Lediga jobb som Forskare, farmakologi i Mölndal

Are you an enthusiastic scientist with skills in the field of membrane protein biology and have a passion to use your skills to contribute to the development of medicine to patients? Do you also want to join a place where our team work and collaborative atmosphere drives us forward? If yes, this might be the position for you!
Right now, we have an opportunity for a motivated Research Scientist to join the Membrane Protein Science Team at our vibrant AstraZeneca R&D site in Gothenburg, Sweden, for a one year temporary position. In this role you’ll play an important part in the Discovery Biology department within the Discovery Sciences organisation. This is a 1 year long contract with KellyOCG, but you will be fully integrated and working only with AstraZeneca.
This is a laboratory-based research position where you will apply your skills and knowledge in protein purification and recombinant protein expression, your curiosity, combined with strong team working ethics to support our early drug discovery projects. You will join our team whose remit is to deliver impactful recombinant membrane protein reagents used to power hit-finding, lead-generation, all the way to clinical candidate validation.
What you will do:
As a Research Scientist in the Membrane Protein Science Team you will be generating tailored membrane protein reagents to support projects in all phases of the discovery process. The role involves expression screening of constructs in eukaryotic hosts, large scale expression, and purification of recombinant membrane proteins to supply bioreagents to assay development, affinity screening and structure-based drug discovery.
You will plan and conduct experimental strategies and generate, interpret and report scientific data autonomously or in collaboration with colleagues. In addition, you will contribute to advance our capabilities in the production of recombinant membrane proteins used in early drug discovery.
Essential in the role:
• Master’s in molecular biology, Biotechnology, Biochemistry or a related field, and 2 years of relevant working experience.
• Expertise and proven knowledge of a wide range of methods and technologies applied to the expression, purification and characterization of membrane proteins.
• Passion for experimental laboratory-based research.
Desirable in the role:
• Experience in recombinant expression, purification, and pharmacology of GPCRs.
• Good understanding of drug discovery and how to contribute with scientific expertise within own area of expertise to drive project progression.
• Expertise in cell culture for recombinant protein expression in eukaryotic cell types.
The last day to send in your application is October 9th.
Why AstraZeneca?
Join the team that follows the science unlike anywhere else. This is the place for curious minds. Dig deep into the biology of complex disease and uncover breakthroughs. With more than 2,800 employees from over than 70 countries, our vibrant Gothenburg site is a truly inspiring place to work. Here, the history and future of scientific breakthrough come together. We believe that the diversity of our people is crucial to bringing new discoveries to life.
So, what’s next? If this sounds like the job and place for you – welcome to apply! Visa mindre

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

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

About AstraZeneca
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.
Chemistry, Manufacturing, and Controls Regulatory Affairs (CMC RA)
Our Chemistry, Manufacturing, and Control (CMC) Regulatory Affairs function spans across the product lifecycle and is responsible for the regulatory strategy relating to the development, manufacture and testing of all of our medicines.
With our expertise we interpret, anticipate and craft global Health Authority expectations to build insightful CMC and Device Regulatory Strategies.
We are the bridge between our R&D functions, Operations sites, Quality and Global Supply Teams in helping safe, effective medicines reach the right patient at the right times. We manage the timely preparation and delivery of CMC contributions to the regulatory submissions linked to medicinal products throughout the product lifecycle; including Clinical Trial Applications (CTAs), Marketing Authorisation Applications (MAAs) and all post approval activities improving the reliability and value of business critical Supply Chain changes to the AZ organization by supplying the regulatory context, intelligence and mentorship for robust approval and change management.
What you’ll do
We are looking for a Chemistry, Manufacturing and Controls Regulatory Affairs (CMC RA) Manager preferably with a Development or New Product Introduction (NPI) focus to join us in Gärtuna (Sweden), with the flexibility to work remotely for up to 2 days a week.
Being a CMC RA Manager for projects in the Development & NPI lifecycle states means that you will effectively manage the production of CMC documentation for designated product ranges to deliver against the needs of both the AZ business and the patients for internally and externally manufactured products. You will project manage global CMC regulatory submissions ensuring that project activities and documentation are delivered to the required standards.
As a CMC RA Manager you will also contribute to and own the regulatory CMC components of business-related projects, applying effective levels of interactive communication with collaborators and project team members to ensure that relevant timelines and regulatory commitments are appropriately communicated. The accountabilities also include responsibility for change management as assigned and to ensure the takeaways from own projects are shared with other co-workers/within the function.
Responsibilities:
Manage/Lead assigned projects; define and agree regulatory submission strategy, coordinate cross-functional preparation of submission content and complete data assessments to ensure the authored regulatory CMC contributions are in line with AstraZeneca and Health Authority requirements throughout the development & NPI product lifecycle stages
Leverage regulatory intelligence to optimise submission content, employing quality risk management as appropriate
Maintain regulatory databases related to submissions
Capture and communicate Health Authority approval status
Continually evolve and develop the organisation’s regulatory expertise; through proactive recording and communication of regulatory insights gained via Health Authority interactions
Build and maintain good relationships with internal and external partners to facilitate regulatory execution and delivery
Contribute to business process optimization activities, removing waste and improving efficiency
Apply GxP principles according to the stage of product lifecycle



Education, Qualifications, Skills and Experience
Crucial for the role:
Bachelor’s degree or equivalent experience in a scientific subject area
Experience in a biopharmaceutical (or related) manufacturing, technical or regulatory environment
Awareness of CMC considerations and how they apply in a regulatory environment
Project management expertise with the ability to plan, coordinate sophisticated programs of work and adapt to changing situations to ensure on time delivery
Effective communication (written and oral) and partner leadership skills
IT Skills



Desirable for the role:
Detailed understanding of current regulatory CMC requirements and the CMC contributions to clinical and/or commercial regulatory dossiers
Knowledge of the drug development and marketing application processes for pharmaceutical products
Direct/indirect Regulatory Affairs CMC experience with clinical (IND & IMPD) or marketing application (NDA or BLA) submissions for synthetics and/or biologic and biotechnology derived products
Understanding of regulations and guidance governing the manufacture of pharmaceutical products
Demonstrated research skills in understanding, interpreting and applying regulations or guidance from external sources; including industry bodies and national competent authorities
Lean capabilities
Understanding and application of appropriate risk management
Proactive in identifying and acting on opportunities to drive operational improvements



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

Are you a passionate scientist, eager to join a company at the forefront of sample management technologies? Would you like to contribute to the continuous improvement of life-changing projects? Perfect, we have a new challenge for you!
We are looking for a motivated and engaged Research Scientist to become a team member of our Compound Management team at our vibrant R&D site at AstraZeneca in Gothenburg, Sweden.
In this role you will be responsible for the storage and timely supply of chemical compounds to AstraZeneca’s drug discovery projects. Highly automated liquid handling systems will be employed to supply molecules to AstraZeneca scientists and partner organisations. You will be a part of the Discovery Sciences organisation, operating within a first-class scientific environment to support drug discovery across each of AstraZeneca’s Therapeutic Areas.
Thrive in a place where the brightest and most curious minds seamlessly come together in our inclusive environment.
What you will do
In this position, you will get the opportunity to work in a dynamic and enthusiastic environment, whilst delivering critical support to all phases of drug discovery projects and working with a broad
range of chemical modalities. You will be supporting projects by providing compounds in the requested format - assay ready plates, serially diluted mother plates, formulations and solids. Bringing in new capabilities and building new processes are core activities within our group, performed in a cross-functional collaboration setting with the drug discovery projects.
You are expected to act upon day-to-day issues that occur whilst processing samples and run Compound Management development projects to ensure continuous improvement within the local team and the global department.
Examples of typical tasks:
Designing, performing and interpreting experiments independently to investigate process improvements and evaluate new technologies.
Working closely with internal project teams to meet drug discovery needs.
Rapidly addressing customer queries with regards to Compound Management orders, software, processes and capabilities.
Achieving personal scientific visibility through project contributions, internal presentations and publications.

We work collaboratively within our Compound Management team to understand the customer needs and how to add value through our experience and capabilities. To maintain this position and provide support within agreed service levels, we actively seek ways to improve our process and exploit new technologies.
Essential for the role
Compound Management is a highly collaborative group, working to tight delivery schedules - so the ability to be comfortable working at a fast, goal-oriented pace, with a team-focused attitude, is essential to being successful in the role. Furthermore, you have excellent communication skills with a proactive delivery and customer-focused approach.
We also believe that you have:
A BSc/MSc in Chemistry/Biotechnology/Chemical engineering, with relevant experience.
Excellent communication skills and high work ethics.
Excellent problem-solving skills and ability to identify and implement improvement activities.
A track record in the performance of a range of practical skills, including non-routine complex tasks, to a high level.

We also believe that our new colleague shares our passion for science, technology and innovation and has an understanding of the drug discovery process. Previous experience of working in a compound management role and operating integrated automation equipment like liquid handlers and scheduling software is a strong merit. Some experience with IT (/Python/Java coding) is an advantage but not a requirement. 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

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.
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.
Inhalation Product Development (IPD) sits within PT&D and is responsible for the development of inhalation products including combinations. Inhalation Product Development delivers the therapies of the future through scientific leadership in drug delivery, formulation and manufacturing the final drug product.
We are now seeking a Principal Scientist to join our outstanding team.
This role leads pressurized metered dose inhaler (MDI) and dry powder inhaler (DPI) development and on-market support activities. The ideal candidate will have development experience with drug-device combination products, including inhalation products, and a working knowledge of medical device design controls. Moreover, knowledge and experience in how suspension MDI formulations interact with the valve, can, and actuator is required. In addition, the candidate should have strong problem solving and communication skills with the drive and leadership qualities needed to deliver on project goals. Experience authoring international regulatory documents is desired.
What you’ll do
Lead a global team of functional leads comprised of, at a minimum, analytical, manufacturing, product development, and device representatives for a complex global product development program
Adhere to the Product Development Process and deliver project objectives on time and to quality and budget
Plan project activities and deliverables, in collaboration with PM, with appropriate input from IPD and BPD functions and IPD LT endorsement
Communicate project delivery and technical risks to IPD LT (and IPD PDD LT) and propose mitigations; advocate for project and product opportunities
Support global harmonization efforts across inhalation portfolio and within inhaled biologic programs
Lead project team utilizing lean tools such as communication (Tier process), investigations (PPS, Level 0), and productivity (Agile PM) tools
Lead authoring for regulatory dossiers including INDs, CTAs, briefing documents, BLAs, MAAs, etc.
Represent the IPD Product Development Team at the Pharmaceutical Team level and within functional stakeholder meetings, providing technical advice in the advancement of the development of the product
Collaborate closely with IPD functional heads on a routine basis to support rapid and agile responses to project challenges and opportunities ?

Essential Requirements
Master’s degree or equivalent professional qualification
Knowledge of the drug discovery and development process, developments within the industry and within own broad area of expertise
Understanding of local compliance systems regulations
Ability to provide guidance and advice on future strategy
Understanding of patent and IP strategies
Substantial knowledge of the product development process
Proven track record of project work in inhaled development
Excellent communication skills
Proven track record of talent development
Experience of coaching people
A habit of driving continuous improvement??
Excellent written and verbal communication and presentation skills in English?

Desirable requirements
Excellent negotiation, collaboration and interpersonal skills
Ability to analyse and interpret complex situations and provide clear strategic directions for others

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.
Öppen för alla
Vi fokuserar på din kompetens, inte dina övriga förutsättningar. Vi är öppna för att anpassa rollen eller arbetsplatsen efter dina behov. 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

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.
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.
Inhalation Product Development (IPD) sits within PT&D and is responsible for the development of inhalation products including combinations. Inhalation Product Development delivers the therapies of the future through scientific leadership in drug delivery, formulation and manufacturing the final drug product.
We are now seeking a Principal Scientist to join our outstanding team.
This role leads pressurized metered dose inhaler (MDI) and dry powder inhaler (DPI) development and on-market support activities. The ideal candidate will have development experience with drug-device combination products, including inhalation products, and a working knowledge of medical device design controls. Moreover, knowledge and experience in how suspension MDI formulations interact with the valve, can, and actuator is required. In addition, the candidate should have strong problem solving and communication skills with the drive and leadership qualities needed to deliver on project goals. Experience authoring international regulatory documents is desired.
What you’ll do
Lead a global team of functional leads comprised of, at a minimum, analytical, manufacturing, product development, and device representatives for a complex global product development program
Adhere to the Product Development Process and deliver project objectives on time and to quality and budget
Plan project activities and deliverables, in collaboration with PM, with appropriate input from IPD and BPD functions and IPD LT endorsement
Communicate project delivery and technical risks to IPD LT (and IPD PDD LT) and propose mitigations; advocate for project and product opportunities
Support global harmonization efforts across inhalation portfolio and within inhaled biologic programs
Lead project team utilizing lean tools such as communication (Tier process), investigations (PPS, Level 0), and productivity (Agile PM) tools
Lead authoring for regulatory dossiers including INDs, CTAs, briefing documents, BLAs, MAAs, etc.
Represent the IPD Product Development Team at the Pharmaceutical Team level and within functional stakeholder meetings, providing technical advice in the advancement of the development of the product
Collaborate closely with IPD functional heads on a routine basis to support rapid and agile responses to project challenges and opportunities ?

Essential Requirements
Master’s degree or equivalent professional qualification
Knowledge of the drug discovery and development process, developments within the industry and within own broad area of expertise
Understanding of local compliance systems regulations
Ability to provide guidance and advice on future strategy
Understanding of patent and IP strategies
Substantial knowledge of the product development process
Proven track record of project work in inhaled development
Excellent communication skills
Proven track record of talent development
Experience of coaching people
A habit of driving continuous improvement??
Excellent written and verbal communication and presentation skills in English?

Desirable requirements
Excellent negotiation, collaboration and interpersonal skills
Ability to analyse and interpret complex situations and provide clear strategic directions for others 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

Associate Principal Scientist / Senior Scientist Bioinformatician - Translational Science and Experimental Medicine.
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. 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

At AstraZeneca, we unlock the power of What Science Can Do. Empowered to explore, every day we work towards our ultimate aim - treating, preventing, modifying and even curing complex diseases. Be part of the team where you are empowered to follow the science! Pharmaceutical Sciences (PharmSci) is responsible for the design and development of synthetic routes, preclinical and phase I/II formulations, encompassing both small molecules and new modalities such as mRNA and oligonucleotides, across the whole range of AstraZeneca’s therapeutic areas.

OM TJÄNSTEN
The manufacturing unit within Early Product Development and Manufacture (EPDM) in Gothenburg is accountable for manufacture of a large and variable portfolio of early investigational medicinal products (oral solution/suspension, parenteral solutions, capsules, tablets and inhalers), mainly for Phases I and II. We supply drug product to AZ clinical studies globally and are a vital part to enable early phase clinical trials, delivering a critical step on the path from idea to patient. In short, we are the first in line to manufacture what could improve the lives of patients around the globe.

We are now looking for a Scientist starting as soon as possible with the location Gothenburg, Sweden.

In joining EPDM and PharmSci, you will be part of an amazing group of skilled and driven colleagues who truly embrace team spirit, who you will exchange knowledge and collaborate with on many levels in various contexts. This provides excellent opportunities for your professional development, and possibilities to take on further accountabilities in line with your personal growth

ARBETSUPPGIFTER
Within the EPDM manufacturing unit, in the GMP (Good Manufacturing Practice) arena, you will make an important contribution in delivering clinical results in the development of new medicines. This role revolves around the manufacturing of drug product where all activities below will have a significant impact on the speed, quality and cost of the AZ development portfolio.

We expect the successful candidate to


* Assume responsibilities toward timely manufacture of various drug products in line with the plans agreed within EPDM and surrounding stakeholders.
* Work with practical hands-on processes in our GMP facilities following manufacturing batch records and perform transactions in material management systems.
* Monitor, secure and follow up on other regulatory requirements according to GMP through associated IT-systems.
* Rapidly develop strong competence within relevant process technologies and build credibility and ability to drive and secure product establishment, scale-up and clinical manufactures.
* Support documentation activities, e.g. by authoring manufacturing batch records, taking part in deviation investigations, authoring SOPs, and other guidance documents, change control processes etc.
* Assess records and report manufacturing and validation data accurately according to GMP.
* Ensure that SHE (Safety Health and Environment) and GMP standards are upheld and ensure AZ Policies and Standards are understood and followed.
* Be entrepreneurial and drive initiatives to further improve flexibility and productivity, resulting in shorter lead times or increased value for our customers and patients.


VI SÖKER DIG SOM
- MSc in pharmacy/engineering
- Strong verbal and documentation skills in English is a requirement.
- Desirable with experience from pharmaceutical development or working in a manufacturing or supply chain organization.
- Desirable with knowledge of cGMP.

#

Other information


* Start: As soon as possible
* Extent: Full time
* Location: Mölndal


The recruitment process is handled by Academic Work and our client wishes that all quiestions regarding the role is handled by Academic Work. We work with an ongoing selection and the advert might be closed before the role is filled if we have moved forward to the selection and interview phase.

INFORMATION OM FÖRETAGET
View more about AstraZeneca as a company here 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

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

Do you have expertise in, or passion for, novel catalytic methods for synthesis? Would you like to apply your knowledge to impact the development of novel chemical probes in a company that follows the science and turns ideas into life-changing medicines? Then 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:
In the position, you would have an excellent opportunity to acquire and hone interdisciplinary skills in emerging technologies involving automation-enabled high throughput experimentation, photoredox chemistry, flow chemistry and chemical probes which is a highly valuable set for a career in pharmaceutical industry.
Within AstraZeneca’s Early Cardiovascular, Renal and Metabolism (CVRM) medicinal chemistry department, we strive to employ novel chemical methodologies and emerging technologies to support and accelerate drug discovery programs.
We are looking for a Postdoctoral Fellow who will lead a project involving high throughput experimentation to develop photoredox-mediated, catalytic methodologies to access reactive functionalities on non-planar scaffolds. Transformations would then be adopted to multistage flow chemistry allowing streamlined preparation of selective, covalent probes and further biological profiling.
You will be supervised by Mateusz Plesniak, Senior Scientist of Medicinal Chemistry at AstraZeneca. You will also receive academic guidance and mentorship from Daniele Leonori, Professor of Organic Chemistry at RWTH-Aachen University.
You will have the chance to create a high-quality publication. First, this would involve developing synthetic methodology discovered internally to yield reactive functionalities on aliphatic scaffolds and adaptation to the multistage flow chemistry. The second part involves the preparation of the library of chemical probes using the project methodology and application in selective amino acids targeting using MS-based proteomics.
Qualification, Skills & Experience:
Essential Requirements
PhD in Synthetic Organic Chemistry, Medicinal Chemistry, or a related field
Solid background in synthetic organic chemistry, inert atmosphere techniques, purification, and structural elucidation techniques such as NMR
In-depth knowledge and understanding of photoredox catalysis and/or radical chemistry
A solid track record of research, proven by high-impact publications in peer-reviewed journals, patents and/or talks at scientific meetings



Desirable Requirements
Expertise in photoredox catalysis and/or radical chemistry
Basic knowledge of Chemical Biology principles
Knowledge or experience of flow chemistry
Proven track record of problem solving and delivery in organic chemistry/medicinal chemistry
Ability to work independently and in multidisciplinary teams, showing strong levels of collaboration and communication within teams and across departments
Strong passion for chemistry and scientific curiosity



Ready for an exciting, rewarding challenge? Apply today! 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

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? 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

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

Be empowered to be innovative and creative where difference is valued
Join a place built on innovation and creativity where different views and perspectives are welcomed and valued. An environment that champions inclusion and teams that reflect the diversity of the communities we serve.
Follow the science to explore and innovate
Join the team unlocking the power of what science can do. We are working towards treating, preventing, modifying, and even curing some of the world’s most complex diseases. Here we have the potential to grow our pipeline and positively impact the lives of billions of patients around the world.
What you’ll do
The Systems Medicine group is seeking a Modelling and Simulation Specialist passionate about using mathematical and computational skills to develop and apply empirical or mechanistic models of Safety Pharmacology and Toxicology. The group is under the Department of Clinical Pharmacology & Quantitative Pharmacology and consists of mathematical modelers with pharmacy, pharmacometrics, computational biology, biomedical/chemical engineering or statistics backgrounds.
Working in a dynamic, multidisciplinary environment, the successful candidate support projects in both non-clinical and clinical phases. The candidate will develop and apply pharmacokinetics (PK), toxicokinetic (TK), pharmacodynamics (PD), Toxicodynamic (TD) or mechanistic systems models to investigate and translate in vivo safety findings from pre-clinical species into patient populations.
To succeed in this role, we believe you are a person who enjoys working collaboratively with a variety of key stakeholders and collaborators to find opportunities, build support and deliver innovative solutions.
The position will be based at our vibrant R&D site in Gothenburg, Sweden.
Main Duties & Responsibilities
Creating, expanding, or refining mathematical models to address drug discovery and development questions
Reviewing, analysing, and preparing available data for modelling purposes and applying the best modelling approaches to improve project decision-making
Developing and applying PKPD or TKTD models to enable the translation of safety findings from pre-clinical species to humans
Developing and using mathematical models to improve quantitative understanding of toxicity mechanisms based on literature and in-house data. This includes Identifying relevant data (in vitro and in vivo pre-clinical and clinical study data) for model development, optimization, and validation
Influencing experimental design by using available data and appropriate modelling solutions
Continuous collaboration with project teams and presenting modelling work
Contributing to developing and implementing new modelling and simulation strategies for drug safety
Staying up to date with emerging literature in modelling and simulation sciences



Essential Requirements
PhD or similar degree in pharmacy, pharmacometrics, chemical, mechanical, or biomedical engineering, physics, applied mathematics or related field
Excellent understanding of theory, principles and statistical aspects of mathematical modelling and simulation, including numerical methods, parametrization, and ODEs
Hand-on knowledge of modelling with ODEs and Statistical modelling
Programming proficiency and experience with relevant software tools, such as R, Python or MATLAB
Self-directed, independent, and highly motivated researcher who excels in a collaborative, multi-disciplinary environment
Excellent communication skills and the ability to quickly build positive and effective relationships across pre-clinical and clinical safety teams
Ability to learn new areas of biological sciences and build on a proven foundation of quantitative skills to develop models
Ability to keep up to date with and propose the implementation of scientific and technological developments



Desirable Requirements
Industry or postdoctoral experience in building, validating, and using predictive mathematical models (PKPD/TKTD/mechanistic models)
Exposure to current principles and concepts in DMPK, Toxicology and Safety
Experience with PK, PKPD, TKTD modelling and joint longitudinal modelling tools such as Monolix or any other relevant software
Knowledge of models of biological pathways/systems to support translational research
Familiarity with the challenges of drug discovery and forward-thinking concerning the general application of mathematical models in discovery and development
Evidence of identifying, developing, and applying innovative solutions to problems faced in systems and predictive modelling
Scientific leadership, as evidenced by the publication record



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 ignite your entrepreneurial spirit. There’s no better place to make a difference in medicine, patients, and society. A culture that champions diversity and collaboration. Always committed to lifelong learning, growth, and development. 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

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
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

Job description
Clinical Supply Program Lead

Do you have expertise in, and passion for, Supply Chain? Would you like to apply your expertise to make an impact in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!

We have an exciting opportunity for a Clinical Supply Program Lead, depending on your background and experience. This could be an opportunity for development to join our team!

The Clinical Supply Program Lead is a key role accountable for the end to end clinical supply chain of a global programme of products. You will have a specific responsibility for the long-term strategy and will be a strong influencer in its design.

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

Responsibilities
As a key partner working across different organisations, you will represent Clinical Supply & Operations in PT&D and Global project teams, as well as leading a matrix multi-functional team to drive strategy and to manage supply chain performance through key performance indicators. 

You will;
Be responsible for the development and performance of clinical supply chains owning the E2E supply of products in the development portfolio
Lead the Supply Chain Team (SCT) which is accountable for developing and maintaining the supply plan for the project
Work in conjunction with the Supply Chain Planner to balance short to mid-term Supply and Demand, Inventory Management and input into D&OP; Process
Establish development projects to ensure the delivery of the supply of materials, moving from development sources to commercial sources of manufacture
Understand GMP (Good Manufacturing Practice) and the impact it has on supply chain activities
Monitor the performance of the Supply Chain and optimize for higher volume phases of the project, balancing speed, quality and cost with respect to the agreed level of risk
Be accountable for a significant budget for supply activities and materials for a project
Ensure timely delivery of information to meet internal and external regulatory and legal requirements
Manage change in demand and supply, resolve issues, advancing when appropriate


Qualifications
Essential for the role
Extensive experience of working in supply chains
Significant experience of business relationship management
Capability in partnering, influencing and optimising customer requirements
Knowledge of Clinical Supply Chains, drug development process and GMP standards
Awareness of GXP Standards within a Clinical environment
Demand Management and forecasting experience
Strong Project Management, change management and risk management capability


Desirable for the role
Proven technical skills and mindset in supply chain management including demand management, supply chain design, optimisation and delivery
Consistent track record of leading global cross functional teams
Good influencing, negotiating and problem-solving skills, including across functional, geographical and cultural boundaries
Solid understanding of the Clinical Trial Directive and global regulatory environment impacting the provision of investigational products


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!

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 2021-12-01,  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

Biophysical and structural studies of Protein-Oligonucleotide Interactions
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 disease. 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 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.
You’ll be empowered and supported to drive the success of your project, publish papers, achieve your goals and make 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 cutting edge research laboratories and organization.
About the Opportunity
Working from our vibrant Gothenburg site in Sweden, you will have the critical task of developing biophysical assays to study intracellular proteins and oligonucleotides/RNA interactions (particularly antisense oligos, ASOs). Through biophysical technologies such as SPR, ITC, DSF and SMM, you will significantly impact current oligonucleotide projects since you will provide insights on the correlations between ASOs chemistry and efficacy in biological systems.
As an expert in RNA biophysics, you will utilise your expertise in assay development, propose experimental strategies and troubleshoot challenges to succeed in your role. You will also be involved in protein production and oligonucleotide design in close collaboration with the team and other groups at AstraZeneca. This work will be fundamental to uncover ASOs mechanism of action and provide crucial insights for developing new oligonucleotide-based therapeutics.
You will apply biophysical techniques such as SPR, ITC, DSF and SMM and develop novel assays specific to RNA targets. Actively investigate and propose proteins that could be of interest by affecting the efficacy of oligonucleotides in response to chemical modifications. Based on preliminary studies and your observation, you will design and label new oligonucleotide and RNA probes.
You will join the Mechanistic and Structural Biology team at AstraZeneca with extensive experience in measuring molecular interactions, and work in collaboration with leading external experts in oligonucleotides-based therapeutics. You will be an essential member within a growing and diverse postdocs team, working on oligonucleotides-based therapeutics, thereby creating yourself unique opportunities for collaboration and learning.
This position offers the opportunity to be creative in a field of Oligonucleotide Therapeutics that is nowadays groundbreaking. The wide window of exploration and the active collaboration with multiple experts across AstraZeneca functions will provide an outstanding opportunity to apply biophysical techniques both in vitro and in cells. This strong network of experts will help to ensure a high impact publication track record. Therefore, the programme offers the ability to maintain a driven research output.
Qualification, Skills & Experience
Required:
PhD or postdoc in RNA structure and biophysics
Sophisticated and up to date knowledge in RNA modalities and Biophysical technologies
Experience in RNA biology assays
Passion for exploring innovative ways to bringing big data together in biologically meaningful ways

Desirable:
Knowledge in the area of Oligonucleotide Therapeutics, including design and synthesis
Hands-on experience in Cellular Assays
Scientific excellence as shown by previous work, publication list or references from scientific mentors?

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

Of how membrane fluidity (MF) can affect nanoparticle (NP) processing and performance and how nanomedicines might be optimised accordingly
AstraZeneca is a global, science-led, patient-centred biopharmaceutical company that focuses on discovering, developing, and commercialising 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 tackle 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.
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 organisation.
About the Opportunity
Our postdoc program is well-established and full of dedicated scientists that form an active and very collaborative community. From AstraZeneca's largest R&D site in Gothenburg, you will gain direct experience in the pharmaceutical industry and pursue your research in pioneering laboratories.
We would like you to do experimental science, make discoveries, and have fun doing it. You will have the support of a leading academic advisor, Professor Marc Pilon, with deep knowledge of membrane fluidity, who'll help provide you with the mentorship and expertise you need to develop your career. As well as Dr. Alan Sabirsh, Principal Scientist, Advanced Drug Delivery at AstraZeneca, who knows the lab systems well and has extensive experience working with successful postdoc projects. You will be joining a team that has benefitted from a series of postdoc projects. Much of the infrastructure is well-established, and many of our previous postdocs can collaborate, as they are now permanent employees. We have tried to reduce the risk associated with the project by generating preliminary data and designing the project to align with previous or ongoing work.
This is an exciting area that hasn't been explored to its full potential. Yet, it is also a very hot topic within the biotech sector, making this a chance to create a real difference to the future of medical science and your career!
Qualification, Skills & Experience
Required:
PhD degree with a specialisation in cell biology, biotechnology or, equivalent scientific field
Extensive experience with in-vitro cell culture and cell biological methods
Experience with molecular biological methods and genetic manipulation
Good knowledge of endocytosis, intracellular trafficking pathways and relevant intracellular signalling
Experience with advanced microscopy, laboratory automation, high-content biology (robotic microscopy and image analysis; Columbus, MatLab, ImageJ and/or Cell Profiler), gene editing technologies and transcriptomic methods are attractive skills. Candidates will have a high technical competence and demonstrate experience in most or all of these areas
Proven track record to drive innovative research through internalisation of new techniques and technology and forming internal and external collaborations
Track record of scientific excellence, with a strong publication record and engagement with the scientific community through conferences and collaborations. An ability to independently build finished manuscripts will be vital
Desirable:
Experience with robust assay development, including multivariate data analysis, processing and visualisation and, statistical tools for factorial experimental design
Experience with drug delivery technologies for the intracellular delivery of macromolecules, such as lipid nanoparticles
The project will potentially involve disease models of Huntington's disease, cancer and diabetes/obesity, so experience in these areas is desirable
Excellent communication skills in English (written and spoken)
Supervisory skills and experience (for opportunities involving students and more junior personnel)
Are you already imagining yourself joining our team? Good, because we can't wait to hear from you.
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 improve metabolic function via enzyme supplementation gene therapy
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 disease. 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 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.
You’ll be empowered and supported to drive the success of your project, publish papers, achieve your goals and make 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 cutting edge research laboratories and organization.
About the Opportunity
Your project will focus on designing and developing a next generation gene therapy modality targeting genetic disorders using Phenylketonuria (PKU) as a proof-of concept. PKU is a rare inherited disorder that in which the amino acid phenylalanine builds up in the body, caused by loss-of function mutations in the phenylalanine hydroxylase (PAH) gene.
You will explore different strategies for in vivo delivery of the PAH enzyme using genome engineering and gene delivery technologies. Treatment concepts will be interrogated and validated in human stem cell based in vitro systems to optimize their therapeutic potential.
In your daily work you will be responsible for designing and performing experiments such as cell-based in vitro assays, designing chimeric protein constructs, assessment of enzyme function in vitro and in disease relevant in vivo models. Independently, you will assess and present data to support project progression and publication.
You will be working at the cutting edge of cell and gene therapy technologies to design and develop a treatment strategy for unmet clinical need. Your scientific findings will have a significant impact on biopharmaceutical development processes and platforms that are sought at improving patient experience and convenience in using life-saving medicines. While making a significant contribution to bringing better medicines to life, you will also have the opportunity to showcase your work at prestigious scientific conference and in high impact peer-reviewed journals. Collaborating with brilliant colleagues from across AstraZeneca's groundbreaking R&D facilities, your passion and drive will accelerate the project.
Qualification, Skills & Experience
Required:
PhD in Medicine, Hematology, Cell Biology, Biochemistry, or Molecular Biology
Expertise in mouse models and in vivo work, ideally with a knowledge of in vivo models relevant to hematology
Experience with basic molecular biology techniques, such as PCR, immunodetection, etc.
Understanding of basic genetic engineering techniques
Demonstrated experience of publishing scientific papers in peer reviewed journals
Ability to work independently, take own initiatives and have positive, goal oriented and problem solving attitude
Excellent communication skills and interpersonal skills, with a collaborative mindset

Desirable:
Experience with biochemistry and enzyme activity assays
Experience in stem cell culture and differentiation
Knowledge of hematopoiesis and hands-on in vitro culture experience of hematopoietic stem cells or other relevant cell types
In vivo nucleic acid delivery and gene modification experience
Keen interest in gene and cell therapy development
Good organizational, data management and documentation skills

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

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

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

Job description
AstraZeneca (AZ) is developing a vaccine to target Covid-19. As part of this effort, the Biologics Global Technical Operations (GTO) group is working with AZ colleagues in R&D to enable the technology transfer of the drug substance (DS) and drug product (DP) manufacturing process to multiple large scale external manufacturing partners (CMOs) to enable rapid scale-up, process qualification and commercial manufacture.

We are looking to augment the GTO team working on technology transfers with a DS / DP Tech Transfer Engineer. In this role, you will also work with GTO Drug Substance and/or Drug Product technical stewards, R&D process development and quality experts within AstraZeneca and partner CMO sites to support ongoing technology transfers and process performance qualification at the CMO. You will be expected to stay on the program for a minimum of 6 months and up to 12 months. This is a consulting position at AstraZeneca.

To succeed in this role, you will need to be self-motivated, well organized, have strong technical and communication skills, and a solid understanding and hands-on experience of biologics DS and/or DP manufacturing and quality/compliance requirements.

The position provides the opportunity to work with a highly motivated and talented global team, working under aggressive timelines to deliver a cutting edge monoclonal antibody manufacturing process to multiple world-class manufacturing facilities and support AZ’s efforts in dealing with the Covid-19 pandemic.

Responsibilities
Work with Drug Substance/Drug Product Technical Stewards and SMEs from R&D, Quality, Validation with AZ and external partner sites to support technology transfer of drug substance processes (upstream and downstream) to external manufacturing sites.
Support drafting, review and approval of tech transfer and manufacturing documentation such as risk assessments, gap analyses, batch records, standard operating procedures and sample plans.
Serve as Manufacturing /Technical point of contact on specific workstreams/sub-projects, attending teleconferences with CMOS and internal teams, following up with stakeholders on action items etc.
Update project dashboards/presentations with project status to provide timely communication of status to internal team. Proactively identify risks, and develop / implement work plans to manage / mitigate / communicate risk to senior technical transfer leads.
Work with CMOs to compile and trend DS/DP manufacturing process data during manufacturing campaigns.
Note: The AZ team will be based in the US East Coast, CMOs receiving technology transfers are located in EU, and Far East. Will require ability to work flexible hours to support multiple global time zones.


Qualifications
Minimum Requirements:

Education/Experience
Degree in an engineering or scientific discipline with experience in biopharmaceutical Manufacturing Science& Technology/ Manufacturing/ Process Engineering/ Quality. Prior experience in Drug Substance tech transfers preferred.

B.S with 10+ years of experience
M.S. with 6+ years of experience
PhD with 4+ years of experience

Knowledge/Skills
Strong knowledge of biologics manufacturing operations and equipment, with prior experience in Manufacturing, Technical Operations, MFG Science and Technology, or Quality.
Ability to work on multiple projects and meet deadlines as needed; emphasis on results-oriented, strong planning and execution skills.
Strong communication skills, with the ability to collaborate in cross functional teams across multiple organizations
Ability to work in a complex, dynamic, global environment.

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
2021-06-03, 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: Sara Kuikka [email protected] or Eleonor Ehrman +46733434109

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 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
Would you like to use your clinical project management experience to help deliver life changing medicines to patients? If you would please read on!

At AstraZeneca; Be empowered to be innovative and creative where difference is valued. Join a place built on innovation and creativity. Where different views and perspectives are welcomed and valued. An environment that champions inclusion, and teams that reflect the diversity of the communities that we serve.

We’re currently looking for Clinical Sample Project Managers (Compound Leads) to join a dynamic Biosamples team based. This is a consulting position at AstraZeneca in Gothenburg.

Responsibilities
In this role, you will project manage the delivery of laboratory related activities in both early and late phase global development projects. We’ll look to you to work independently with the clinical project teams and our global external laboratory partners / alliances to ensure operational delivery of the clinical laboratory testing of biological samples, the efficient deployment of tests (including biomarkers, central safety and clinical bioanalysis), as well as data generation and delivery throughout the project lifecycle.

This is a fantastic opportunity to progress your career in clinical development and to play a key role in the development of an exciting portfolio of medicines that will change the lives of patients worldwide.

Your position will be varied and include the responsibility for ensuring the delivery of all laboratory activities through external partners, meet internal and external quality and regulatory standards all whilst using your operational expertise to advise clinical teams on operational lab strategy, development and deployment. You will regularly be involved in providing advice to clinical teams on laboratory related documentation, operational design and new ways of working, as well as managing external providers to oversee the delivery of relevant lab services and data.

Qualifications
We are looking for a candidate that have experience in some or all of the following.
Experience of contributing to the operational deployment of clinical laboratory testing on global clinical development projects.
Project Management skills to provide operational expertise and guidance to the multiple internal and external parties involved in a clinical project, and a proven record in overseeing external partners, especially multidisciplinary clinical laboratory service providers.
Influencing skills and experience of negotiations
A solid knowledge of early or late stage clinical development, as well as an understanding of GCP and GCLP.

Suitable candidates may have a science background and would like to extend their knowledge to clinical study operations (degree educated preferable, but not essential) or have backgrounds including laboratory project management, investigator site coordination or study operations. In addition to this, the following experiences are also desirable;
Experience of working collaboratively with external vendors in partnerships or alliances
Experience of working in more than one company or country multi-nationally
Hands-on experience in a clinical laboratory setting or clinical research site
Project management experience

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
2021-05-20, 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 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 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

AstraZeneca is a global Biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines for some of the world's most serious diseases. But we are more than just one of the world's leading pharmaceutical companies. At AstraZeneca, we're proud to have a unique workplace culture that encourages innovation and partnership through scientific research. Employees are empowered to express different perspectives and are made to feel valued, energized and rewarded for their ideas and creativity.
Main Duties and Responsibilities
The Respiratory & Immunology Translational Science and Experimental Medicine department is a fast-paced environment, 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 target and the right patient population, and to close the gap between bench science and bedside clinical practice.
A key role of Precision Medicine Discovery Immunology is to lead the development of precision medicine in Immunology diseases, driving patient segmentation and delivering translational clinical validation underpinned by the understanding of disease relevant pathways and drivers.
The Translational Science Lead (TSL) Immunology is a key scientific and strategic role where you will be focusing on:
delivering precision medicine strategies to select the patients most likely to benefit from our medicines in early/late clinical studies
building mechanistic understanding of the target and disease through innovative application of experimental methods and technologies
building the translational clinical validation package for Immunology targets and utilising public and proprietary biobanks, to better understand responding sub populations, biomarkers and the biology of our drug targets
identifying and enabling Proof of Mechanism (PoM) biomarkers to demonstrate target engagement at First-In-Human (FIH)

The TSL is accountable as a member of a project team for the precision medicine strategy and clinical target validation strategy. Continuously collaborating with functions within and outside Early Respiratory and Immunology will be crucial to strengthen the link between targets and disease phenotypes and endotypes and bring precision medicine propositions to the clinic and subsequently to market. The TSL is both a laboratory and project role, requiring flexibility to ensure all translational aspects of the projects are supported according to timelines.
This is a high-profile role requiring an individual with outstanding communication and leadership skills. Vital to this role is the ability to build collaborations in biosciences, clinical development, clinical biostatistics, bioinformatics/data sciences and other functions within AstraZeneca and to work effectively with external vendors and academic collaborators.
The individual must be a strong scientific and strategic leader who can work within a fast-paced organization. Publication of manuscripts in top-tier scientific, technical or medical journals is encouraged, thereby contributing to AstraZeneca’s scientific leadership.
Qualifications & Skills
Understanding of immunology, autoimmunity and/or inflammatory therapy areas and disease biology, including related molecular pathways and mechanisms
Experience and knowledge of the biological basis for target engagement biomarkers and familiar with PoM biomarker development and implementation
Experience and knowledge of the biological basis for patient segmentation, precision medicine and familiar with patient selection biomarker development and implementation
Experience in the development and execution of biomarker and precision medicine strategies as part of clinical studies
Broad understanding of relevant technologies and methodologies along with excellent scientific laboratory skills and ability to experimentally address key scientific questions
Ability to assess vendor options for collection of data sets and to secure delivery of these data sets
A record of innovative contributions to translational research in immunology, inflammatory and/or autoimmune diseases, as evidenced by a publication record, inventorship on patents/filings and/or presentations at major conferences
Exceptional organizational skills with attention to detail; proven project management skills
Outstanding verbal and written communication skills; ability to write technical reports and to present sophisticated data
Strong leadership and collaboration skills to work and lead in a matrix environment which includes research, clinical development and commercial functions

Education/Experience
PhD or equivalent with a strong experimental drive and background in relevant scientific field
A minimum of 5 years post-doc experience
Experience in an industry setting (desirable) Visa mindre

Job description
Working with the PV Processes leads and Process Principals, supporting tasks related to management of AstraZeneca projects, processes including implementation, communication, quality, compliance, tracking, performance and inspection readiness. Accountable to develop relationships across Patient Safety and other relevant areas of AZ to execute the delivery of the assigned tasks in relation to processes strategy, priorities, alongside governance and management of the current procedural documents. This is a consulting assignment at AstraZeneca in Gothenburg.

Responsibilities
Collaborate with PV Process Leads and Principals with support the enhancement of existing processes
Working with the Process leads and Principals, and Patient Safety and Regulatory experts, develop, establish, monitor, report and assess global KPIs related to safety and regulatory data reporting.
Support PS Process owners with guidance, advice and support on PD process.
Author and collaborate with SMEs to deliver assigned Toolkit documents and templates.
Maintain and continuously improve key customer facing service solutions for Process guidance and document access (R&D Process Portal, Lollipop, PSDM SPOL, Q&A ticket portal etc).
Coordinate specific tasks related to procedural document management to provide oversight to the Pharmacovigilance (and PS) process team
Using understanding of PV and Regulatory processes and regulations to provide support to regulatory process team
Promote a culture of continuous improvement, high performance, flexibility and quality emphasising a “can do” attitude and innovative approaches.
Identify opportunities to improve and simplify the methodology in processes and guidance, provide practical solutions and drive to implementation.
Support and improve reporting tools and analysis processes and process metric /KPI data. Performing the monitoring, analysis and trending of data in own area of work.
Identify issues and risks in own area of work and propose options to mitigate them.
Ensure that appropriate, up-to-date records are maintained for compliance
support activities for GVP, GCP, GRP and GMP audits/inspections
Support Delivery of improvement project assignments supporting the business,
Provide process training to relevant functional groups or support preparation of training material.
Seek personal and professional development opportunities, and share knowledge gained in open forums
Contribute to communication and change management activities associated with process initiatives.
Building relationships with stakeholders and customers to support pharmacovigilance and regulatory activities and responsibilities including successful partnerships
Working collaboratively to provide expertise and sharing best practices across all regions and in all partnerships


Qualifications
A science/pharmacy/nursing degree,
Experience in working cross-functionally
Administrative skills including Sharepoint online expertise
Project Management skills
Good attention to detail
Excellent written and verbal communication skills
Proven ability to work across cultures

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
2021-05-05, 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 +46733434153

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 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
Would you like to use your clinical project management experience to help deliver life changing medicines to patients? If you would please read on!

Responsibilities
At AstraZeneca Be empowered to be innovative and creative where difference is valued. Join a place built on innovation and creativity. Where different views and perspectives are welcomed and valued. An environment that champions inclusion, and teams that reflect the diversity of the communities that we serve.

We’re currently looking for Clinical Sample Project Managers (Compound Leads) to join a dynamic Biosamples team. This is a consulting position at AstraZeneca in Gothenburg.

In this role, you will project manage the delivery of laboratory related activities in both early and late phase global development projects. We’ll look to you to work independently with the clinical project teams and our global external laboratory partners / alliances to ensure operational delivery of the clinical laboratory testing of biological samples, the efficient deployment of tests (including biomarkers, central safety and clinical bioanalysis), as well as data generation and delivery throughout the project lifecycle.

This is a fantastic opportunity to progress your career in clinical development and to play a key role in the development of an exciting portfolio of medicines that will change the lives of patients worldwide.

Your position will be varied and include the responsibility for ensuring the delivery of all laboratory activities through external partners, meet internal and external quality and regulatory standards all whilst using your operational expertise to advise clinical teams on operational lab strategy, development and deployment. You will regularly be involved in providing advice to clinical teams on laboratory related documentation, operational design and new ways of working, as well as managing external providers to oversee the delivery of relevant lab services and data.

Qualifications
We are looking for a candidate that have experience in some or all of the following:
Experience of contributing to the operational deployment of clinical laboratory testing on global clinical development projects.
Project Management skills to provide operational expertise and guidance to the multiple internal and external parties involved in a clinical project, and a proven record in overseeing external partners, especially multidisciplinary clinical laboratory service providers.
Influencing skills and experience of negotiations
A solid knowledge of early or late stage clinical development, as well as an understanding of GCP and GCLP.


Suitable candidates may have a science background and would like to extend their knowledge to clinical study operations (degree educated preferable, but not essential) or have backgrounds including laboratory project management, investigator site coordination or study operations.

In addition to this, the following experiences are also desirable;
Experience of working collaboratively with external vendors in partnerships or alliances
Experience of working in more than one company or country multi-nationally
Hands-on experience in a clinical laboratory setting or clinical research site
Project management experience

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
2021-04-14, 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 Linnea Öster [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 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
AstraZeneca (AZ) is developing a vaccine to target Covid-19. As part of this effort, the Biologics Global Technical Operations (GTO) group is working with AZ colleagues in R&D to enable the technology transfer of the drug substance (DS) and drug product (DP) manufacturing process to multiple large scale external manufacturing partners (CMOs) to enable rapid scale-up, process qualification and commercial manufacture.

We are looking to augment the GTO team working on technology transfers with a DS / DP Tech Transfer Engineer. In this role, you will also work with GTO Drug Substance and/or Drug Product technical stewards, R&D process development and quality experts within AstraZeneca and partner CMO sites to support ongoing technology transfers and process performance qualification at the CMO. You will be expected to stay on the program for a minimum of 6 months and up to 12 months.

Responsibilities
To succeed in this role, you will need to be self-motivated, well organized, have strong technical and communication skills, and a solid understanding and hands-on experience of biologics DS and/or DP manufacturing and quality/compliance requirements.

The position provides the opportunity to work with a highly motivated and talented global team, working under aggressive timelines to deliver a cutting edge monoclonal antibody manufacturing process to multiple world-class manufacturing facilities and support AZ’s efforts in dealing with the Covid-19 pandemic.

Essential Job Functions:
Work with Drug Substance/Drug Product Technical Stewards and SMEs from R&D, Quality, Validation with AZ and external partner sites to support technology transfer of drug substance processes (upstream and downstream) to external manufacturing sites.
Support drafting, review and approval of tech transfer and manufacturing documentation such as risk assessments, gap analyses, batch records, standard operating procedures and sample plans.
Serve as Manufacturing /Technical point of contact on specific workstreams/sub-projects, attending teleconferences with CMOS and internal teams, following up with stakeholders on action items etc.
Update project dashboards/presentations with project status to provide timely communication of status to internal team. Proactively identify risks, and develop / implement work plans to manage / mitigate / communicate risk to senior technical transfer leads.
Work with CMOs to compile and trend DS/DP manufacturing process data during manufacturing campaigns.
Note: The AZ team will be based in the US East Coast, CMOs receiving technology transfers are located in EU, and Far East. Will require ability to work flexible hours to support multiple global time zones.


Qualifications
Minimum Requirements:

Education/Experience
Degree in an engineering or scientific discipline with experience in biopharmaceutical Manufacturing Science& Technology/ Manufacturing/ Process Engineering/ Quality. Prior experience in Drug Substance tech transfers preferred.

B.S with 10+ years of experience
M.S. with 6+ years of experience
PhD with 4+ years of experience

Knowledge/Skills
Strong knowledge of biologics manufacturing operations and equipment, with prior experience in Manufacturing, Technical Operations, MFG Science and Technology, or Quality.
Ability to work on multiple projects and meet deadlines as needed; emphasis on results-oriented, strong planning and execution skills
Strong communication skills, with the ability to collaborate in cross functional teams across multiple organizations
Ability to work in a complex, dynamic, global environment

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
2021-04-11, 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 Sara Kuikka [email protected] or Eleonor Ehrman +46733434109

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 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

Cell engineering to generate models for BioPharma drug discovery

Hays Specialist Recruitment is now looking to recruit a Senior Research Scientist - cell engineering to generate models for BioPharma drug discovery for a 1-year contract assignment at AstraZeneca in Gothenburg.

Are you a curious scientist with expertise in cellular engineering and a passion for cell model generation? Would you like to apply these skills to impact early drug discovery in a company that follows the science and turns ideas into life changing medicines for patients worldwide? Then AstraZeneca might be the place for you!

As a Senior Research Scientist in Gothenburg, Sweden, you'll play a pivotal role in channelling our scientific capabilities to make a positive impact on changing patients' lives. As a part of the Discovery Biology Department in the Cellular Biology Team you will be developing bespoke cellular models using a wide range of cell engineering tools including the Nobel-winning CRISPR/Cas system. These cellular models will feed into our drug discovery pipeline supporting target validation, screening assays, and detailed biological mechanism-of-action studies.

You will work within Discovery Sciences, part of AstraZeneca's BioPharmaceuticals organisation, which focuses on scientific advances in established and emerging medicine formats and drug discovery technologies across therapeutic areas including Respiratory & Inflammation (R&I), Cardiovascular, Renal & Metabolism (CVRM), and Neuroscience.

What you will do:
Specifically, the successful candidate will take a lead scientific role in applying their cellular engineering skills to design, generate, validate and characterise cellular models to progress drug discovery. You will provide expertise in genome engineering across a range of cell types, coupled to validation of the models at DNA, RNA and functional protein levels.

It is a lab-based position where you will utilise your expertise in cellular model generation through genome engineering to independently design, develop and validate models for implementation in drug discovery projects, while incorporating the views of others. In addition, you will employ cutting-edge cell biology to drive scientific development in the field.

The position also includes:

* Design and implementation of work-plans to agreed timelines to meet project objectives, including delivery of more than one agreed area of work in parallel
* Be an effective member of Drug Discovery Project Teams, contributing novel ideas and using judgement and knowledge to influence the work of the project
* Achieve personal scientific visibility through project contributions and internal presentations at departmental or functional meetings; and external scientific visibility through poster and oral conference presentations and authorship on peer-reviewed publications

Essentials for the role:

* PhD in Biology, Pharmacology, Cell Biology or a related discipline or an MSc degree with significant relevant experience, preferably in the pharmaceutical or biotechnology industry
* Expertise in cellular genome engineering from demonstrable design and tool generation through to validation and functional characterisation
* Strong experience in appropriate cellular biology techniques applied to development of physiologically relevant cellular assays (endogenous gene-tagging, gene expression knock-down, transfection methods)

Desirable for the role:

* Experience in imaging (light microscopy) techniques for cell model validation and imaging assay development
* Experience in flow cytometry including FACS for selection of single cell clones through flow
* Good publication records in peer-reviewed journals demonstrating engineering expertise
* Excellent problem-solving skills, strong delivery focus and communication skills. Effective team worker with experience of interacting effectively across interfaces of discipline, culture, and expertise
* Research experience in R&I, CVRM and/or Neuroscience diseases Visa mindre

Stem & Primary Cell Team in Discovery Sciences

Hays Specialist Recruitment is now looking for a Senior Research Scientist - Rare Disease Biology/Gene editing to join the Stem & Primary Cell Team for a 1-year contract assignment at AstraZeneca in Gothenburg.

Are you an experienced scientist in the field of stem cells and gene editing? Would you like to combine your scientific skills & drive the development of gene-editing based therapies?
This might be the next challenge for you!

At AstraZeneca in Gothenburg, Sweden we have an exciting opportunity for you to join us in the Stem & Primary Cell Team in Discovery Sciences, Biopharmaceuticals R&D, as a bench-based Senior Research Scientist to be a key player in developing therapeutics to change patients' lives.

The role
You will be based in Gothenburg Sweden, working alongside our stem cell scientists, disease area specialists and genome editing group. Using your strong knowledge and experience in stem cell biology, cell model development and CRISPR technology you will have the opportunity to work on in vitro validation aspects of a therapeutic gene editing project. This includes culture and differentiation of induced pluripotent stem cells (iPSCs) and carrying out gene editing experiments to validate target hypothesis. This position is for one year in the first instance.

The role is focused on laboratory-based activities. Your biggest impact will be through significant contributions to the practical delivery to projects in compliance with AstraZeneca corporate responsibility, policies and relevant safety standards.

It is essential to have good social and communication skills, be collaborative and a strong team player. Candidates should be able to work independently, take own initiatives and have a positive, goal oriented and problem-solving attitude.

Good organizational, data management and documentation skills are required, and you should be comfortable in presenting your results. English language is required, both spoken and in writing.

Key Responsibilities:

* Culture and differentiate hPSC lines to skeletal and cardiac muscle.
* Culture human primary cells and various mammalian cell lines.
* Perform in vitro and ex vivo studies to investigate the effects of CRISPR-based gene editing on gene and protein expression, cellular readouts and muscle function.
* Perform molecular biology protocols in support of in-house quantitative PCR, digital PCR and NGS assays.
* Effectively collaborate within a matrixed research team to facilitate the success of projects. Maintain complete experimental records.

Minimum Requirements:

* PhD in Developmental Biology, Cell Biology, Gene Editing or a BSc/MSc degree with significant experience
* Proven experience with PSC biology and directed-differentiation to skeletal and cardiac muscle
* Experience with the culture of multiple mammalian cell types including primary cells
* Hands-on experience with the following assay platforms: RT-qPCR, ddPCR, SDS-PAGE, ELISA, Western blots, Flow cytometry and/or cell- based functional/ potency assays.
* Excellent communication skills with ability to build open and collaborative relationships and work effectively as a member of a multidisciplinary team.
* Excellent organizational skills and documentation practices.

The following skills are highly desirable:

* Experience with CRISPR gene editing and NGS library prep
* Expertise with liquid handling automation technologies
* Experience of setting up cell based pharmacological assays Visa mindre

Do you have expertise in, and passion for, quantum chemistry and quantum computers? Would you like to apply your expertise to expand the applicability of current state of the art hardware to demonstrate potential quantum advantage in real-world chemistry problems? Then AstraZeneca might be of interest to you!
Pharmaceutical Sciences at AstraZeneca is a member of Next ApplicationS of Quantum Computing (NEASQC) a European Union Quantum Flagship funded program. We will develop and implement novel quantum chemistry algorithms to explore quantum effects on chemical reactivity. As part of this program we are looking for a Postdoc in Quantum Computing. This is a fixed term position for two years in Pharmaceutical Sciences, BioPharmaceutical R&D Gothenburg, Sweden.
What’s in it for you? You will get the opportunity to engage with key internal and external stakeholders to identify and validate impactful solutions to provide scientific leadership and drive innovation in applied quantum computing. You will simply be at the forefront of the quantum revolution within AstraZeneca turning ideas into life changing medicines for patients!
Who are you? We think that you who will accept the challenge have a PhD in quantum chemistry. You have strong knowledge about quantum computers and a strong track record of programming with experience of quantum simulation packages like QISKIT. At AstraZeneca you will fit right in if you thrive on team work, networking, communication and the ability to influence both people and science.
Would you like some more details about the role before applying? As a Postdoc you will be part of the Data Science and Modelling department. The department is responsible for developing data science and artificial intelligence (AI) methods to accelerate the digital transformation of the Pharmaceutical Sciences research unit. Your main responsibility will be to ensure the AstraZeneca deliverables to the NEASQC program. Visa mindre

Location: Gothenburg, (Sweden)
Salary: Competitive, with excellent benefits package
If you have a science based bachelor’s or master’s degree and a desire to explore your scientific potential within a global biopharmaceutical organisation, our 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.
What does the programme involve?
Starting in September 2021, 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 within chemistry, molecular biology, biochemistry, pharmacology amongst other scientific areas. As well as helping you broaden your scientific knowledge, we’ll help you develop ‘soft’ skills required to fulfil your career potential.
You will gain an invaluable blend of on-the-job experience and coaching. You’ll enjoy guidance and advice from a huge support network, including a mentor and dedicated programme manager. 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!
Essential requirements
A 2:1 (UK) / GPA 3 (US) / VG Grade (Sweden) or local equivalent Bachelor’s degree, or a Master’s level qualification, in any life science or chemistry related subject awarded in 2020 or due to be awarded in 2021.
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.

Together, we push the boundaries of science to deliver life-changing medicines to patients around the world!
Our virtual assessment events will be held on week commencing the 22nd March 2021.
Applications open: 14th September 2020
Applications close: 24th January 2021 Visa mindre

PhD project title: Patient population stratification towards personalized treatment discovery for Chronic Kidney Disease
AstraZeneca R&D, Gothenburg, Sweden will be the Host institution for this PhD position.
Generic presentation of TrainCKDis:
The TrainCKDis project is an EU-funded initiative to foster and train early stage researchers to better understand and tackle the challenges related to chronic kidney disease (CKD) and improving patients’ lives. TrainCKDis will provide an innovative, multidisciplinary, and intersectoral training programme, able to prepare top-level young scientists to develop creative solutions for CKD. The proposed 15 research projects will address key challenges: i) the identification of genetic and epigenetic modifiers that predispose patients to CKD progression, ii) the identification of pathways and biomarkers for monitoring CKD progression and iii) the identification of novel therapeutic targets to improve the limited treatments for CKD. TrainCKDis gathers top European laboratories, companies, hospitals, and associations involved in the treatment of CKD. Early Stage Researchers will thus benefit from an outstanding interdisciplinary platform integrating nephrology, epidemiology, genetics, cell biology, high-throughput screening, system biology, and metabolomics experts.
Objectives/Description of PhD programme:
Chronic Kidney Disease is highly complex and heterogeneous and includes a wide range of etiologies with a multitude of underlying molecular processes in the kidney. Furthermore, the kidney tissue is structurally heterogeneous and comprised of more than 25 different cell types. These factors make development of treatments for CKD very challenging.
This exciting PhD project will use human omics data and advanced data analysis algorithms to group patients into subtypes and characterize underlying biological pathways in the cell type-specific context that will advance our biological understanding of CKD and open new opportunities for drug discovery leading to personalized treatments.
The successful candidate will conduct bioinformatics analyses of omics (transcriptomics, proteomics, metabolomics) data as well as perform wet-lab experiments to functionally characterize and validate the findings, and will develop a unique combination of both computational and experimental skills. In addition to their individual scientific project, they will benefit from further continuing education, which includes scientific and transferable skills courses, participation in workshops and conferences, and secondments to partner labs.
The successful candidate will be hired for 3 years, full time, and enrolled in the PhD Program of Charité – Universitätsmedizin Berlin graduate school upon meeting the qualifications of admission.
Advantages: As EU-funded project, TrainCKDis offer attractive salary to recruited researchers. To find more details, please read the information note of the European Commission.
Eligibility:
1. To be eligible for recruitment, you must – at the date of recruitment – be within the first four years (full-time equivalent research experience) of your research career and not have a doctoral degree. Full-time equivalent research experience is measured from the date when you obtained the degree entitling you to embark on a doctorate (either in the country in which the degree was obtained, or in the country in which you are recruited), even if a doctorate was never started or envisaged. You may therefore be required to provide documentation proving your eligibility for recruitment.
2.You must not have resided or carried out your main activity (e.g. work, studies) in the country where you apply for more than 12 months in the 3 years immediately before your recruitment date. Holidays are not counted.
TrainCKDis project has received funding from the European Union’s Horizon 2020 research and
innovation programme under the Marie Sk?odowska-Curie grant agreement N°860977.
Essential Requirements
Master’s Degree or equivalent in biomedical (Medical, Biological, Pharmaceutical sciences, Molecular Biology) or quantitative disciplines (Bioinformatics, Biostatistics, Computational Biology, Epidemiology)
Excellent written and spoken English
Strong communication and collaboration skills
Scientific curiosity, creativity, motivation

Desirable Requirements
Working knowledge of kidney biology and disease
Experience in omics data analysis, biostatistics, machine learning, R coding
Peer-reviewed publications



Additional information
The Marie Sk?odowska-Curie Actions offer attractive salary and working conditions. The successful candidates will receive a salary in accordance with the national legislation of the recruiting institution and the Marie Sk?odowska-Curie Actions regulations for early stage researchers. Exact salary will be confirmed upon appointment.
In addition to their individual scientific projects, all ESR will benefit from further continuing education, which includes scientific skills courses, transferable skills courses, as well as active participation in workshops and conferences and secondments to partner labs.
Each ESR will be hired for 3 years, full time.
The European IMGENE training network wish to reflect the diversity of society and welcome applications from all qualified candidates regardless of age, disability, gender, nationality, race, religion or sexual orientation. Visa mindre

Job Description
Are you an in vitro DMPK scientist with expertise in Absorption, Distribution, Metabolism and Elimination (ADME) of oligonucleotides? Would you like to apply your expertise in a 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 committed to the development of next generation innovative medicines and are currently building a cross-functional oligonucleotide capability for the treatment of diseases across therapy areas.
As part of the expansion within the therapeutic oligonucleotides area, we are now recruiting a senior in vitro ADME scientist to join the Drug, Metabolism and Pharmacokinetics (DMPK) department within Research and Early Development Cardiovascular, Renal and Metabolism (CVRM). The position is placed at AstraZeneca’s dynamic R&D site in Gothenburg, Sweden.
CVRM is one of the three main therapeutic research areas within AstraZeneca which deliver candidate drugs into clinical development. CVRM DMPK interacts with other functions in supporting CVRM projects along the value chain, from target selection all the way to launch and life cycle management. We hope that you will be the one to help us increase our capability regarding ADME and Bioanalysis of oligonucleotide therapeutics!
What you’ll do
As a senior in vitro ADME scientist you will be part of a team at the forefront of DMPK science working with all aspects of drug disposition, from whole body, tissues to subcellular drug handling, and relating exposure to drug effects. We are accountable for the breadth of the CVRM drug portfolio, and this role will enhance our team in the area of oligonucleotide therapeutics. You will have the opportunity to contribute to the discovery of new life changing medicines for patients and demonstrate and witness what science can do. Responsibilities include:
Be responsible for designing, conducting, interpret and reporting of in vitro ADME studies for nucleotide drugs. You will apply state of the art in-vitro DMPK science, including the use of 3D-cell cultures, across drug discovery and development to support design and project progression.
Provide scientific leadership by leading and driving collaborations with key academic centers and by presenting work through lectures and publications in top-tier scientific journals.
Identify improvements in technologies that can be successfully applied to a highly competitive drug discovery or development paradigm that contributes to achievement of short and long term business goals and influences strategic direction.
May be part of cross-functional work-streams and lead the development and implementation of DMPK scientific strategies, and act as a catalyst for scientific debate within the AstraZeneca science community

Essential for the role
PhD or equivalent in relevant discipline, and at least three years of experience relevant to the position
Background in Pharmacy, Biology, Biochemistry, Medical Biosciences or similar relevant discipline.
Versatile in in vitro laboratory skills (e.g. handling and culturing of primary human hepatocytes and other human cells and tissues, molecular biology methods and image analysis, enzyme and transporter kinetic studies)
Broad knowledge about ADME processes and relevant in vitro models of drug disposition. Track record in development, characterization and application of translatable in vitro models beyond small molecule drugs
Excellent understanding of design and interpretation of in-vitro studies with oligonucleotide drugs is desired, experience from metabolic disease in vitro models is a strong advantage
Knowledge in omics technologies and bioinformatics
Experience in bioanalytical techniques, e.g. LC-MS
Scientific leadership, evidenced by a publication track record
Excellent interpersonal skills and good communication skills in English, both verbal and in writing
Strong ability to engage and collaborate across boundaries with a problem-solving attitude and focus on delivery.
Experience from industry environment is a plus, but not mandatory.
Expertise in automation equipment and automated processing would be advantageous

This is an exciting opportunity for a talented oligonucleotide ADME scientist to join a strong team at the forefront of DMPK science. You will get the opportunity to innovate and support the oligonucleotide portfolio of a major pharmaceutical company that has science at its heart and a tremendously strong pipeline whilst being based in the wonderful city of Gothenburg, Sweden. Visa mindre

We’re looking for talented scientists to join our innovative academic-style Postdoc. From our centre in Gothenburg, Sweden, you’ll be in a global pharmaceutical environment, contributing to live projects right from the start. You’ll take part in a comprehensive training programme, including a focus on drug discovery and development, given access to our existing Postdoctoral research, and encouraged to pursue your own independent research in cutting edge laboratories. It’s a newly expanding programme spanning a range of therapeutic areas across a wide range of disciplines.
What’s more, you’ll have the support of a leading academic advisor, who’ll provide you with the guidance and knowledge you need to develop your career. This is an exciting area that hasn’t been explored to its full potential, making this an opportunity to make a real difference to the future of medical science.
About the Opportunity:
This position offers high involvement in improving future clinical trials in nonalcoholic steatohepatitis (NASH) patients; being part of a wide network of experts in the fields of NASH, mathematical modelling and clinical development; maintaining a competitive theoretical research output by providing access to a unique selection of clinical longitudinal nonalcoholic fatty liver disease (NAFLD) cohorts and building upon previous in-house developed mathematical models.
This postdoc opportunity involves the application of mathematical methodology, including combined Markov & quantitative systems pharmacology (QSP) modelling and machine learning, to unique clinical longitudinal NAFLD cohorts. The aim is to unveil previously unknown predictive patient-specific factors important for NASH disease progression to inform and optimize clinical development with respect to patient selection, clinical trial duration, as well as human dose prediction.
This is a collaborative project across multiple functions within AstraZeneca R&D, and support will be provided by experts within each function, by renowned academic experts in the field of NAFLD as well as the academic supervisor in this project, Prof. Rohit Loomba (UCSD US), one of the most prominent leaders of NAFLD in the world. This project also offers the opportunity of a secondment with Prof. Loomba at UCSD (University of California in San Diego).
This strong network of experts will help to ensure a high impact publication track record. Thus, the position offers the ability to maintain a competitive theoretical research output. Mentoring of master students and teaching is not required for this position but encouraged and supported.
Our primary objective is to improve the design and evaluation of future clinical NAFLD/NASH trials by developing a framework to predict fibrosis progression using external clinical cohorts, pharmacometric methodology and fit-for-purpose machine learning.
Education and Experience
Essential:
PhD in Applied Mathematics, Statistics, Pharmacometrics or a related field
Programming experience within R/Matlab
Experience with applied statistical modelling

Desirable:
Hands-on experience of working with biological or clinical data
Experience in longitudinal, mixed effects and/or Markov modelling
Scientific excellence as shown by previous work, publication list or references from scientific mentors
Prior understanding of the drug-development process

Required Skills and Capabilities:
Strong computation and programming skills (in R, Matlab or other relevant language)
Proficiency within applied statistical modelling, such as longitudinal, nonlinear mixed effects and/or Markov modelling methods
Excellent written and oral communication skills and ability to work and communicate across disciplines
Curious and passionate about using quantitative methods to advance medicine

This is a 3-year programme. 2 years will be a Fixed Term Contract, with a 1 year extension which will be merit based. The role will be based in Gothenburg, Sweden, with a competitive salary on offer Visa mindre

Do you have a passion for Science? Would you like to apply your expertise to impact 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.


In Pharmaceutical Technology and Development (PT&D), we are the bridge between brilliant science and innovative medicines that 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 early toxicology studies and clinical trials to developing the technology to ensure drugs can be scaled up for commercial manufacture.

We are currently looking for an Analytical Senior Scientist in Large Molecule characterization to strengthen our team and join us in New Modalities and Parenteral Development (NMPD) function.

Within NMPD our vision is to transform product design and development to enable us to deliver New Modality and Parenteral Medicines to Patients. New Modalities is a key area for AstraZeneca, covering synthetic large molecules. New Modalities can include mRNAs, Peptides, Oligonucleotides, Dendrimer Drug Conjugates and Polymer Drug Conjugates. This is an exciting new field and is expected to change and grow in the near and long-term future.

Main Duties & Responsibilities
You will be responsible for delivering analytical knowledge that encompasses understanding of manufacturing processes, control strategy and robustness. You will work cross functionally with multiple internal and external interfaces (Manufacturing, Chemical and Formulation Development, Regulatory CMC, Quality Assurance, Supply Chain and Contract Research Organisations), supporting drug projects from the early clinical phase through to commercial filings.

Your main responsibilities will involve the following:
Develop analytical control strategies for new medicinal products within the New Modalities portfolio, leading to the registration of new medicines.
Lead drug product analytical activities to support project progression during the clinical development phases through to commercialisation
Demonstrate scientific leadership to facilitate strategic development of drug projects and technical development of other scientists;
Plan and execute experimental work in accordance with project timelines
Understand the external regulatory environment for New Modalities and support the development of AstraZeneca’s regulatory strategy
Deliver CMC content or contributions to regulatory filings throughout the clinical development phase and preparation of successful query responses to questions, applying sound knowledge of regulatory guidelines (e.g., ICH, EMEA, FDA) and other territorial requirements.


Essential Requirements
BSc, MSc or equivalent in a relevant discipline with a proven track record in the pharmaceutical environment or a PhD with significant experience, working with large molecules (e.g. mRNA, oligonucleotide or peptide modalities).
A strong understanding of key analytical techniques for the analysis and characterisation of large molecules, especially chromatography and mass spectrometry.
Experience of characterising and developing analytical methods for large molecules.
Scientific leadership skills, the ability to deliver robust scientific contributions to projects and demonstration of utilising risk-based approaches for successful delivery.
Good communication and stakeholder skills, and the ability to discuss complex ideas in a simple, easy to understand manner.


Desirable Requirements
Experience of authoring CMC content for the analytical aspects of drug product regulatory filings throughout the clinical development phase.
An understanding of the principles and management of SHE and cGMP.
Experience of technical supervision, coaching and mentoring or leading small teams of people or scientific projects.
Effective influencing and prioritisation skills to ensure project delivery to deadlines.


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 recognising their potential. Join us on our journey of building a new kind of organisation 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. Visa mindre

Do you have experience in regulatory writing within the pharmaceutical area, enjoy flexible working and leading the authoring of clinical documents for the NDA and MAA? Would you like to apply your expertise to make an impact at a company where we work together across global boundaries to turns ideas into life changing medicines? If so, we welcome you to join us at AstraZeneca!


We are looking for a Associate Director/Senior Medical Communications Scientist to join a great team in Gothenburg, Sweden, who wants to play a part in our everyday work to make a difference for our patients. This is an exciting opportunity to author complex documents and submissions, take on strategic responsibilities and lead global authoring teams.

Our critical, core drug development expertise is at the heart of our three vibrant scientific centres in Gothenburg (Sweden), Cambridge (UK) and Gaithersburg (US). Our strategy and ability to transform our portfolio means we have a late stage pipeline that presents incredible opportunities to push the boundaries of science to deliver life-changing medicines.


What you’ll do:
As a Medical Communications Scientist (MCS), you will provide expert communications leadership to late stage drug projects and drive strategic medical writing, advocating communications excellence in your team. The MCS ensures that NDA/BLA/MAA/JNDA/CN/ROW clinical documents align with project strategies, meet regulatory requirements and adopt best communications practices. The role will afford you flexibility in ways of working.


Accountabilities as MCS:
Lead development of the clinical submission communication strategy for a new product, liaising with senior project staff
Prospectively develop a storyboard for the submission and identify how the proposed prescribing information will be supported
Lead the authoring of clinical documents for the NDA and MAA
- Author the most complex and important documents (eg, Clinical Overviews, Briefing documents for regulatory authorities and Advisory Committees)
- Lead a team of medical writers (internal and external) to deliver
- Ensure alignment of clinical submission documents with the proposed prescribing information
- Represent medical writing on the high-level, cross-functional submission team



Essential in the role:
Solid experience in writing regulatory documents at study-level (eg, Clinical Study Reports), with a good understanding of pharmaceutical drug development. You will be ready to progress authoring more complex documents such as regulatory submissions within a global, strategic role.


As well as:
MSc or PhD within Life Science or equal education
Demonstrated regulatory writing experience gained within the pharmaceutical/medical industry/CRO.
Willingness to undertake domestic and international travel as required by the project.



A desirable requirement is that you have CTD Submission experience.


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 recognising their potential. Join us on our journey of building a new kind of organisation to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work and bringing unexpected teams together! Visa mindre

Do you have experience of working with Regulatory Information and would like to work in a global team environment? Are you interested in a new challenge in the ever-changing environment called RIMs (Regulatory Information Management System)? Then this role is something for you!


At AstraZeneca we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. We are now looking for a Regulatory Information Manager to join our team in Gothenburg, Sweden.


The Regulatory Information Team is a part of Global Regulatory Affairs that works with bringing together technology, processes and resources to enable AstraZeneca’s regulatory strategy. We maintain Regulatory Information in line with legal requirements and company objectives and oversee Regulatory systems, business processes and compliant usage to ensure that the objectives of the regulatory information are met. The RIM team partners with individual system and information owners within Regulatory to ensure the overall strategy for RIM. Another important task is partnering with our IT organization and other Business functions as well as with vendors to influence health authority and industry innovation. There is an extensive collaboration with all business units creating regulatory information across the entire value chain, from development through marketing, maintenance and pharmacovigilance.


Main duties and responsibilities
As a Regulatory Information Manager, you will be an expert in end-to-end tracking and documentation, which includes set-up, follow up and documentation of regulatory submissions and approval information. You will also be an expert in understanding Health Authority legislation interpretation as well as the regulatory requirements regarding licenses and clinical trials aspects of tracking and life-cycle management. To be successful in this role you will have to show a demonstrated ability to work collaboratively in a global team environment and have good project management skills. You need the ability to work independently and to set and manage priorities, resources, performance targets and project initiatives in a global environment. It is important that you can demonstrate an understanding of the characteristics in building successful supplier relationships, monitors Service Level Agreements (SLAs) and manages routine quality, resource and performance issues to resolution.


Essential Requirements
Minimum 1-year hands-on experience with tracking of regulatory information
University degree or equivalent experience in life sciences or technical field
Ability to provide global expertise on requirements for tracking of regulatory submissions and approvals
Ability to assess data, documentation and processes for regulatory impact/compliance with relevant regulations and guidance and clearly communicate requirements to immediate stakeholders
Ability to use project management principles and techniques
Experience from planning of large and complex business activities
Demonstrates a broad working knowledge of process improvement methodologies, tools, techniques and their application
Excellent English written and verbal communication skills



Desirable Requirements


Experience of system administration for validated applications within a regulated environment
Knowledge of AstraZeneca submission, publishing, approval processes, tools and standards
Experience in using publishing and tracking applications
Ability to manage 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
Good problem and conflict resolution skills Visa mindre