. Gene expression data will be complemented with protein analysis by Western Blot and other immune assays. Data obtained in the human lung explants will be compared with data from similar experiments in guinea pig lung tissue, which may enable studies addressing SPM production in response to allergy challenges and pharmacological intervention in vivo. Finally, you will use lung tissue explants, isolated small airways, and cells (e.g. mast cells and macrophages) to determine if SPMs can actively arrest ongoing inflammatory responses. Functional endpoints to be studied include airway contraction, cell migration and activation, and mediator production. Single or multiplexed immunoassays will be used to detect cytokines, alarmins, and growth factors. There may also be an opportunity to study the effect of selected SPMs in a novel high-resolution guinea pig airway inflammation in vivo model.
At AstraZeneca Gothenburg, you will be mentored by Dr Henric Olsson, Head of Target Science in Translational Science and Experimental Medicine (TSEM) within the Early R&I organisation. You will join a team of dedicated Target Scientists on a mission to understand disease mechanisms at the molecular level closing the gap between bench science and bedside clinical practice.
You will also have the opportunity to work at Karolinska Institutet, where you will have the support of a leading academic advisor, Prof Sven-Erik Dahlén, a world-leading expert with more than 40 years of active translational research on lipid mediators in the context of respiratory diseases. You will have access to an impressive network of supporting academic experts at Karolinska, and there will be ample opportunity to tap into the Karolinska research community with lab meetings, scientific seminars, and participation in post doc training programmes.
This is a unique opportunity where you as a Postdoc will divide your time spent between AstraZeneca´s vibrant Gothenburg site and Karolinska Institutet in Stockholm, Sweden.
Qualification, Skills & Experience:
Essential Requirements
PhD in biochemistry, cell biology, biomedicine, pharmacology, or a related field.
Good understanding of inflammation or respiratory disease biology, including cell types, molecular pathways, and mechanisms.
Solid understanding of and experience with standard laboratory techniques and methodologies, such as mRNA analysis (PCR) and Western Blot.
Good bioinformatics and data science skills, and a strong ability to analyse and present generated data.
Strong ability to disseminate results and findings to the wider research community (scientific papers and oral presentations).



Desirable Requirements
Experience with mediator analysis by liquid chromatography/mass spectrometry (LC/MS).
The ability to articulate scientific hypotheses and address them experimentally.
Strong communication and networking skills.
Flexibility and the ability to adapt to and work efficiently in different research environments (AstraZeneca and Karolnska).
Experience with pharmacologic in vitro bioassays and/or in vivo models.



Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you! Visa mindre

Development Quality Function

Hays Life Sciences is now looking to recruit a Quality Assurance Advisor to join the Development Quality Function for a 1-year contract assignment at AstraZeneca in Gothenburg.

AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines for some of the world's most serious diseases. But we're more than one of the world's leading pharmaceutical companies. At AstraZeneca, we're proud to have a unique workplace culture that inspires innovation and collaboration. Here, employees are empowered to express diverse perspectives - and are made to feel valued, energized and rewarded for their ideas and creativity.

The arena
Are you interested in a challenging opportunity within the Development Quality function in one of the world's leading pharmaceutical companies?

The Development Quality function is responsible for quality oversight of the pharmaceutical development activities in AstraZeneca. We are now looking for a Quality Advisor with GMP focus to our Gothenburg team. AstraZeneca's pharmaceutical development organizations manage all facets of the process of turning a molecule into a medicine which can be safely and effectively used by patients. The Quality Advisor role has a broad range of responsibilities to ensure all internal and external requirements are fulfilled for the AstraZeneca projects in the development phase.

The role
As a Quality Advisor, you will work with early product development manufacturing and packaging teams and be responsible for Development Quality release of externally manufactured Drug Product and Investigational Medicinal Product for clinical trials. You are expected to assure that activities and processes across the development chain are delivered to appropriate standards to meet regulatory expectations and assure product integrity and acceptability.

You will develop and maintain a knowledge of the quality regulations and guidelines applicable to your area and a deep scientific understanding of the products that you are supporting. In your role you will have interactions with internal and external stakeholders.

Typical Accountabilities:

* Responsible for quality Release of manufactured Drug Product, Investigational Medicinal Product for clinical trials
* Providing quality input to Manufacturing, Packaging, Labelling & Distribution activities
* Providing proactive quality advice to support the development, implementation and continuous improvement of GMP quality systems across the Clinical Supply functions and support implementation of agreed global standards
* Support the pharmaceutical development functions with investigations of deviations, changes and other quality and compliance decisions in the development projects
* Provide appropriate Quality Assurance input to business improvement projects
* Operate as part of a global organisation with an integrated mindset to create an organisation with common processes and ways of working.

Minimum requirements - Education and Experience

* Degree in pharmacy or engineering (specializing in Pharmaceuticals) with at least 3 years' experience of working within a pharmaceutical GMP environment
* Broad understanding of Quality Systems and GMP and related activities to Investigational Medicinal Product (IMP)
* Comprehensive understanding of the pharmaceutical/drug development process
* Good communicator with experience of interacting effectively across interfaces
* Understanding of Project Management processes
* Fluent in written and spoken English

Preferred requirements

* Experience preferably within a pharmaceutical manufacturing organization
* Good team working and networking skills
* Capable of making effective decisions
* Demonstrate drive and energy in the role to make a difference
* Demonstrate a high degree of personal credibility Visa mindre

Do you have a passion for or experience in tissue clearing and high-resolution 3D imaging? Would you like to apply your expertise to impact the development of advanced stem cell therapies in a company that follows the science and turns ideas into life-changing medicines? Then this postdoc opportunity at AstraZeneca might be the one for you!
About AstraZeneca:
AstraZeneca is a global, science-led, patient-centred biopharmaceutical company focusing on discovering, developing, and commercialising prescription medicines for some of the world’s most serious diseases. But we’re more than a global leading pharmaceutical company. At AstraZeneca, we‘re dedicated to being a Great Place to Work and empowering employees to push the boundaries of science and fuel their entrepreneurial spirit. There’s no better place to make a difference in medicine, patients, and society.
About the Postdoc Programme:
Bring your expertise, apply your knowledge, follow the science, and make a difference. AstraZeneca’s Postdoc Programme is for self-motivated individuals looking to deliver exciting, high-impact projects in a collaborative, engaging and innovative environment. You'll work with multidisciplinary scientific teams from a diverse set of backgrounds and a world-class academic mentor specifically aligned to your project. Our postdocs are respected as specialists, encouraged to speak up, and supported to share their research at conferences, publish papers, achieve their goals and make a difference to our patients.
This is a 3-year programme, with an initial 2-year period and 1 year merit-based extension.
About the Opportunity:
We are looking for a Postdoctoral Fellow to fulfil our primary objective of determining the 3D morphological phenotype of tissues with cell transplants and study how the microenvironment affects maturation and integration of grafted cells. Specifically, you will study the local response to various phenotypes of progenitor cells and how this influences safety and efficacy endpoints. Multiplex labeling will be optimized to enable inclusion of markers specific for graft maturation as well as host inflammation and neovascularization. You will deploy AI-based algorithms to spatially determine and quantitate cell types to allow comprehensive investigation of how different cell preparations, transplantation techniques and immune suppression strategies affect graft properties and cell therapeutic outcomes.
As our post doc you will lead the develop of staining and clearing protocols for multiple organs. Find solutions to process tissues with and without cell transplants for 3D optical high-resolution imaging best suited to capture potential structural differences between cell graft and host. You will support in the development of AI-based algorithms to quantify volume of graft, vascularization and, from a safety perspective, possible pathological lesions.
Cell therapy is an evolving field with various different cell types being explored for possible disease treatments. Understanding the molecular mechanisms involved in local tissue response to cell therapy grafts is fundamental for our ability to deliver new safe and efficacious drugs. Newly developed advanced imaging methodologies provide tools to study the interaction between cell therapy products and their target tissues in ways previously not possible. High-resolution 3D imaging of whole organs enables us to spatially study how cell graft and host tissue interact short term and develop over time, under different types of immunomodulatory therapies. This knowledge is pivotal to ensure short- and long-term survival of grafts while avoiding adverse events such as aberrant graft differentiation and systemic side effects of excessive immune suppression.
The primary scientific hypothesis is that local tissue microphysiology and cell response have a pivotal effect on graft survival and subsequent development into functional tissue.
Qualification, Skills & Experience:
Essential Requirements
PhD in molecular biology, biomedical sciences, biophysics or related disciplines, preferably with a focus on molecular imaging.
Extensive technical knowledge of multiplex immunostaining and imaging techniques
In-depth understanding of histology/morphology and the physiology involved
Proven experience in optical clearing techniques



Desirable Requirements
Experience in high resolution imaging e.g., optical projection tomography, light-sheet fluorescence microscope
Experience working with AI based image analyses and using imaging software e.g., Imaris and Arivis
Curious, problem solving team player



Why Should You Apply?
This role is a great opportunity if you are interested in imaging techniques, scientific challenges, and networking. In Imaging and Data Analytics we have multimodal imaging capabilities and are either imaging, informatic or data scientists and are involved in many different projects in different disease areas. We are constantly working with new imaging approaches where you will take the lead in developing high resolution 3D imaging suitable for development of future medicines.
You will be working with imaging and data experts in the Imaging and Data Analytics team, supervised by Dr Elin Sand, Associate Director and team lead of Tissue Imaging Sciences at AstraZeneca. You will also work with our academic scientific partners, Professor Ulf Ahlgren and Tomas Alanentalo from Umeå university, to achieve high resolution 3D imaging of cell grafts in host organs. Professor Ahlgren’s research group has pioneered the development of optical 3D imaging for studies of large tissues.
Ready for an exciting, rewarding challenge? Good, because we can´t wait to hear from you!
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Visa mindre

Job description
AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious diseases. But we're more than one of the world's leading pharmaceutical companies. At AstraZeneca, we're proud to have a unique workplace culture that inspires innovation and collaboration. Here, employees are empowered to express diverse perspectives - and are made to feel valued, energized and rewarded for their ideas and creativity.

The arena
Are you interested in a challenging opportunity within the Development Quality function in one of the world’s leading pharmaceutical companies?

The Development Quality function is responsible for quality oversight of the pharmaceutical development activities in AstraZeneca. We are now looking for a Quality Advisor with GMP focus to our Gothenburg team. AstraZeneca’s pharmaceutical development organizations manage all facets of the process of turning a molecule into a medicine which can be safely and effectively used by patients. The Quality Advisor role has a broad range of responsibilities to ensure all internal and external requirements are fulfilled for the AstraZeneca projects in the development phase.

This is a consulting assignment with Randstad Life Sciences. Randstad Life Sciences is specialized in competences within Life Science. As a consultant with us, you get a competitive salary, benefits and collective agreements. Your consultant manager is always there for you and ensures that you get varying and developing assignments at different companies, within different industries. At Randstad Life Sciences, your personal development is in focus, and you are offered a large network and many social activities.



Responsibilities
As a Quality Advisor, you will work with early product development manufacturing and packaging teams and be responsible for Development Quality release of externally manufactured Drug Product and Investigational Medicinal Product for clinical trials. You are expected to assure that activities and processes across the development chain are delivered to appropriate standards to meet regulatory expectations and assure product integrity and acceptability.

You will develop and maintain a knowledge of the quality regulations and guidelines applicable to your area and a deep scientific understanding of the products that you are supporting. In your role you will have interactions with internal and external stakeholders.

Typical Accountabilities:
Responsible for quality Release of manufactured Drug Product, Investigational Medicinal Product for clinical trials
Providing quality input to Manufacturing, Packaging, Labelling & Distribution activities
Providing proactive quality advice to support the development, implementation and continuous improvement of GMP quality systems across the Clinical Supply functions and support implementation of agreed global standards
Support the pharmaceutical development functions with investigations of deviations, changes and other quality and compliance decisions in the development projects
Provide appropriate Quality Assurance input to business improvement projects
Operate as part of a global organisation with an integrated mindset to create an organisation with common processes and ways of working.




Qualifications
Minimum requirements – Education and Experience
Degree in pharmacy or engineering (specializing in Pharmaceuticals) with at least 3 years’ experience of working within a pharmaceutical GMP environment
Broad understanding of Quality Systems and GMP and related activities to Investigational Medicinal Product (IMP)
Comprehensive understanding of the pharmaceutical/drug development process
Good communicator with experience of interacting effectively across interfaces
Understanding of Project Management processes
Fluent in written and spoken English


Preferred requirements
Experience preferably within a pharmaceutical manufacturing organization
Good team working and networking skills
Capable of making effective decisions
Demonstrate drive and energy in the role to make a difference
Demonstrate a high degree of personal credibility


For us, it is important that all competence and skills in the labor market are utilized. We welcome all applicants and strive for diversity.

Application
2022-10-14, welcome with your application at www.randstad.se.


For more information: contact Veronika Knudsen, [email protected]



About the company
Randstad Life Sciences specializes in the field of science and is part of Randstad, the world leader in recruitment and consulting with operations in 38 countries. With this global network, in combination with our strong local foundation, we can offer a wide range of varied and developing assignments and jobs for you who are a specialist in life science. Our mission is to help you reach your true potential with your career in focus! Visa mindre

At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and development.
Patient Safety at AstraZeneca is now looking for Pharmacovigilance Scientists to join our Patient Safety BioPharma team. The positions will be based in Gothenburg, Sweden. We are offering opportunities at different levels (e.g. PV Scientist, Senior PV Scientist and Principal PV Scientist) depending on your expertise and previous experience.
The current positions are within the therapy areas of Cardiovascular, Renal & Metabolism and Respiratory & Immunology. The core purpose of AstraZeneca Patient Safety is to add value to AstraZeneca products, provide clear science-based guidance for investigators and prescribers to safeguard patients as well as the success of our business. Patient Safety covers the entire clinical life cycle of a drug from first time into man to withdrawal of a product from the market
What you’ll do
As a Pharmacovigilance Scientist, you work with Patient Safety Physicians and other PV Scientist(s) with review, analysis and interpretation of safety data obtained from patients who have been administered the assigned medicinal products in clinical development programs and/or from marketed use. You provide authoring and pharmacovigilance input to safety documents and regulatory reports and lead internal and external meetings to present safety data and analyses. You evaluate the clinical implications of safety data from pre-clinical studies, clinical studies, literature and other information sources to establish the safety profile of drugs and manage the risk to patients.
Essential for the role
We think you are looking for a position where you truly can make an impact and have the opportunity to collaborate across global boundaries. You have a life sciences/pharmacy/nursing degree with proven analytical skills and understanding of scientific methodology. You are curious and want to take the opportunity to learn, grow and develop from a wide range of experiences and have good attention to details. You have a flexible, team orientated attitude with solid leadership skills and you are fluent in written and spoken English. It is meriting if you have previous working experience from drug development and/or pharmacovigilance activities in a Pharmaceutical company, Academic research or Health Authority environment and if you have knowledge of pharmacovigilance regulations.
This is an exciting opportunity for professional growth in areas of drug development, science, and leadership. If you’re inspired by the possibilities of science to make a difference and ready to discover what you can do – join us.
Why AstraZeneca?
Our purpose is ambitious and so is our approach. Becoming a more agile and innovative company means building a dynamic, inspiring culture where we celebrate forward thinking and act with a sense of urgency. We are ambitious, take informed risks and learn from both success and failure. We are curious, creative and open to new ideas and ways of working. Above all, we are passionate about science and driven to always put patients first. Are you ready to move forward in your career?
So, what’s next!
We would like to know more about you. If you are interested, apply now! Visa mindre

Job description
Are you a university student looking for thesis work with start spring 2023? Are you interested in the pharmaceutical industry? Then AstraZeneca might be the one for you!

AstraZeneca offers 30 and 60 credit thesis work within different areas of the company. We are looking for motivated master students, passionate about science and willing to learn a broad range of new techniques.

Randstad Life Sciences is cooperating with AstraZeneca in this recruitment process. We only handle applications sent through Randstad’s website and they should be written in english.

This is a general advertisement for thesis work at AstraZeneca Gothenburg. Specific advertisements for the thesis projects will be published during September-October. Are you interested in doing your thesis work at AstraZeneca, we recommend that you apply here already today!

All chosen candidates need to pass a background check and an alcohol and drug test before starting the project.

About AstraZeneca
At AstraZeneca, all of our employees make a difference to patients’ lives every day. We operate in more than 100 countries around the world and are one of Sweden’s most important export companies.

With more than 2,400 employees from 50 countries, the vibrant Gothenburg site helps to support the entire life-cycle of AstraZeneca medicines, from drug discovery and clinical trials, to global commercialisation and product maintenance. Gothenburg is one of AstraZeneca’s three strategic, global R&D centres, alongside Cambridge and Gaithersburg, and plays a central role in our mission to deliver life-changing medicines to patients.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.

Responsibilities
AstraZeneca offers 30 and 60 credit thesis work within different areas of the company. We are looking for motivated master students, passionate about science and willing to learn a broad range of new techniques.

Qualifications
Currently enrolled as a student within a technical, scientific, IT or other relevant field
A strong interest in pharmaceuticals or the pharmaceutical industry
Open and comprehensive scientific mindset.
Written and oral communication skills in English
Ability to work collaboratively across boundaries and problem solve in the absence of complete information.




Application
Deadline for application: 2022-10-16
For more information: Malin Fridholm, [email protected] or Veronika Knudsen, [email protected]

About the company
Randstad Life Sciences is specialized in competences within Life Science. As a consultant with us, you get a competitive salary, benefits and collective agreements. Your consultant manager is always there for you and ensures that you get varying and developing assignments at different companies, within different industries. At Randstad Life Sciences, your personal development is in focus, and you are offered a large network and many activities.

Randstad Life Sciences specializes in the field of science and is part of Randstad, the world leader in recruitment and consulting with operations in 38 countries. With this global network, in combination with our strong local foundation, we can offer a wide range of varied and developing assignments and jobs for you who are a specialist in life science. Our mission is to help you reach your true potential with your career in focus! Visa mindre

At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and development.
Patient Safety at AstraZeneca is now looking for a Safety Physicians to join our Patient Safety BioPharma team. The positions will be based in Gothenburg, Sweden. We are offering opportunities at different levels (e.g. Safety Physician, Senior Safety Physician or Principal Safety Physician) depending on your expertise and previous experience.
The current positions are within the therapy areas of Cardiovascular, Renal & Metabolism and Respiratory & Immunology. The core purpose of AstraZeneca Patient Safety is to add value to AstraZeneca products, provide clear science-based guidance for investigators and prescribers to safeguard patients as well as the success of our business. Patient Safety covers the entire clinical life cycle of a drug from first time into man to withdrawal of a product from the market.
What you’ll do
You will get the opportunity to engage with key internal and external stakeholders to provide scientific leadership and channeling our scientific capabilities to make a positive impact on changing patients’ lives. You will get a broad global exposure to other functions involved in the R&D process within AstraZeneca, as well as an overview of how strategic direction is set within the Clinical function and how decisions are made during drug development. Your work will be integrated with cross-functional teams in Clinical Development using your expertise to put a wide variety of issues into a clinical context to make informed decisions.
You will be responsible for providing medical expertise regarding the safety profile of the product(s) and the disease area while representing the patient and Health Authority perspective. This involves working closely together with global colleagues both from within the Patient Safety Department as well as other groups in AstraZeneca. Your key tasks will include using medical judgment to understand case histories, reviewing safety data in various formats to determine any findings of potential importance, helping identify, communicate and manage safety risks and providing a Patient Safety position in meetings and documents.
Essential for the role
You who will accept the challenge have a Medical Degree, experience from clinical practice and preferably also working experience from drug development in the pharmaceutical industry. PhD degree is meriting. You have a broad understanding about Health Authority regulations and Good Clinical Practice Standards and if you have experience from working with safety evaluation and risk management - that’s great! At AstraZeneca you will fit right in if you are fluent in written and spoken English, thrive on team work, networking, communication and the ability to influence both people and science.
This is an exciting opportunity for professional growth in areas of drug development, science, and leadership. If you’re inspired by the possibilities of science to make a difference and ready to discover what you can do – join us.
Why AstraZeneca?
Our purpose is ambitious and so is our approach. Becoming a more agile and innovative company means building a dynamic, inspiring culture where we celebrate forward thinking and act with a sense of urgency. We are ambitious, take informed risks and learn from both success and failure. We are curious, creative and open to new ideas and ways of working. Above all, we are passionate about science and driven to always put patients first. Are you ready to move forward in your career?
So, what’s next!
We would like to know more about you. If you are interested, apply now! Visa mindre

Do you have in depth knowledge within Regulatory Affairs and want to develop your skills within project management?
At AstraZeneca, we offer you a unique experience to work in cross functional teams with all phases of drug development, from clinical trials to marketing authorization applications worldwide. You will lead the end-to-end planning, coordination and execution of our submissions and contribute to regulatory submission strategy. Does this match your skills and ambitions for the future? Then join us to develop future treatments in the Vaccines and Immunology Therapies Areas.
At AstraZeneca, we are more than 65.000 people in over 100 countries. Our aim is simply to positively impact patients’ lives together, as our pipeline of innovative medicines consistently grows. As an industry leading Regulatory function, we’re focused and committed to the development of our products as well as to our people. We provide an open and supportive space to explore, learn and develop across all regulatory roles and levels, with the aspiration to make AstraZeneca the place to build your career in Regulatory. Moreover, by introducing a Regulatory academy and laying out a development path, we want to accelerate your professional and personal growth.
The role
We are now seeking new members to join our Regulatory Affairs Management team within the Vaccines and Immunology Therapies Areas, in the roles as Regulatory Affairs Managers (RAM) / Associate Regulatory Affairs Directors (ARAD). These roles will be based at AstraZeneca’s dynamic R&D site in Gothenburg, Sweden. With employees from more than 50 countries, our Gothenburg site is a truly inspiring place to work.
What you’ll do
Working in the roles as Regulatory Affairs Managers (RAM) / Associate Regulatory Affairs Directors (ARAD), you will have a unique opportunity to work in cross functional teams, with all phases of drug development across geographic regions
With your knowledge, you will contribute to regulatory submission strategy, identify submission risks and opportunities, while leading simple through more complex regulatory applications and managing procedures through approval.
Your main accountabilities/responsibilities:
Lead and/or contribute to the planning, preparation, and delivery of submissions of varying complexity throughout the product’s life cycle from either a global and/or regional perspective.
Provide regulatory input/ expertise on procedural and documentation requirements as defined by Health Authorities for assigned deliverable(s) including submission delivery strategy of all dossiers and all application types per market and/or region and review of documents, e.g., response documents, study protocols, periodic safety reports
Lead multi-disciplinary project teams
Support operational and compliance activities for assigned regulatory tasks
Provide coaching, mentoring and knowledge sharing within the regulatory skill group
Contribute to and lead process improvement
Identify regulatory risks and propose mitigations to appropriate member of cross functional teams



Do you have the essential qualifications for these roles?
To be successful in these roles, we believe that you have a University degree in science or a related field. A minimum of 2 years of regulatory experience within the biopharmaceutical industry or at a health authority is needed to apply for the role as Regulatory Affairs Manager. To be considered for the more senior role as Associated Regulatory Affairs Director, a deeper understanding of Regulatory Affairs, proven leadership and project management skills are required. Both roles require drug development knowledge.
We believe that you possess good project management skills as well as leaderships skills and that you have excellent written and verbal communication skills. If you have previous experience in leading multi-disciplinary project teams, this will be an advantage.
If you are ready to invest in yourself and your regulatory career, then this is the right challenge for you.
So, what’s next?
Are you already imagining yourself joining us? Good, because we can’t wait to hear from you! Visa mindre

At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and development.
Patient Safety at AstraZeneca is now looking for Pharmacovigilance Scientists to join our Patient Safety BioPharma team. The positions will be based in Gothenburg, Sweden. We are offering opportunities at different levels (e.g. PV Scientist, Senior PV Scientist and Principal PV Scientist) depending on your expertise and previous experience.
The current positions are within the therapy areas of Cardiovascular, Renal & Metabolism and Respiratory & Immunology. The core purpose of AstraZeneca Patient Safety is to add value to AstraZeneca products, provide clear science-based guidance for investigators and prescribers to safeguard patients as well as the success of our business. Patient Safety covers the entire clinical life cycle of a drug from first time into man to withdrawal of a product from the market
What you’ll do
As a Pharmacovigilance Scientist, you work with Patient Safety Physicians and other PV Scientist(s) with review, analysis and interpretation of safety data obtained from patients who have been administered the assigned medicinal products in clinical development programs and/or from marketed use. You provide authoring and pharmacovigilance input to safety documents and regulatory reports and lead internal and external meetings to present safety data and analyses. You evaluate the clinical implications of safety data from pre-clinical studies, clinical studies, literature and other information sources to establish the safety profile of drugs and manage the risk to patients.
Essential for the role
We think you are looking for a position where you truly can make an impact and have the opportunity to collaborate across global boundaries. You have a life sciences/pharmacy/nursing degree with proven analytical skills and understanding of scientific methodology. You are curious and want to take the opportunity to learn, grow and develop from a wide range of experiences and have good attention to details. You have a flexible, team orientated attitude with solid leadership skills and you are fluent in written and spoken English. It is meriting if you have previous working experience from drug development and/or pharmacovigilance activities in a Pharmaceutical company, Academic research or Health Authority environment and if you have knowledge of pharmacovigilance regulations.
This is an exciting opportunity for professional growth in areas of drug development, science, and leadership. If you’re inspired by the possibilities of science to make a difference and ready to discover what you can do – join us.
Why AstraZeneca?
Our purpose is ambitious and so is our approach. Becoming a more agile and innovative company means building a dynamic, inspiring culture where we celebrate forward thinking and act with a sense of urgency. We are ambitious, take informed risks and learn from both success and failure. We are curious, creative and open to new ideas and ways of working. Above all, we are passionate about science and driven to always put patients first. Are you ready to move forward in your career? Visa mindre

Clinical Pharmacometrician in Respiratory & Immunology
Do you have experience and expertise in mathematical modelling and simulation, PKPD and its application in drug development? Do you also share our passion to explore possibilities of science to change lives? If yes, your next challenge might be this role at AstraZeneca!


This is an opportunity for a talented and engaged individual to join our growing Clinical Pharmacology and Quantitative Pharmacology team and develop as a Clinical Pharmacometrician supporting large and small molecule projects across full development within the therapy area of Respiratory & Immunology.


AstraZeneca is a world-leading pharmaceutical company, we focus on discovering and developing medicines that make a real difference to millions of patients. Within the Clinical Pharmacology and Safety Sciences (CPSS) function, we have a state-of-the-art quantitative clinical pharmacology group with a diverse and uniquely skilled team of clinical pharmacometricians and clinical pharmacology scientists.


Thrive in an energizing environment where challenging work goes hand in hand with development. With opportunities, recognition and bright minds, there’s no better place to unlock learning and build a long-term career.


What you’ll do:
You will work closely with clinical pharmacology scientists, physicians and other scientists and apply modelling to support the design and interpretation of clinical studies and influence key decisions in early and late clinical development.


The work includes integration of relevant data, such as dose information, pharmacokinetics, biomarkers and clinical endpoints within and across studies, compounds and development stages. Supporting informative trial designs using simulations and efficient modelling statistics is an important focus area for us. In collaboration with clinical pharmacology scientists, you’ll represent Clinical Pharmacology and Quantitative Pharmacology and be responsible for identifying and executing modelling to support model informed drug development. You will communicate your findings to other scientists within and outside of AstraZeneca and publish them in peer reviewed journals.
Requirements:


PhD or equivalent (M.Sc/Pharm.D.) level expertise in quantitative modelling , e.g. knowledge in mathematics and statistics applied to life sciences
Working knowledge of pharmacokinetics and its clinical application
Background and an understanding of clinical pharmacology aspects of drug development, preferably in both the small and large molecule setting
Experience with PK/PD analysis and statistical (pharmacometric) tools such as Phoenix Winnonlin, Nonmem, R
Biological understanding of disease and drug action
Good oral and written communication skills

Desirable for the role:


Recognized scientific expertise demonstrated by scientific publishing in the field of clinical pharmacology
Early or late phase clinical development experience/awareness.


Why AstraZeneca?
We are a global, science-led BioPharmaceutical business and our innovative medicines are used by millions of patients worldwide. It drives us to work together as one global team to achieve our goals. A supportive place where all are encouraged and achievement is recognised. Strengthening our knowledge through constructive feedback and coaching, as well as collaborating with the best.
If this sounds like the job and workplace for you – apply today! Visa mindre

Follow the science to explore and innovate
Here we are committed to making a difference. We have built our business around our passion for science. Now we are fusing data and technology with the latest scientific innovations to achieve the next wave of breakthroughs.
How we do it
We are always listening and learning from people who live with the diseases our medicines treat. It enables us to better understand their needs and, ultimately, diagnose and design the right treatments to impact patients’ lives.
Why we love it
Ultimately, it’s more than a job. We know that our work impacts people with serious conditions, many of whom have no other alternatives. That’s what drives us – the potential to impact over one billion patients worldwide.
At Late Respiratory & Immunology (Late R&I), we’re driven by innovation and our dedication to make a real-life difference in patients’ lives. That difference starts with you. We are part of the BioPharmaceutical R&D unit. Here, you will get the opportunity to work in a truly international environment and meet and discuss with key opinion leaders, other medical colleagues and authorities in basic science, as well as commercial, regulatory, and other functions.
What you’ll do
As a Clinical Research Physician, you will provide clinical mentorship and scientific leadership for clinical development programs within AstraZeneca's global organization. You will operate in a wide range of aspects in pharmaceutical medicine and lead a multitude of contacts with health authorities, colleagues and marketing companies within and outside of AstraZeneca.
You will impact clinical project teams and assist the Global Clinical Head (GCH) with the design and interpretation process, as well as establishing clear design objectives for clinical programs and studies.
We rely on you to:
Build positive relationships and networks with internal and external scientific specialists and opinion leaders
Work closely with colleagues in other functions including Patient Safety, Regulatory Affairs, Biometrics, and Clinical Operations
Be involved primarily in Late Stage (Ph2b and later) clinical programmes and additionally collaborate with clinical colleagues supporting Early Stage programs as well as Medical Affairs colleagues
Provide medical input into the content of core labelling texts and medical support for commercial activities, as well as the scientific component of the pricing and value strategy
Provide expert medical input into the preparation of regulatory documents and interactions with health authorities
Provide expert analysis and interpretation of data from ongoing studies and from the literature
Prepare and present publications at scientific meetings and congresses



Essential for the role
We believe that you are a fully qualified physician (MD or MD PhD) with pharmaceutical industry experience in late stage clinical drug development. Respiratory, Allergy & Immunology background is desirable. Willingness to travel nationally and internationally as needed for the role is expected.
You also possess:
Extensive experience in the design, execution and interpretation of Late Stage clinical trials in the Respiratory area or other therapeutic area/ specialty in clinical development
Asthma/COPD knowledge
Drug development experience
Phenomenal interpersonal skills
Excellent verbal and written communication skills in English

At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, pioneering groundbreaking methods and bringing unexpected teams together. Interested? Come and join our journey.
So, what’s next?
Are you already imagining yourself joining us? Good, because we can’t wait to hear from you!
For more information please contact: [email protected] Visa mindre

Job description
 The Global Clinical Operations Program Director (GPD) is a core global role within the Clinical Operations function of Late Stage R&D (Biopharmaceuticals and Oncology). The span of responsibilities is broad and may support one or several products depending on their size and complexity. The products supported will be in Phase 3 development or on the market, but the program may include studies in all phases of drug development. The GPD has a delegated, from Senior Global Clinical Operations Program Director (Sr GPD), responsibility for oversight of a program of global clinical studies, covering all clinical program deliverables to scope, quality, budget, time, resource and risk, ensuring new innovative design and delivery models are used appropriately. The role involves integrating strategy, design, feasibility and operational planning to ensure clinical drug development programs are aligned with priorities and strategy. The GPD will develop the core clinical program components for governance interactions with the oversight of the Sr GPD. The GPD acts as the lead for cross-functional teams in delivery of clinical activities assigned. 

 The GPD may provide project leadership for cross-functional clinical submission teams in support of regulatory marketing applications and post registration product maintenance deliverables.
 Additionally, the GPD may lead or contribute to improvement and change projects within clinical operations and/or other business areas. 

Responsibilities
 Typical Accountabilities and Responsibilities (delegated by Sr GPD)
  Lead cross functional teams of experts in the planning and delivery of a defined clinical program of studies and/or clinical activities to scope, quality, budget, time, planning the resource and managing risk.
Work closely with global study leaders to provide appropriate strategic oversight of a program of studies on behalf of Sr GPD and Clinical Program Team (CPT)
Provide clinical operations expertise into the project (e.g. country selection, feasibility, operational input into design, risks and external partner management) using new innovative design and delivery models to support governance interactions and project start-up.
Responsible for providing clinical operations expertise into the development of new business case opportunities for review by governance bodies (cost, timelines, quality, feasibility, risk)
Lead cross functional Clinical Submission Teams in planning and execution of clinical contribution to Marketing Applications, maintenance support for regulatory interactions and reports and inspection readiness.
 Lead large or complex deliverables and the process to identify and solve or escalate operational issues. Drive delivery to plan through internal or external partners (alliance partners, Clinical Research Organizations (CROs), vendors and Academic Research Organizations (AROs)).
On behalf of CPT, responsible for managing clinical plans (cost, FTEs and timelines) in business reporting system, such as PLANIT.

 Internal Job Description
 Act as AZ point of escalation for study teams for external (e.g. CRO) partners for externally managed/outsourced studies as appropriate
Responsible for leadership and program management of non-drug project work as assigned, e.g. cross functional improvement/change initiatives.
 Contribute to functional and cross-functional initiatives as Subject Matter Experts
Mentor, coach and support people development as appropriate.
Actively participate in networking both within and outside the therapeutic area, sharing best practises and lesson learnt.
Be an early adopter for new ways of working and act as ambassadors for change, driving the implementation and utilization of new initiatives. 


Qualifications
Essential
University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research. Advanced degree is preferred.
At least 10 years’ experience from within the pharmaceutical industry or similar large multinational organization.
Proven knowledge of project management tools and processes
Proven experience of clinical development / drug development process in various phases of development and therapy areas.
Proven ability to learn by working in multiple phases, TAs and/or different development situations.
Experience from leading clinical projects and deliverables or similar expertise from other areas of drug development (such as pharmaceutical development).
Ability to mentor, develop and educate staff

 
Desirable
Project management certification
Knowledge of process improvement methodology such as Lean Sigma/Change Management
 Regulatory submission experience
Proven knowledge of clinical operations
Experience with development and implementation of digital health initiatives in Clinical Studies 

For us, it is important that all competence and skills in the labor market are utilized. We welcome all applicants and strive for diversity. 

Application
 2022-07-01, selection and interviews will be ongoing. The position may be filled before the last day of application, therefore, apply as soon as possible. 


For more information: Birgitta Nyström, Consultant Manager, [email protected] 

About the company
Randstad Life Sciences specializes in the field of science and is part of Randstad, the world leader in recruitment and consulting with operations in 38 countries. With this global network, in combination with our strong local foundation, we can offer a wide range of varied and developing assignments and jobs for you who are a specialist in life science. Our mission is to help you reach your true potential with your career in focus! Visa mindre

To develop future treatments in the Respiratory and Immunology Therapy Area

Hays Life Sciences is now looking to recruit 3 Regulatory Affairs Managers to develop future treatments in the Respiratory and Immunology Therapy Area for 1-year contract assignments at AstraZeneca in Gothenburg.

Do you have knowledge within Regulatory Affairs and want to develop your skills within project management?

At AstraZeneca, we offer you a unique experience to work in cross functional teams with all phases of drug development, from clinical trials to marketing authorization applications worldwide. You will lead the end-to-end planning, coordination and execution of our submissions and contribute to regulatory submission strategy. Does this match your skills and ambitions for the future? Then join us to develop future treatments in the Respiratory and Immunology Therapy Area.

At AstraZeneca, we are more than 65.000 people in over 100 countries. Our aim is simply to positively impact patients' lives together, as our pipeline of innovative medicines consistently grows. As an industry leading Regulatory function, we're focused and committed to the development of our products as well as to our people.

The role
We are now seeking new members to join our Regulatory Affairs Management team within the Respiratory and Immunology Therapy Area, in the role as Regulatory Affairs Manager (RAM).The role will be based at AstraZeneca's dynamic R&D site in Gothenburg, Sweden. With employees from more than 50 countries, our Gothenburg site is a truly inspiring place to work.

What you'll do
Working in the role as Regulatory Affairs Manager (RAM) you will contribute to regulatory submission strategy, identify submission risks and opportunities, while leading simple through more complex regulatory applications and managing procedures through approval.

Your main accountabilities/responsibilities:

* Lead and/or contribute to the planning, preparation, and delivery of submissions of varying complexity throughout the product's life cycle from either a global and/or regional perspective.
* Provide regulatory input/ expertise on procedural and documentation requirements as defined by Health Authorities for assigned deliverable(s) including submission delivery strategy of all dossiers and all application types per market and/or region and review of documents, e.g., response documents, study protocols, periodic safety reports
* Support operational and compliance activities for assigned regulatory tasks
* Provide coaching, mentoring and knowledge sharing within the regulatory skill group
* Contribute to and lead process improvement
* Identify regulatory risks and propose mitigations to appropriate member of cross functional teams

Do you have the essential qualifications for these roles?
To be successful in this role, we believe that you have a University degree in science or a related field and a minimum of 2 years of regulatory experience within the biopharmaceutical industry or similar.
We believe that you possess good project management skills as well as leaderships skills and that you have excellent written and verbal communication skills. If you have previous experience in leading multi-disciplinary project teams, this will be an advantage.

If you are ready to invest in yourself and your regulatory career, then this is the right challenge for you. Visa mindre

Job description
Quality Assurance Advisor
AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious diseases. But we're more than one of the world's leading pharmaceutical companies. At AstraZeneca, we're proud to have a unique workplace culture that inspires innovation and collaboration. Here, employees are empowered to express diverse perspectives - and are made to feel valued, energized and rewarded for their ideas and creativity.

The arena
Are you interested in a challenging opportunity within the Development Quality function in one of the world’s leading pharmaceutical companies?

The Development Quality function is responsible for quality oversight of the pharmaceutical development activities in AstraZeneca. We are now looking for 3 Quality Advisors with GMP focus to our Gothenburg team. AstraZeneca’s pharmaceutical development organizations manage all facets of the process of turning a molecule into a medicine which can be safely and effectively used by patients. The Quality Advisor role has a broad range of responsibilities to ensure all internal and external requirements are fulfilled for the AstraZeneca projects in the development phase.

Responsibilities
The role
As a Quality Advisor, you will work with early product development manufacturing and packaging teams and be responsible for Development Quality release of internally or externally manufactured Drug Product and Investigational Medicinal Product for clinical trials. You are expected to assure that activities and processes across the development chain are delivered to appropriate standards to meet regulatory expectations and assure product integrity and acceptability.

You will develop and maintain a knowledge of the quality regulations and guidelines applicable to your area and a deep scientific understanding of the products that you are supporting. In your role you will have interactions with internal and external stakeholders.

Typical Accountabilities:
Responsible for quality Release of manufactured Drug Product, Investigational Medicinal Product for clinical trials
Providing quality input to Manufacturing, Packaging, Labelling & Distribution activities
Providing proactive quality advice to support the development, implementation and continuous improvement of GMP quality systems across the Clinical Supply functions and support implementation of agreed global standards
Support the pharmaceutical development functions with investigations of deviations, changes and other quality and compliance decisions in the development projects
Providing quality advice and approval of documentation related to equipments, facilities, IT systems and instruments e.g. maintenance, calibration, validation and change control
Provide appropriate Quality Assurance input to business improvement projects
Operate as part of a global organisation with an integrated mindset to create an organisation with common processes and ways of working.


Qualifications
Minimum requirements – Education and Experience
MSc in pharmacy or engineering (specializing in Pharmaceuticals) with at least 3 years’ experience of working within a pharmaceutical GMP environment
Broad understanding of Quality Systems and GMP and related activities to Investigational Medicinal Product (IMP)
Comprehensive understanding of the pharmaceutical/drug development process
Good communicator with experience of interacting effectively across interfaces
Understanding of Project Management processes
Fluent in written and spoken English

Preferred requirements
Experience preferably within a pharmaceutical manufacturing organization
Good team working and networking skills
Capable of making effective decisions
Demonstrate drive and energy in the role to make a difference
Demonstrate a high degree of personal credibility


Application
Deadline: 2022-03-24, selection and interviews will be ongoing. The position may be filled before the last day of application, therefore, apply as soon as possible.

For more information:
Please contact Birgitta Nyström [email protected]

About the company
Randstad Life Sciences is specialized in competences within Life Science. As a consultant with us, you get a competitive salary, benefits and collective agreements. Your consultant manager is always there for you and ensures that you get varying and developing assignments at different companies, within different industries. At Randstad Life Sciences, your personal development is in focus, and you are offered a large network and many activities.

Randstad Life Sciences specializes in the field of science and is part of Randstad, the world leader in recruitment and consulting with operations in 38 countries. With this global network, in combination with our strong local foundation, we can offer a wide range of varied and developing assignments and jobs for you who are a specialist in life science. Our mission is to help you reach your true potential with your career in focus! Visa mindre

Job description
Senior Scientist Pharmacology

Are you an experienced Scientist ready to apply your skills in a diverse and dynamic company? If your passion is science and you want to be part of a team that makes a bigger impact on patients’ lives, then there’s no better place to be.

At AstraZeneca, we believe in the potential of our people and make the most of your skills and passion. Respiratory & Immunology is one of AstraZeneca’s main therapy areas. From a research perspective we work to understand, treat, modify and ultimately cure respiratory and autoimmune diseases such as asthma, COPD, IPF, IBD, RA and SLE.

We are looking to onboard an experienced histologist with background in image analysis and ideally some pathological assessment. A successful applicant would need to have a drive for innovation and idea generation as well as excellent laboratory skills to join the Bioscience In Vivo Department within the Early Respiratory and Immunology R&D unit located in Gothenburg, Sweden.

The successful candidate will join a highly motivated team that works closely together with other departments focusing on Target Translational Science, Bioscience In vitro assays and Drug Metabolism/Pharmacokinetics to support discovery projects and to drive new exciting research. Are you ready to join us?

Responsibilities
You will contribute as a vital member of the department and in various working teams to progress our respiratory and immunological drug discovery projects. You will actively take part in scientific discussions, gain input from others and be involved in multiple project meetings to present and discuss experimental plans and data.

This is a partly lab-based role where you will be actively involved in experimental phase of histological analyses, with responsibility to coordinate, perform and evaluate experiments as well as drive the establishment of new techniques. Characterization and validation of target expression and subsequent evaluation of engagement of the target by drug treatment in both patient and in vivo tissue samples will be the key areas of your daily work. You will independently assess and report data with a clear understanding of its reliability, interpretation of findings and draw appropriate conclusions with input from others.

Qualifications
We are looking for a team player with strong background in histology and related image analysis techniques, ideally complemented by some experience in pathology and preclinical drug discovery processes.
 
Essential for the role:
PhD in a relevant discipline (area of Bioscience) ideally complemented by experience of working in a drug discovery environment or molecular pathology laboratory
Strong experimental histology skills in performing immunohistochemistry, histochemistry and in situ hybridization (RNAscope)
Knowledge in histology scoring and histomorphometry
Proven knowledge and experience in image analysis using commercial software solutions
To conduct where appropriate in parallel more than one area of work to agreed timelines
Be respectful, communicate openly and show effective collaborative behavior to obtain high quality study results
Excellent written and oral communication skills, including presentation skills. You are organized and incorporate the views of others in your communication and collaboration

Desirable for the role:
Respiratory and immunology disease knowledge, including target and mechanism knowledge and basic understanding of pharmacokinetics
Some experience in pathology
Understanding and experience with molecular biology
Independent experimental design, including understanding of statistical methods, quality control and data reporting/archiving
Good understanding of pharmacology, physiology and immunology

Why AstraZeneca?
At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and development

Application
Deadline: 2022-05-19 , selection and interviews will be ongoing. The position may be filled before the last day of application, therefore, apply as soon as possible.

For more information:
Please contact Jimmy Wadie [email protected] or Veronika Knudsen [email protected] 

About the company
 Randstad Life Sciences is specialized in competences within Life Science. As a consultant with us, you get a competitive salary, benefits and collective agreements. Your consultant manager is always there for you and ensures that you get varying and developing assignments at different companies, within different industries. At Randstad Life Sciences, your personal development is in focus, and you are offered a large network and many activities.

Randstad Life Sciences specializes in the field of science and is part of Randstad, the world leader in recruitment and consulting with operations in 38 countries. With this global network, in combination with our strong local foundation, we can offer a wide range of varied and developing assignments and jobs for you who are a specialist in life science. Our mission is to help you reach your true potential with your career in focus! Visa mindre

Job description
Processes Principal, Regulatory Processes

Do you have expertise in regulatory issues and are looking for new ways to develop? Are you highly collaborative and like to take the lead in driving process improvements? This opportunity as Processes Principal in the Regulatory Process and Compliance team might be the right opportunity for you.

At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.

Global Regulatory Excellence’s vision is to Leading enterprise wide regulatory strategies, policy and delivery - so that no patient waits. In the Regulatory Process and Compliance team we network collaboratively to enable our customer groups to operate efficient processes in a compliant manner.

Responsibilities
What you’ll do
As a Processes Principal in the Regulatory Process and Compliance team you will be working with the Processes Leads and taking responsibility for the management of assigned AstraZeneca projects-processes including implementation, communication, compliance, performance and inspection readiness. Act as technical writers and project management support to ongoing procedural document update program, including communication and training activities.
You will be accountable to execute the delivery of the processes strategy, priorities, alongside governance, authoring and lifecycle management current procedural documents. We hope that you have the drive to establish a culture of continuous improvement, high performance, flexibility and quality, emphasizing a “can do” attitude and innovative approach.

Other key responsibilities in this position:
Identify opportunities for and drives the enhancement of existing processes through knowledge of internal and external environment.
Using deep understanding of regulatory processes and regulations provide process support to regulatory teams and submissions.
Identify opportunities to improve and simplify the methodology in processes and guidance, provide practical solutions and drive to implementation.
Identify and promote innovation and new ways of working to drive efficiency and improved deliverables in all processes
Identify issues and risks and propose options to mitigate them
Provide process training to relevant functional groups.
Serve as the delegate, where appropriate, for the Process Leads
Contribute to communication and change management activities associated with process initiatives.
Working collaboratively to provide expertise and sharing best practices across all regions and in all partnerships


Qualifications
Essential for the role
A science/pharmacy/nursing degree, with relevant experience (pharmaceutical, regulatory, safety and partnership)
Experience in working cross-functionally
Leadership skills, including proven leadership of project teams experience
Thorough scientific knowledge sufficient to understand all aspects of regulatory/pharmacovigilance and partnership issues
Thorough knowledge of the drug development process
Good attention to detail
Excellent written and verbal communication skills
Proven ability to work across cultures

Desirable for the role
MSC/PhD in scientific discipline
Knowledge of new and developing regulatory and pharmacovigilance expectations
Knowledge of existing AstraZeneca external alliances and collaborative projects
Knowledge of Regulatory operating model and organisation
Experience of working in a global organisation, preferably within the pharmaceuticals industry, and of the drug development life cycle and commercial aspects of the industry


Application
Deadline: 2022-03-11, selection and interviews will be ongoing. The position may be filled before the last day of application, therefore, apply as soon as possible.

For more information:
Please contact Birgitta Nyström [email protected] 

About the company
Randstad Life Sciences is specialized in competences within Life Science. As a consultant with us, you get a competitive salary, benefits and collective agreements. Your consultant manager is always there for you and ensures that you get varying and developing assignments at different companies, within different industries. At Randstad Life Sciences, your personal development is in focus, and you are offered a large network and many activities.

Randstad Life Sciences specializes in the field of science and is part of Randstad, the world leader in recruitment and consulting with operations in 38 countries. With this global network, in combination with our strong local foundation, we can offer a wide range of varied and developing assignments and jobs for you who are a specialist in life science. Our mission is to help you reach your true potential with your career in focus! Visa mindre

Avantor Services provide a broad variety of on-site Laboratory Services for major pharmaceutical customers and work collaboratively with clients to provide the resources necessary to deliver core scientific activities.
We currently have an exciting opportunity for a Research Technician to join our service providing specialist support to the Global Cell Bank (GCB) based in Gothenburg. The AstraZeneca Global Cell Bank, is a research unit key to the functioning of a large part of Discovery R&D, through storage and supply of stocks of all mammalian cell lines used within AZ. The unit works closely with a range of customers across many AZ sites, through the purchasing of new cell lines, provision of cell lines in culture and generation of cell banks. As well as cryopreservation, storage and revival of banks, supply of cells to local customers and shipments to other sites.

About the role
This role will be focused on cell depository storage in our GCB and underpins the laboratory support operations. The laboratory technician’s role directly and indirectly supports scientists across R&D functions allowing scientists to concentrate on their core roll. The work includes registration of cells in the cell database, processing cell orders by providing cells to all cell users and be responsible for the practical aspects of all cell shipments to and from the site.
The successful candidate will report to the Research Services Manager at Avantor Services and will be task managed on a day-to day basis within the client environment.

Key Tasks
To enter data, update and maintain GCB database to ensure accurate sample tracking of cells
To work with AZ Biobank to ensure compliance with storage and tracking of human biological cells
To work with AZ research scientists across disciplines, to register cells in the cell depository

· Receipting and storing of deliveries of cells to the site
· Picking and dispatching of cells to external sites & for internal collection by site scientists
· Coordinating shipments and prepare samples for quality control testing at CROs
· Operational responsibility for freezer contents
· Accountability for all maintenance of cell freezers
· Management of role related inventory (Cell boxes, dry ice etc)
· Housekeeping of GCB facility including work stations and equipment

Skills, knowledge & competencies
· Degree in a Biological Science or experience within a cell science laboratory
· Proven willingness to work flexibly in a team with minimal direct supervision
· Experience in working with human biological samples
· Computer literate: articulate, confident and competent in the use of Microsoft Word and Excel with experience of using databases, analytical packages and presenting data using standard techniques e.g. PowerPoint, spreadsheets, computerised reports etc.
· Liquid Nitrogen handling trained
· Laboratory knowledge of research, purchasing processes and procedures, Health and Safety
· Proven ability to manage customers expectations and provide a professional level of customer service
· Excellent communicator at all levels and enjoys working as part of a team
· Self motivated, energetic, dependable, honest and attention to detail

If you would like further information about the role, please contact Joakim Bergström, Research services Manager at Avantor Services, telephone: +46730-242011
The permanent employment will start in February 2022 or after agreement. Visa mindre

Job description
Senior Clinical Information Science Specialist

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world’s most serious disease. Most importantly, we do meaningful work that changes lives. It’s our purpose that drives us, every day. Would you like to play an essential role in helping patients who need it the most?

Explore the possibility of joining us as a Senior Clinical Information Science Specialist (SCISS), within one of our key scientific focus areas; Respiratory and Immunology (R&I). Supporting the late stage drug project teams, you will be a key person for innovative use of information and data to help shape our trials, decision making and portfolio.

The position sits within our Information Practice unit, a part of the Late-stage R&I Biometrics organisation. Late-stage R&I Biometrics consists of information, statistical and programming experts for drug development in phase II and beyond. You will be part of a truly global team alongside some of the most respected specialists in the industry.

Responsibilities
What you’ll do
As a strategic information expert embedded within dynamic drug project teams, you will deliver information that clinical teams need to make decisions in the drug development process. You will be an authority on innovative use of information and data to help shape our trials and portfolio.

You will use a variety of information sources such as scientific literature, competitive intelligence, internal and external clinical trial databases and techniques such as specialist information search and analysis, data visualization and benchmarking to extract and present key relevant information.

This role works in collaboration with other Information Practice team members to drive value of information and data and provides means to capture and retain knowledge. The Senior Clinical Information Science Specialist is expected to work independently and take responsibility for specific Information Practice deliveries within a drug project, and proactively engage and influence stakeholders to identify opportunities to improve deliveries and best practice.

Significant areas for contribution are:
Support decision-making in clinical design, submission and interpretation by identifying, extracting and presenting back meaningful facts and data via internal and external information sources
Enable quality decisions by providing comprehensive access to key decisions and rationale for study designs and project milestones from phase II and throughout the project life cycle, helping the organization to grow and maintain scientific knowledge
Information strategy for project and TA, proactively assessing information gaps that needs to be filled, enable re-use of information between project and TA and define new ways of working cross projects applying knowledge of external environment and trends
Organize and structure information for drug development decisions and for reuse of information and data
Plan and work independently and take responsibility for specific deliveries within a drug project, and ensure high quality is built into deliverables
Proactively engage and influence stakeholders to identify opportunities and provide practical solutions for problems
Contribute to the development of best practice and may serve as the point of contact from the team for specific Information Practice delivery areas
Lead delivery of specific tasks with other Information Practice staff or project team members


Qualifications
Minimum requirements:
Bachelors or advanced degree in a Life Science
Experience / proven track record in the application of information and knowledge management in a clinical or scientific setting (settings could include, but are not limited to clinical drug development, medical writing, medical affairs, clinical operations, competitive intelligence, regulatory intelligence)
Good organizational skills and the ability to multitask; can set priorities and follow a timeline
Ideally a self-starter, who can work independently
Good written and verbal communication skills

Preferred experience and key factors:
Good understanding of project management techniques and methods
Knowledge of the pharmaceutical clinical drug development process (with a preference for late-stage drug development in Respiratory & immunology)


Application
Deadline: 2022-02-18 , selection and interviews will be ongoing. The position may be filled before the last day of application, therefore, apply as soon as possible.

For more information:
Please contact Veronika Knudsen [email protected] or Birgitta Nyström [email protected]

About the company
Randstad Life Sciences is specialized in competences within Life Science. As a consultant with us, you get a competitive salary, benefits and collective agreements. Your consultant manager is always there for you and ensures that you get varying and developing assignments at different companies, within different industries. At Randstad Life Sciences, your personal development is in focus, and you are offered a large network and many activities.

Randstad Life Sciences specializes in the field of science and is part of Randstad, the world leader in recruitment and consulting with operations in 38 countries. With this global network, in combination with our strong local foundation, we can offer a wide range of varied and developing assignments and jobs for you who are a specialist in life science. Our mission is to help you reach your true potential with your career in focus! Visa mindre

Job description
Senior Epidemiologist or Associate Director, Safety Epidemiolog
Do you have expertise in, and passion for drug safety and real world evidence (RWE)? Would you like to apply your expertise to evaluate the safety of medicines in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you! At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.

Why AstraZeneca?
At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey. Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you.

Responsibilities
The Senior Epidemiologist or Associate Director works independently in the design, execution, analysis, interpretation, and internal and external communication of specific epidemiological studies and literature reviews. This role requires taking a leadership role in a range of activities, including delivery of experienced epidemiology strategy, support, and scientific leadership to project teams and the epidemiology global skills group, at all stages of pharmaceutical development.

They will manage externally commissioned research projects, which includes establishing, maintaining, and expanding relationships to partner effectively with external experts and research groups to negotiate time frames, provide recommendations on resource requirements, and ensure delivery of the tasks as agreed. They will promote good epidemiological practice and represents the company’s position when interacting with external experts, collaborative groups, and contract research organizations; and will keep abreast of epidemiological developments within academia, regulatory, and among key opinion leaders.

Qualifications
Essential Requirements
Ph.D. or equivalent in pharmacoepidemiology or epidemiology. Alternatively, an MSc in pharmacoepidemiology or epidemiology with extensive work experience.
Hands-on experience in utilizing secondary data and primary data collection studies and knowledge of patient safety databases for use in generating RWE.
Ability to apply advanced epidemiological theory and techniques
Able to provide critical appraisal to study designs and published studies
Ability to work effectively with internal & external experts, collaborative groups and contract research organizations (CROs)

Desirable Requirements
A broad global pharmacovigilance knowledge including knowledge of PASS studies, post-marketing commitments and reporting requirements
Experience in the health care environment or a clinical degree.
Understanding of drug safety and medical terminology and ability to summarize medical information drug safety experience in a clinical or post-marketing environment.
Ability to effectively represent epidemiology and pharmacovigilance operations on multidisciplinary teams
Good therapeutic and disease area knowledge and knowledge of drug development and life cycle management
Knowledge and experience with drug safety reporting and regulatory compliance and experience with international drug safety eporting/regulations, including PASS and RWE studies, Risk Management Plans and Signal Management
Previous experience in managing communication with EMA and FDA
Substantial knowledge and experience in epidemiological methods and research in drug development or in a closely related academic research area
Knowledge of clinical trial activities and reporting requirements
Experience managing complex medical evidence programmes, including studies such as pragmatic trials or/and PASS


Application
Deadline: 2022-01-12, selection and interviews will be ongoing. The position may be filled before the last day of application, therefore, apply as soon as possible.

For more information, please contact Kerstin Karlsson, [email protected] or Veronika Knudsen, [email protected] 

About the company
 Randstad Life Sciences is specialized in competences within Life Science. As a consultant with us, you get a competitive salary, benefits and collective agreements. Your consultant manager is always there for you and ensures that you get varying and developing assignments at different companies, within different industries. At Randstad Life Sciences, your personal development is in focus, and you are offered a large network and many social activities.

Randstad Life Sciences specializes in the field of science and is part of Randstad, the world leader in recruitment and consulting with operations in 38 countries. With this global network, in combination with our strong local foundation, we can offer a wide range of varied and developing assignments and jobs for you who are a specialist in life science. Our mission is to help you reach your true potential with your career in focus! Visa mindre

Job description
Senior Scientist pharmacology

Are you an experienced Scientist ready to apply your skills in a diverse and dynamic company? If your passion is science and you want to be part of a team that makes a bigger impact on patients’ lives, then there’s no better place to be!

At AstraZeneca, we believe in the potential of our people and make the most of your skills and passion. Respiratory & Immunology is one of AstraZeneca’s main therapy areas. From a research perspective we work to understand, treat, modify and ultimately cure respiratory and autoimmune diseases such as asthma, COPD, IPF, IBD, RA and SLE.

We are looking for an experienced histologist with background in image analysis and ideally some pathological assessment. A successful candidate would need to have a drive for innovation and idea generation as well as excellent laboratory skills to join the Bioscience In Vivo Department within the Early Respiratory and Immunology R&D unit located in Gothenburg, Sweden.

The successful candidate will join a highly motivated team that works closely together with other departments focusing on Target Translational Science, Bioscience In vitro assays and Drug Metabolism/Pharmacokinetics to support discovery projects and to drive new exciting research. Are you ready to join us?

Responsibilities
Contribute as a vital member of the department and in various working teams to progress our respiratory and immunological drug discovery projects. You will actively take part in scientific discussions, gain input from others and be involved in multiple project meetings to present and discuss experimental plans and data.

This is a partly lab-based role where you will be actively involved in experimental phase of histological analyses, with responsibility to coordinate, perform and evaluate experiments as well as drive the establishment of new techniques. Characterization and validation of target expression and subsequent evaluation of engagement of the target by drug treatment in both patient and in vivo tissue samples will be the key areas of your daily work. You will independently assess and report data with a clear understanding of its reliability, interpretation of findings and draw appropriate conclusions with input from others.

We are looking for a team player with strong background in histology and related image analysis techniques, ideally complemented by some experience in pathology and pre-clinical drug discovery processes.

Qualifications
Essential for the role
PhD in a relevant discipline (area of Bioscience) ideally complemented by experience of working in a drug discovery environment
Strong experimental histology skills in performing immunohistochemistry, histochemistry, in situ hybridization
Knowledge in histology scoring and histomorphometry
Proven knowledge and experience in image analysis (integration, segmentation, pre-processing, reconstruction, feature classification)
Understanding and experience with molecular biology
Understanding of statistical methods, quality control and data reporting/archiving
To conduct where appropriate in parallel more than one area of work to agreed timelines
Be respectful, communicate openly and show effective collaborative behavior to obtain high quality study results
Excellent written and oral communication skills, including presentation skills. You are organized and incorporate the views of others in your communication and collaboration

Desirable for the role
Respiratory disease knowledge, including target and mechanism knowledge and basic understanding of pharmacokinetics
Some experience in pathology
Good understanding of pharmacology, physiology and immunology
Knowledge in advanced histological techniques such as Tissue Microarray, Spatial transcriptomics and Tissue optical clearing
Experience in RNAscope technology


Application
Why AstraZeneca?
At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and development

So, what’s next!
Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you.

Deadline 2021-11-27,  selection and interviews will be ongoing. The position may be filled before the last day of application, therefore, apply as soon as possible. We look forward to your application!


For more information: Kerstin Karlsson [email protected] or Veronika Knudsen [email protected]

About the company
Randstad Life Sciences specializes in the field of science and is part of Randstad, the world leader in recruitment and consulting with operations in 38 countries. With this global network, in combination with our strong local foundation, we can offer a wide range of varied and developing assignments and jobs for you who are a specialist in life science. Our mission is to help you reach your true potential with your career in focus! Visa mindre

Job description
Join us in our Site Quality Team within Development Quality!

Site Quality provides Quality oversight in the development of Investigational Medicinal Products and have the responsibility for Licence to Operate for our development site and play an important part in the commercialization of new medicines. Site Quality is a Global function, with teams located in Gothenburg (Sweden), Macclesfield, (UK), Durham (North Carolina, US) and Redwood City (US). With a portfolio encompassing both small and large molecules, combination products and cutting-edge technologies you will be a part of providing novel life-changing medicines to our patients around the globe. Ready to make a difference? Then Site Quality might be right for you!

We have exciting opportunity for a 12 months assignment as Quality Advisors, in the Site Quality Gothenburg team, who’ll be the prime source for quality & compliance advice and providing quality support to the science functions and throughout the drug development process chains.
 
This is a great opportunity for you who are strong in quality and like to work with Good Manufacturing Practice, validation and making sure quality is assured when delivering new products. 

Responsibilities
As a Quality Advisor, you are expected to assure that activities and processes across the development chain are delivered to appropriate standards to meet regulatory expectations and assure product integrity and acceptability. The Quality Advisors are responsible for Quality and GMP compliance and decisions having an impact on AZ development projects and therefore AZ’s business and external reputation. They use risk management to evaluate compliance issues and to develop solutions. The decisions are made against a background of regulations that vary depending on the stage of development and against a set of standards that require interpretation.

The role holder are expected to develop and maintain a knowledge of the quality regulations and guidelines applicable to their area and be developing a deep scientific understanding of GMP.

Operating as part of a global organization, with an integrated approach to build common processes and ways of working includes:
Provide Development Quality input the review and approval of computerized system validation documentation and data.
Responsible for QA approval of documentation related to manufacturing equipment and facilities to ensure GMP compliance, including maintenance, calibration, validation and change control.
Responsible for developing and approving GMP documentation.
Provide appropriate Quality Assurance input to business improvement projects.
Drives, role models and supports a strong lean culture that promotes standardization, simplification and continuous improvement
Development, implementation and continuous improvement of Good Manufacturing Practice (GMP) across the functions
Provide advice to support the development, implementation and continuous improvement of GMP quality systems across the functions and support implementation of agreed global standards.
Provide support and guidance to functions to satisfy external Regulatory Authority GMP inspections.


Qualifications
Minimum requirements – Education and Experience
Candidate must have experience of computerized system validation (CSV), key requirement.
MSc in Pharmacy or a Engineering degree, desirable but not necessary.
Experience of working within a Manufacturing organization, desirable with a Pharmaceutical organization but not necessary.
A broad understanding of Quality Systems and Regulations.
Comprehensive understanding of the pharmaceutical/drug development process
Good communicator with experience of interacting effectively across interfaces
Fluent in written and spoken English


Preferred requirements
Experience preferably within a Pharmaceutical Manufacturing organization
Experience of regulations
Good team working and networking skills
Capable of making effective decisions
Demonstrate a high degree of personal credibility


Application
Why AstraZeneca?
At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and development

So, what’s next!
Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you.

Deadline 2021-12-09 ,  selection and interviews will be ongoing. The position may be filled before the last day of application, therefore, apply as soon as possible. We look forward to your application!

For more information: Birgitta Nyström [email protected] or Kerstin Karlsson [email protected]

About the company
Randstad Life Sciences specializes in the field of science and is part of Randstad, the world leader in recruitment and consulting with operations in 38 countries. With this global network, in combination with our strong local foundation, we can offer a wide range of varied and developing assignments and jobs for you who are a specialist in life science. Our mission is to help you reach your true potential with your career in focus! Visa mindre

Making safer antisense oligonucleotide (ASO) therapeutics by identification and molecular characterization of novel ASO:protein interactions driving toxicity
Innovate to change the world!
AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies. A place for bold disruptors shifting from academia to industry, this is where you can think differently to cut through the noise, add value, and bring fresh thinking to our teams and projects. Collaborating across functions and international borders, you’ll share knowledge and combine strengths to take your skills, and our science, to the next level.
About the Postdoc Programme
AstraZeneca’s Postdoc Programme is for self-motivated individuals looking to tackle exciting, high impact projects in a collaborative and innovative environment.
Working with peers and professionals from a diverse set of backgrounds, together with a world class academic mentor aligned specifically to your project, you’ll be respected as a specialist, and encouraged to speak up. You’ll lead a novel and innovative research project at the interface of drug discovery and biopharmaceutical development in a multi-disciplinary scientific environment. Empowered and supported to drive the success of your project, publish papers, achieve your goals and make a difference to our patients!
Running alongside your research project, our postdoc training program will help you learn about drug discovery and development from industry leaders working in our innovative research laboratories and organization.
About the Opportunity
Propelled by several recent regulatory approvals, the area of therapeutic oligonucleotides is rapidly expanding with an increasing number of research collaborations between biotechs, pharma companies and academia. Several recent publications have demonstrated key roles of ASOs interacting with a range of extra- and intracellular proteins, influencing both efficacy and toxicity. This postdoc project will dissect molecular details of protein:ASO interactions, how this impacts ASO function, and will investigate tissue-specificity by which proteins affect ASO properties. You will establish and adapt a range of methodologies ranging from proteomic/genomic analysis to high resolution microscopy and functional genetics.
You will spend most of the time in the labs of AstraZeneca Gothenburg, working alongside and with AZ scientists, postdocs and PhD students. AstraZeneca is investing broadly in solving many of the remaining knowledge gaps and challenges in the design and safety assessment of ASO therapeutics. With several colleagues working on related ASO questions, an inspiring and thriving working environment has been created to push the boundaries of science through successful and impactful publications.
Between AstraZeneca and the MRC Toxicology unit, we have created a virtual lab group with regular meetings and journal clubs. The postdoc will have the opportunity to work with academics during lab visits to University of Cambridge, allowing integration with the vibrant Cambridge bioscience community. We assume that you will take active part in these interactions to learn from others and serve as an inspiration to more junior colleagues.
Essential Education and Experience
We are looking for a strong communicator who is curious and collaborative, and is able to work independently, with a result oriented, problem solving attitude.
Required:
PhD in biochemistry, molecular biology or cell biology
Hands-on wet lab experience using standard lab-based techniques of molecular cell biology with expertise in any of the following areas:
Biochemistry
Cell biology
RNA biology
Strong publication record and experience in scientific writing
Curious and collaborative team player
Fluent in spoken and written English

Desirable:
Hands-on wet lab experience of one or several of the following experimental areas:
Cellular imaging
RNA: protein interactions
Genomics
Proteomics
Chemical biology

This is a 3-year programme. 2 years will be a Fixed Term Contract, with a 1-year extension which will be merit based. Visa mindre

To modulate protein-protein interactions in cell signaling.
AstraZeneca is a global, science-led, patient-centered biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we're dedicated to being a Great Place to Work where you are empowered to push the boundaries of science and fuel your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society.
About the Postdoc Programme
Bring your expertise, apply your knowledge, follow the science, and make a difference!
AstraZeneca’s Postdoc Programme is for self-motivated individuals looking to take on exciting, high impact projects in a collaborative and innovative environment.
Working with peers and professionals from a diverse set of backgrounds, together with an elite academic mentor explicitly aligned to your project, you'll be respected as a specialist and encouraged to speak up. You'll lead a novel and innovative research project at the interface of drug discovery and biopharmaceutical development in a multidisciplinary scientific environment. You'll be empowered and supported to drive the success of your project, publish papers, achieve your goals and make a difference to our patients!
About the Opportunity
The goal of this postdoctoral project is to generate conformationally stable protein-mimetic peptides capable of modulating the formation of multi-protein complexes involved in cell signaling.
Protein-Protein Interactions (PPI) are important in the regulation of signaling pathways and modulation of PPI is a long-standing challenge in drug discovery. One strategy which has shown particular promise is the use of new chemical modalities such as protein-mimetic peptides. You will employ structure-based design to generate drug-like peptides as potential treatment for diseases related to malfunctioning cell signaling. The peptide-protein interactions will be characterized using X-ray crystallography and biophysical methods.
You will be working alongside Dr. Jenny Sandmark, (structural biology and biophysics) and Dr. Anaïs Noisier (peptide chemistry), at AstraZeneca Gothenburg and in collaboration with your academic advisor, Prof. David Craik (University of Queensland, Australia) who is a world-leading expert in the synthesis and structural characterization of conformationally stabilized peptides. You will be leading your own project in a multicultural environment and have access to state-of-the-art equipment and facilities.
This role will give you the opportunity to work across multiple teams and departments within AstraZeneca, thus gaining broad experience of the early drug discovery process. As a Postdoctoral Scientist working on developing protein-mimetic peptide therapeutics to modulate protein-protein interactions you will develop skills in a wide variety of areas including peptide chemistry, biophysics, protein expression, crystallography and learn about the fast-expanding chemical space of new drug modalities, such as peptides, oligonucleotides and drug-conjugates.
Qualification, Skills & Experience
Required:
PhD or postdoc experience in Structural Biology, Peptide Chemistry or Biochemistry.
The candidate should have a strong background in:
X-ray crystallography
Synthesis, purification and characterization of peptides
The molecular biology and protein purification skills needed to produce high quality protein
A proven record of work, published in reputable scientific journals.

Preferably all of the above, but strong experience in one and willingness to learn new methods will suffice. Since the successful applicant is expected to perform most of the experimental work, relevant practical working experience is absolutely required.
Skills:
Ability to work independently and collaboratively.
Curious, self-driven, enthusiastic and resilient.

Desirable:
Knowledge of techniques to conformationally stabilize peptides.
Excellent communication skills.
Prior experience of working in a multidisciplinary project.

This is a 3-year programme. 2 years will be a Fixed Term Contract, with a 1-year extension which will be merit-based. Visa mindre

Interaction on an Individual Cell Level using Deep Learning Based Sequence Modelling.
Innovate to change the world!
AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies. A place for bold disruptors shifting from academia to industry, this is where you can think differently to cut through the noise, add value, and bring fresh thinking to our teams and projects. Collaborating across functions and international borders, you’ll share knowledge and combine strengths to take your skills, and our science, to the next level.
About the Postdoc Programme
AstraZeneca’s Postdoc Programme is for self-motivated individuals looking to tackle exciting, high impact projects in a collaborative and innovative environment.
Working with peers and professionals from a diverse set of backgrounds, together with a world class academic mentor aligned specifically to your project, you’ll be respected as a specialist, and encouraged to speak up. You’ll lead a novel and innovative research project at the interface of drug discovery and biopharmaceutical development in a multi-disciplinary scientific environment. Empowered and supported to drive the success of your project, publish papers, achieve your goals and make a difference to our patients!
Running alongside your research project, our postdoc training program will help you learn about drug discovery and development from industry leaders working in our innovative research laboratories and organization.
About the Opportunity
This postdoc project will be based within Pharmaceutical Sciences, a branch of AstraZeneca’s R&D that specializes in getting the active drug molecule to where it needs to go. The Advanced Drug Delivery department is in turn concerned with nanomedicine development and runs a variety of projects to investigate nanoparticle engineering and nanoparticle interactions with biological systems.
The performance of nanomedicine delivery systems is dependent on their ability to optimally interact with cellular membranes, enter the cells using endocytosis, and deliver their cargo to the cell cytoplasm by promoting endosomal escape. For each of these processes there is cell-to-cell variation. The end goal in this project is to understand and predict this variation by developing deep learning-based sequence models which allow us to predict the time and magnitude of response to nanoparticle treatment, for every freely moving cell in a population. This information should further be fed into the experimental work to extract mechanistic knowledge about what is required for successful delivery of nanomedicine cargo.
In close collaboration with experienced lab and data scientists, you will have ownership of the entire modeling and analysis pipeline ranging from experimental work to advanced predictive modelling to drafting of manuscripts for publication.
Essential Education and Experience
You may hold a PhD in cell biology, biotechnology, physiology or equivalent scientific field with hands on experience with machine learning, and/or a PhD in Maths, Physics, Statistics or Computer Science with a strong curiosity about cell biology.
Required:
A passionate relationship to science, a collaborative demeanor, and the desire to help build the best working environment possible
Hands-on experience with data science and machine learning, including multivariate data analysis, data processing and visualization
Considerable experience of implementation of deep learning models in python or similar programming language enabling fast model development
Extensive experience with in-vitro cell culture and cell biological methods
Advanced microscopy, laboratory automation, high-content biology (robotic microscopy and image analysis). Preferred candidates will have a high technical aptitude and be able to demonstrate experience in most or all of these areas

Desirable:
Proven track record to drive innovative research through internalization of new techniques and technology, as well as forming internal and external collaborations
Track record of scientific excellence, with a strong publication record and engagement with the scientific community through both conferences and collaborations
Supervisory skills and experience
Knowledge of endocytosis, intracellular trafficking pathways and relevant intracellular signaling
Excellent communication skills in English (written and spoken)

This is a 3-year programme. 2 years will be a Fixed Term Contract, with a 1-year extension which will be merit based. Visa mindre

Decoding cellular uptake and trafficking pathways of oligonucleotides in a kidney-on-a-chip in vitro model using high content fluorescence imaging and advanced image analysis.
Innovate to change the world!
AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies. A place for bold disruptors shifting from academia to industry, this is where you can think differently to cut through the noise, add value, and bring fresh thinking to our teams and projects. Collaborating across functions and international borders, you’ll share knowledge and combine strengths to take your skills, and our science, to the next level.
About the Postdoc Programme
AstraZeneca’s Postdoc Programme is for self-motivated individuals looking to take on exciting, high impact projects in a collaborative and innovative environment.
Working with peers and professionals from a diverse set of backgrounds, together with a world class academic mentor aligned specifically to your project, you’ll be respected as a specialist, and encouraged to speak up. You’ll lead a novel and innovative research project at the interface of drug discovery and biopharmaceutical development in a multi-disciplinary scientific environment. Empowered and supported to drive the success of your project, publish papers, achieve your goals and make a difference to our patients!
Running alongside your research project, our postdoc training program will help you learn about drug discovery and development from industry leaders working in our innovative research laboratories and organization.
About the Opportunity
In this role, you will work with next generation therapeutics and innovative in vitro tools at one of AstraZeneca’s vibrant R&D sites, with state-of-the-art laboratory facilities. You will research and discover fundamental biological principles to help answer the critical questions the field faces today. This will give you the opportunity to champion science and technology innovations and actively contribute to advance our strategic capabilities. In this varied and hands-on role, you will establish in vitro models of the kidney to reveal mechanisms underlying renal ASO handling which will ultimately impact the development of new therapeutics.
Working collaboratively with a multinational team of expert scientists from industry and academia, Simone Stahl (Associate Director in CVRM Safety) and Anna Björnson Granqvist (Principal Scientist and Project Leader in Early CVRM Bioscience) from AstraZeneca, Dr. Pedro Caetano-Pinto (Lab Lead Experimental Urology) from the University of Greifswald, and Prof. Dr. Roos Masereeuw (Scientific Director) from the Utrecht Institute for Pharmaceutical Sciences will support you in your scientific studies as well as mentor you in your career and professional development.
We are looking for a bold scientist with a flexible, collaborative and team-oriented mentality, who will enjoy contributing to our open and positive working climate. You can independently generate creative and innovative solutions to address research questions. You thrive in multidisciplinary teams and effectively communicate, influence and establish relationships.
Essential Education and Experience
PhD or relevant post-doctoral experience in cell biology, pharmacology, or a related field
Proven expertise in fluorescence high-content imaging approaches (e.g. live cell, confocal) and associated data analysis such as algorithm development and optimization
Practical experience in cell biology approaches and successful in vitro model and assay development
Proven ability to initiate and conduct a complex research project and excellent problem-solving skills
Track record in driving innovative science demonstrated by an excellent publication record

Desirable Qualifications
Curiosity about use of computational and artificial intelligence approaches in imaging analysis
Excellent skills in cellular/molecular biology techniques and cell-based assays; experience with advanced call culture methods e.g. microfluidic systems or organs-on-a-chip would be a plus
Knowledge of endocytosis pathways and approaches to experimentally investigate these
Experience with techniques for modulating the expression and/or activity of target proteins, using pharmacological or molecular biology approaches (e.g. siRNA, CRISPR/Cas9)

This is a 3-year programme. 2 years will be a Fixed Term Contract, with a 1-year extension which will be merit based. Visa mindre

We are now recruiting a Global Clinical Operations Program Director (GPD) to the Clinical Operations function of Late Stage Development Cardiovascular, Renal and Metabolic therapy area in BioPharmaceuticals R&D.
What you’ll do
Do you want to be part of a great and passionate team in drug development? In the Clinical Operations function we operationalize the science that brings medicines to market to improve the lives of millions of patients worldwide. Humbleness for the mission but an attitude to win are true characteristics for members of our group.
The Global Clinical Operations Program Director (GPD) has a global remit with a broad span of responsibilities and stakeholders across the enterprise, providing role modelling project leadership and management for cross-functional teams. The scope is mainly Phase 3 development or medicines already on the Market, but the program may include studies in all phases of drug development. The GPD also leads clinical submission teams in support of regulatory marketing applications and post registration product maintenance phases. On top, the GPD may manage improvement or change projects within clinical operations or spanning multiple business areas.
The GPD will provide input and support to the Senior GPD in preparation for governance interactions, responsible for the planning and delivery of a defined clinical program of studies and/or clinical activities to scope, quality, budget, time; managing resource and risk.
In the GPD role you are expected to be able to work independently and be comfortable to prioritize the work for yourself and your team to meet business objectives. You will also mentor and support people development as appropriate. GPDs are early adopters for new ways of working and act as ambassadors for change when leading teams.
This role is sitting in Late Stage Development Cardiovascular, Renal and Metabolic therapy area in BioPharmaceuticals R&D and can be based at AstraZeneca’s dynamic R&D sites in Gaithersburg (US) or Gothenburg (Sweden).
Essential for the role:
University degree, preferably in medical or biological sciences or discipline associated with clinical research (Advanced degree is preferred)
Strong experience from within the pharmaceutical industry or similar large multinational organization
Proven knowledge of clinical operations, project management tools and processes
Previous experience of clinical development / drug development process in various phases of development and therapy areas
Experience from leading clinical projects and deliverables or similar expertise from other areas of drug development (such as pharmaceutical development).
Ability to mentor, develop and educate staff
Proven leadership promoting motivation and empowerment of others in order to accomplish individual, team and organizational objectives
Skilled & experienced in change management
Ability to look for and champion more efficient and effective methods/processes of delivering Clinical Development focusing on key performance metrics around reliability, productivity, cost and quality
Excellent written and verbal communication skills, negotiation, collaboration and interpersonal skills with ability to work effectively with others at all levels of the organization
Demonstrated ability to set and manage priorities, resources, performance targets and project initiatives in a regional and local environment
Integrity and high ethical standards

Desirable for the role:
Project management certification is desirable but not mandatory
Knowledge of process improvement methodology such as Lean Sigma/Change Management is desirable but not mandatory
Regulatory submission experience

Why AstraZeneca?
At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare. Visa mindre

Early drug discovery

Hays Life Sciences is now looking to recruit a Senior Research Scientist - Cellular Assay Development for early drug discovery for a 9-month contract assignment starting 2022-01-10 until 2022-09-08 at AstraZeneca in Gothenburg.

At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with integrity even in difficult situations because we are committed to doing the right thing. We continuously pursue world-class medicines in new ways, combining our people's exceptional skills with those of people from all over the globe.

As a Senior Research Scientist in cellular assay development in Gothenburg, Sweden, you'll play a pivotal role in channelling our scientific capabilities to make a positive impact on changing patients' lives. You will work within Discovery Sciences, part of AstraZeneca's BioPharmaceuticals organisation, which focuses on scientific advances in drug discovery across therapeutic areas including, respiratory and inflammation (R&I) and cardiovascular and metabolism (CVRM).
We have an exciting opportunity for you to join us as a lab-based scientist to develop state-of-the-art cell-based screening assays. These assays will be used to support discovery of therapeutic oligos in AstraZeneca's drug discovery pipeline.
To be successful in the role as Senior Research Scientist we believe you are a highly motivated scientist with a passion to make a difference for patients. We see you as a person who enjoys collaboration and team working, who holds networking skills with experience of interacting effectively across interfaces of functions, disciplines, and cultures. This goes hand in hand with strong delivery focus, problem-solving and communication skills.

Essential Requirements

* PhD in Biology, Pharmacology, Cell biology or a related discipline or a BSc/MSc degree with significant relevant experience, preferably in the pharmaceutical or biotechnology industry
* Strong experience in cell biology techniques applied to development of physiologically relevant cellular assays
* A practical understanding of a wide range of cellular assay methods and technologies including qPCR and imaging applied to compound profiling and screening
* Excellent communication skills and an ability to operate effectively in a multi-disciplinary research environment
* Ability to independently analyse and evaluate complex data and deliver data to agreed timelines

Desirable Requirements

* Expertise in a range of cell biology techniques, including mammalian cell culture, transfection methods and gene expression knock-down (RNAi or other)
* Expertise in the design, development and validation of cellular assays for compound screening and profiling including ASOs, siRNAs or saRNAs
* Experience with automation of cell assays, e.g. work with liquid handlers like Echo, BRAVO, CyBi well or Dragonfly
* Experience with design of experiments and statistical analysis of assay performance
* Track record of identifying and adopting scientific and technical advances
* Excellent problem-solving skills, not limited to own area of expertise

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. Visa mindre

Job description
Do you have experience from working with validates pharmaceutical systems? Are you proficient with JIRA and AGILE methodologies? Then this role might be the one for you! 


At AstraZeneca, all of our employees make a difference to patients’ lives every day. We operate in more than 100 countries around the world and are one of Sweden’s most important export companies.


With more than 2,400 employees from 50 countries, the vibrant Gothenburg site helps to support the entire life-cycle of AstraZeneca medicines, from drug discovery and clinical trials, to global commercialisation and product maintenance. Gothenburg is one of AstraZeneca’s three strategic, global R&D centres, alongside Cambridge and Gaithersburg, and plays a central role in our mission to deliver life-changing medicines to patients.


This position is a consulting assignment at AstraZeneca via Randstad Life Sciences.


Randstad Life Sciences is specialized in competences within Life Science. As a consultant with us, you get a competitive salary, benefits and collective agreements. Your consultant manager is always there for you and ensures that you get varying and developing assignments at different companies, within different industries. At Randstad Life Sciences, your personal development is in focus, and you are offered a large network and many social activities.

Responsibilities
Manage surveillance systems and methodologies to ensure existing processes and systems fully address the business needs
Support the business utilization of surveillance systems including troubleshooting problems and developing solutions
Support system testing and documentation
Responsible for system administration
Support data analysis requests


Qualifications
Requirements:
3+ years of experience with validated pharmaceutical systems
Proficient with JIRA and AGILE methodologies including use cases and user stories / sprints
Strong analytical / problem solving skills with awareness of issue escalation and resolution
Good knowledge of signal and risk management tools
Strong time management and organizational skills
Customer focused
Change management skills

Desirable:
Preferably previous experience of working within AZ environment
Bachelor’s degree in pharmaceutical / technology field
Experience of data analysis and visualization
Knowledge of pharmacovigilance area
Experience of delivering training and developing training materials

Required Technical Proficiencies:
Excel
ALM
JIRA
Spotfire (desired)

For us, it is important that all competence and skills in the labor market are utilized. We welcome all applicants and strive for diversity.

Application
2021-10-17, selection and interviews will be ongoing. The position may be filled before the last day of application, therefore, apply as soon as possible.


For more information: Birgitta Nyström [email protected] or Linnea Öster [email protected]

About the company
Randstad Life Sciences specializes in the field of science and is part of Randstad, the world leader in recruitment and consulting with operations in 38 countries. With this global network, in combination with our strong local foundation, we can offer a wide range of varied and developing assignments and jobs for you who are a specialist in life science. Our mission is to help you reach your true potential with your career in focus! Visa mindre

Job description
Do you have an interest in pharmaceutical development and working with external vendors and are you a person who would like to be part of a global team and work across many disciplines – then join us as Sourcing Project Coordinator!

Pharmaceutical Technology and Development (PT&D) apply science and technology that turns concepts into actual medicines which help millions of people. We work across the entire value chain, designing and delivering active ingredients, formulations and devices required to support new medicines – from supplies for use in toxicology studies and clinical trials to developing the technology to ensure drugs can be scaled up for commercial manufacture.

Clinical Manufacturing and Supply (CM&S) within PT&D provides an agile and flexible end-to-end Clinical Supply Chain that manufactures, outsources and delivers supplies and services to hundreds of thousands of patients across the globe. This is a consulting position at AstraZeneca in Gothenburg.

Responsibilities
We are seeking those who embrace change, show great initiative, flexibility and a willingness to learn. As a Sourcing Project Coordinator, you will both lead activities and support Sourcing Project Managers in the sourcing of services and goods required by Pharmaceutical Technology & Development and Pharmaceutical Science from external suppliers. You will be responsible for leading the internal team through supplier selection, contracting, execution and issue management at the external suppliers. These global projects span support of technical development through to Clinical Supply. The services are related to the following areas: Drug Substance, Drug Product, Devices & Intelligent Pharma, Analytical Services, Pack Label & Distribution and Comparators. This role will have a specific focus on Pack, Label & Distribution and Comparators. We are keen to receive applications from recent graduates and those with some project management, supply chain and supplier experience.

Qualifications
Minimum Requirements
BS/MS degree in relevant discipline (e.g. Pharmacy, Engineering, Science, Business or Supply Chain)
Experience of working within a Development or Supply Chain environment and working with external providers.
Appropriate depth of technical knowledge for the activity being sourced (Clinical Supply) to be able to fully understand any risks to delivery and make the best use of the technical experts on the team to make effective decisions.
Highly collaborative
Good communication skills

Desirable skills
Project management and change management skills
Supplier relationship management skills
Understanding quality principles and cGMP requirements.
Good networking skills
Exhibits a high degree of personal credibility
Knowledge of the PhSci/PT&D Project Operating Model and how the various functions interact to deliver the desired business outcomes

For us, it is important that all competence and skills in the labor market are utilized. We welcome all applicants and strive for diversity.

Application
2021-09-02, selection and interviews will be ongoing. The position may be filled before the last day of application, therefore, apply as soon as possible.

For more information: Linnea Öster, [email protected]

About the company
Randstad Life Sciences specializes in the field of science and is part of Randstad, the world leader in recruitment and consulting with operations in 38 countries. With this global network, in combination with our strong local foundation, we can offer a wide range of varied and developing assignments and jobs for you who are a specialist in life science. Our mission is to help you reach your true potential with your career in focus! Visa mindre

Job description
For an exciting consulting assignment at AstraZeneca Gothenburg we are now looking for a Dossier Manager.


As a Dossier Manager you provide a Global Regulatory Operation (GRO) interface to Regulatory partners, and your responsibility is to support and navigate submission projects to regional partners and Health Authorities and update Lifecycle Management system for defined products.


Randstad Life Sciences is specialized in competences within Life Science. As a consultant with us, you get a competitive salary, benefits and collective agreements. Your consultant manager is always there for you and ensures that you get varying and developing assignments at different companies, within different industries. At Randstad Life Sciences, your personal development is in focus, and you are offered a large network and many social activities.

Responsibilities
Your direct responsibilities:
Collaborate and serve as a navigator for the Regulatory Project Teams, regards to the operational aspects of Publishing, Submission and Tracking of Regulatory submissions
Develop and maintain strong partnerships with local and global customers and partners
Acting as the first point of contact to the expertise within GRO regards to Document publishing, Submission Publishing and Submission Tracking
Update Lifecycle Management system for defined products
Support Lifecycle Management reports to support lifecycle compliance


Qualifications
Essential Requirements:
University Degree in Science or related experience
Proven leadership skills of global cross functional project teams
Relevant experience of working in one or more areas in Regulatory Affairs in the pharmaceutical or related industry
Fluent in English, written and spoken



Desirable Requirements:
Experience of working with Regulatory document or submission publishing, understanding the different procedures, formats and market requirements
Planning for and managing submission publishing activities

For us, it is important that all competence and skills in the labor market are utilized. We welcome all applicants and strive for diversity.

Application
2021-07-09, selection and interviews will be ongoing. The position may be filled before the last day of application, therefore, apply as soon as possible.


For more information please contact consultant manager Birgitta Nyström, [email protected] or consultant manager Linnea Öster, [email protected]

About the company
Randstad Life Sciences specializes in the field of science and is part of Randstad, the world leader in recruitment and consulting with operations in 38 countries. With this global network, in combination with our strong local foundation, we can offer a wide range of varied and developing assignments and jobs for you who are a specialist in life science. Our mission is to help you reach your true potential with your career in focus! Visa mindre

Are You experienced in Clinical Research? Would you describe yourself as a hands-on type of person with a natural talent for solving issues and pushing for progress? Then we may have the right position for you! Reporting to the Head of Global Medical Affairs, you will be part of an agile team of clinical research experts developing clinical evidence to support commercial needs and regulatory requirements.
As Global Clinical Project Manager at Wellspect you are driving prioritized clinical projects. Adherence to quality, timelines and budget comes natural for you. The role requires a scientific mindset and ability to get things done. To succeed in this role you are dependent on successful collaborations with internal and external stakeholders.
Responsibilities:
Accountability for all parts of clinical project execution, ie from protocol development to report finalization
Compliance with applicable standards, rules and regulations
Ability to drive a variety of project types (e.g. size, design, geographies, indications, phases)
To manage dynamic and multidisciplinary study teams including external vendors
To represent the function in cross functional forums, eg. development projects and during audits


Qualifications / Background
Relevant medical/scientific degree, typically on MSc level
3-5 years of relevant and documented experience, preferably within Medical Device
Good knowledge in applicable regulations and standards governing clinical research eg. ISO 14155/GCP and MDR
Insight in medical device development and life cycle requirements is an advantage
Statistical and data management knowledge is beneficial, as is vendor management experience
Proficient in English (verbal and writing)


We believe that you are a positive, solution-oriented and hands-on type of person with a strong sense of accountability for your work. You enjoy the mix of working in a team as well as independently, always with an appropriate sense of urgency. You challenge and explore status quo with a clear ambition to add value, constantly striving for efficiency improvements.
The position includes some travelling. Preferably we want to fill this position as soon as possible and will assess candidate on a continuous basis, however finding the right individual is our top priority.
We look forward to hearing from You. Visa mindre