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Join the Global Clinical Program Supply Chain Team

Hays Life Sciences is now looking to recruit a Global Clinical Supply Chain Planner to join the Global Clinical Program Supply Chain team for a 1-year contract assignment at AstraZeneca in Gothenburg.

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 bridge which 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 required to support new medicines - from supplies for use in clinical trials to developing the technology to ensure drugs can be scaled up for commercial manufacture.

Our global Clinical Program Supply Chain team is growing, and we are now looking for Clinical Supply Planner to join our team. Maybe you are one of them? This is a relatively new role in our organization, and you will have a fantastic opportunity to shape & develop the role to drive maximum value for the organization.

As a Clinical Supply Planner you will translate the programme level demand into a supply plan and execute the plan. This will be accomplished by developing and executing optimized plans inline with the Clinical Supply Chain Strategy. You will work closely with Clinical Supply Chain Programme Leads (CSPL) and Clinical Study Leads to match demand & supply and ultimately deliver lifechanging medicines to patients.

Accountabilities include:

* Translating demand in to supply plans, which meet the inventory strategy set out by the Programme Lead (CSPL)
* Providing forecasts to our supply chain partners for each of the bill of material levels in the supply chain
* Executing the supply plan to ensure kits are available to meet patient demand
* Placing orders with a range of supply chain partners
* Tracking progress & escalating issues
* Ensuring timely release of materials through co-ordination of supply chain team
* Owning inventory; Creating and allocating material to match individual study demand & maintaining accurate stock keeping records

Required Skills & Knowledge

* Degree in supply chain related or drug development discipline or equivalent qualification or experience.
* In depth knowledge of R&D supply chain and drug development processes.
* Knowledge of pharmaceutical production, supply chain principles, good manufacturing practice, Food and Drug Administration requirements (or equivalent) and Customs rules and regulations.
* Proficient IT skills and an aptitude for systems.
* Excellent analytical skills and an interest in using data to drive decisions
* Super user for our key supply planning tools

Additional Requirements

* Demonstrated technical skills and mindset in supply chain management including supply planning & inventory management
* Experience of supply chain management tools
* Good understanding of the principles of risk.
* Good influencing, negotiating and problem-solving skills, including across functional, geographical and cultural boundaries.
* Demonstrated experience of training and coaching colleagues
* Excellent English written and verbal communication skills. Visa mindre

Biobank group

Hays Life Sciences is now looking to recruit 2 Biobank Scientists to join the Biobank Group for 1-year contract assignments at AstraZeneca in Gothenburg.

AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. However, as a company we are more than one of the world's leading pharmaceutical companies, we are proud to have a unique workplace culture that inspires innovation and collaboration. AstraZeneca employees are empowered to express diverse perspectives - and are made to feel valued, energized and rewarded for their ideas and creativity.

The arena
Biobank scientists are responsible for the storage and timely supply of human biological samples (HBS) to AZ research projects. HBS are received from e.g. clinical studies or academic collaborations, stored in local biobanks and distributed to projects. The group primarily supports the Sweden Region but partners with other Biobank groups within the Biosamples department globally to provide efficient support across AZ and our partner organisations.

The Biobank group works collaboratively to provide support within agreed service levels with a strong focus on our customers. We strive hard to understand what fits their needs best and to add value through our services. With an increased focus on the value and use of biobank samples we actively seek ways to improve our process or exploit new technology to build a cutting-edge facility.

The role
We are currently recruiting for a temporary Biobank Scientist in the AZ Gothenburg Biobank group within the global Precision Medicine and Biosamples organization. This position will provide the opportunity to work in a dynamic and enthusiastic environment whilst supplying a critical service to drug discovery projects. The work is highly collaborative with the team having a collective responsibility for the overall delivery.
The role is focused on supporting drug discovery projects within R&D Gothenburg by maintaining a high-quality handling and storage of HBS and support projects with requested samples in a timely manner.

As a Biobank Research Scientist, you will be expected to:

* Work as part of the team rotating between the following typical tasks
* Receive and register incoming HBS
* Process requests for HBS to customers
* Manage customer orders using specialized informatics systems as well as databases
* Responding to customer queries via mail or telephone
* Partner with Biobank groups globally as well as internal and external customers and stakeholders
* Act upon day-to-day issues that occur whilst processing HBS samples to ensure continuous improvement
* Identify initiatives to improve efficiency or quality.

The group has a strong emphasis on continuous improvement which takes the form of individual and group projects within the team, the department and across Biobank groups within AZ.

Minimum experience
You should ideally have a degree in a Bioscience or Chemistry discipline and previous experience of laboratory work handling biological samples. Previous knowledge and experience of biobanking is preferred. Experience of working with various IT solutions, including extensive knowledge of Excel, LIMS systems and database usage, is also a clear advantage.
The biobank team is a highly collaborative group working to tight delivery schedules so the ability to be comfortable working at a fast pace with a goal orientated and team focused attitude is essential. Excellent communication skills with a proactive and service minded approach is key.

Preferred experience/requirements
Experience of automated liquid handling and/or tissue sectioning is advantageous. Good analytical and problem-solving skills involving large and complex datasets

Key Attributes

* Ability to plan, perform and evaluate experiments to investigate improvement possibilities in a process
* Knowledge of the drug discovery process
* Interest in logistics and developing processes through customer interactions and technology awareness
* Drive and enthusiasm to solve the root cause of problems and not only overcome the presenting problem
* Thrive on working in a committed team and gain satisfaction from the overall performance of the group Visa mindre

In Vivo Cardiovascular Biology

Hays Life Sciences is now looking to recruit a Senior Scientist for In Vivo Cardiovascular Biology for a 12-month contract assignment at AstraZeneca in Gothenburg.

Senior Scientist, In Vivo Cardiovascular Biology, is a lab-based role where you will explore novel drug targets and support existing projects with key in vivo and ex vivo data. Collaboration is critical for successful delivery of drug projects and you will work closely with scientists/teams from a wide range of different functions within AstraZeneca as well as with external partners and collaborators. Your in vivo work will include experimental work in small animals to broaden the pharmacodynamic and pharmacokinetic understanding of our new drug candidates as well as cardiovascular disease. You will have the opportunity to explore novel techniques and ideas required for progressing existing portfolio and novel science. Some in vitro work can also be part of the role description.

Responsibilities include:

* Independently design, develop, and run experiments as well as analyse results, interpret data and report in vivo studies and ex vivo assays for projects from pre-target identification to clinical stage
* Communicate data and scientific findings at internal and external meetings and through publications in scientific journals
* Proactively contribute to a vibrant and innovative working environment where improvements and new ideas are adopted and freely shared

Essential for the role

* Master or PhD in biology, pharmacology, cardiovascular biology or similar
* Hands-on experience and expertise in handling mice and rats and performing in vivo experiments accordingly
* Entrepreneurial, collaborative and flexible ways of working
* Strong oral and written communication skills
* Excellent English, both spoken and in writing

Desirable for the role

* Scientific background in any of the following fields: cardiovascular disease, heart failure, cardiac regenerative medicine, cardiac metabolism, genetic cardiomyopathies
* Experience with performing open chest surgeries , such as myocardial infarction and intramyocardial injections
* Knowledge and experience in ultrasound imaging and/or MRI imaging
* Background in drug discovery and development in the pharmaceutical industry Visa mindre

Drug Product Delivery (DPD) within Pharmaceutical Technology & Development

Hays Life Sciences is now looking to recruit 2 Drug Product Delivery Operators to join the Drug Product Delivery Team for a 1-year contract assignment at AstraZeneca in Gothenburg.

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. Join AstraZeneca and apply your expertise in a company that are following the science and turn ideas into life changing medicines. We have an exciting opportunity for talented DPD Operators to be based in Gothenburg, Sweden.

Drug Product Delivery (DPD) within Pharmaceutical Technology & Development is the sole internal AstraZeneca department that packs, labels and distributes investigational medicinal products to clinical trial patients. We support launched, pre-launched and products under development within all our therapeutic areas. We work in a fast-paced environment where flexibility and agility enable us to deliver high value to early phase clinical trials.

The DPD Operator role will be a flexible role within Drug Product Deliveries three operational skill areas, Material Management, Pack Label and Distribution. We work in an environment where flexibility and agility enable us to deliver high value to early phase clinical trials. To complement our existing team, candidates with the following experiences is of interest:

* Distribution experience from a complex supply chain organization
* Knowledge / expertise in working with automated/semi-automated equipment in an operational environment
* Drug Product Knowledge including management of Item/article and lot/batch management to ensure traceability on items/articles in a patient kit including a drug product, packaging material and patient labels from the pharmaceutical industry

Main Duties and Responsibilities
The role holder will contribute to the DPD organization applying their expertise in the complex and regulated GMP environment. The work is focused on being flexible and operational within at least two skills. As a DPD operator you will perform and document all the operational work according to written procedures. Be engaged in the development and improvement of internal processes and manage deviations. Be responsible for writing of GMP and SHE procedures within own skill areas and will be responsible for related training and compliance activities. As required maintain defined facilities or equipment according to GMP standards and be proactive to contribute to projects/activities through applying specialist knowledge within appropriate areas.

Material Management & Distribution responsibilities example
Preparing documentation, receiving and packing of investigational medicinal products to clinical trials. Being the main point of contact when it comes to distribution questions for a number of studies.

Pack & Label responsibilities example
Handling batch documentation, primary pack(tablets or capsules in bottles) and secondary pack(labelling of bottles, devices and vials). Being responsible for equipment (manual and automated) including instructions, training, qualification etc.

Essential requirements and skills

* BSc/MSc in chemistry/pharmacy/engineering or equivalent experience. Preferably 2 years' experience within pharmaceutical development
* Demonstrated ability to work with teams in a culturally diverse, complex and changing environment most internally but to some extent externally
* Curious and innovative mindset with problem solving ability - resolve issues with minimal guidance
* Good written and verbal English communication and understanding

Beneficial requirements and skills

* Understanding of principles, applications and management of SHE and GMP in an R&D environment
* Understanding the disciplines in Drug Product Delivery, Supply Chain and Pharmaceutical development in order to contribute to an effective Supply Chain organization Visa mindre

Small Molecule Preformulation and Biopharmaceutical team

Hays Life Sciences is now looking to recruit a Formulation/ Analytical Scientist to join the Small Molecule Preformulation and Biopharmaceutical team for a 12-month contract assignment at AstraZeneca in Gothenburg.

Do you enjoy working in the lab and have experience within formulation and analytical characterization of active pharmaceutical ingredients? Are you interested in developing liquid formulations for early in vivo studies? Do you enjoy to work collaboratively with and learn from highly motivated and skilled scientists? We are looking for you that are a formulation and analytical chemist with experience in the pre-clinical phase of drug development.

AstraZeneca is now seeking a Formulation/Analytical Scientist to join our Small Molecule Preformulation and Biopharmaceutical team within the Advanced Drug Delivery (ADD) function that is part of Pharmaceutical Sciences at AstraZeneca in Gothenburg, Sweden.

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 the one we are looking for. Pharmaceutical Sciences at AstraZeneca delivers the therapies of the future through scientific leadership in drug delivery, design of synthetic routes, and manufacturing of Active Pharmaceutical Ingredients (API) and drug products. Our portfolio of projects spans traditional small molecules, peptides, oligonucleotides to RNA based therapeutics across AstraZeneca's therapy areas. Advanced Drug Delivery (ADD) resides within Pharmaceutical Sciences with a mission to provide novel products to AstraZeneca's clinical pipeline.

As a Scientist working in the pre-clinical development phase within ADD you will support drug projects from a formulation perspective, from the first in vivo studies to candidate drug nomination. You will focus on various small molecule projects and develop formulations and analytical assessments for PK, PK/PD studies, and toxicology studies. You will work as a member of pharmaceutical project teams, and in close collaboration with other analysts, formulators, solid state, biopharmaceutics experts at AstraZeneca.

Preferably, you should be experienced in formulation chemistry as well as in analytical chemistry and have previously been exposed to an industrial setting. You should possess an enthusiasm for laboratory-based work, be flexible and have a collaborative and problem-solving mind-set. We are looking for a scientist with good communication and planning skills, balanced with the ability to work independently. In addition, you will need a strong sense of responsibility, team work and delivery focus.

Main Duties and Responsibilities

* Support drug development projects with formulations for pre-clinical in vivo investigations.
* Perform essential characterization of the formulations e.g. content, impurity, pH and particle size measurements to support studies like stability, homogeneity etc.
* Generate, evaluate and report data clearly and reliably in accordance with current standard procedures.
* Give formulation/analytical support to scientific initiatives together with other specialists within these areas.
* Working as a member of cross-skilled drug development project teams.

Essential Requirements

* MSc degree in a scientific discipline relevant to formulation/analytical science (e.g., chemistry, pharmaceutical technology, surface & colloid chemistry or equivalent qualifications).
* Basic knowledge of analytical methodologies such as spectrometry, separation science (U/HPLC) and physical particle characterization, i.e. particle size measurements.
* Understanding of principles and applications of Good Laboratory Practices (GMP/GLP).
* Ability to communicate in English both orally and in writing.

Desirable Requirements

* 3+ years of industrial experience of formulation work focused on small molecules in pre-clinical drug development phase.
* Profound knowledge within liquid-based formulation science as well as analytical chemistry.

AstraZeneca is a global, science-driven biopharmaceutical company. We turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. Here, we see the impact of our collective ideas and expertise, and the power of science to deliver them.

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

Early Product Development and Manufacturing (EPDM) team

Hays Life Sciences in now looking to recruit 2 Scientists to join the Early Product Development and Manufacturing (EPDM) team for 6-month contract assignments with a chance of extension at AstraZeneca in Gothenburg.

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!

The arena
Pharmaceutical Sciences (PharmSci) is accountable 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.

Within Early Product Development and Manufacture (EPDM) in Gothenburg, Sweden, the manufacturing teams are accountable for delivery of clinical trial material for a vast project portfolio. We have a wide range of manufacturing assets in three separate facilities, supplying different types of products and dosage forms to studies across the globe.

The role
Within the EPDM manufacturing teams, 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.
* Rapidly develop strong competence within relevant process technologies and build credibility and ability to work independently with a high degree of autonomy.
* 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.
* Monitor, secure and follow up on other regulatory requirements according to GMP through associated IT-systems.
* 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.

In joining the 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.

Experience/requirements
MSc in pharmacy/engineering and/or extensive GMP-manufacturing experience from the pharmaceutical industry is essential for this role. Hands on experience with pharmaceutical manufacturing equipment, automation, complex production lines (e.g. continuous) are merits.

We are looking for a Scientist with excellent collaboration, communication, and planning skills with a strong sense of responsibility, team work and delivery focus.

Strong verbal and documentation skills in English is a requirement. We expect you to have a keen interest to learn and operate both simple and complex manufacturing equipment and develop your expertise in pharmaceutical process technology. Visa mindre

Bioscience In Vivo Department

Hays Life Sciences is now looking to recruit a Senior Scientist Pharmacology to join the Bioscience In Vivo Department for a contract assignment beginning 2022-08-15 until 2022-12-21 with a possibility of an extension at AstraZeneca in Gothenburg.

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?

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

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

We are looking for a team player with strong background in histology and related image analysis techniques, ideally complemented by some experience in pathology and 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. Visa mindre

Join the Cell Bank SE team

Hays Life Sciences is now looking to recruit a Senior Scientist in Cell Banking to join the Cell Bank SE team for a 1-year contract assignment at AstraZeneca in Gothenburg.

We now have an exciting opportunity for you to join our Cell Bank SE team in Gothenburg for 1 year as a Senior Scientist. The Cell Bank, part of Discovery Sciences, is a research unit key to the functioning of a large part of Discovery R&D, through storage and supply of stocks of all mammalian cell lines used within AstraZeneca (AZ). The unit works closely with a range of customers across many AZ sites, through the purchasing of all new cell lines, provision of cell lines in culture, generation of cell banks, cryopreservation, storage, and revival of banks, as well as supply of cells to local requestors, and shipments to other sites. To be successful in the role, we see you as a person that enjoys collaboration and team work, and effective interaction across functions, disciplines, and cultures.

This role will be focused on cell banking but may also include some cell engineering. You will be enabling science by acquiring, culturing and banking a large variety of mammalian cells including immortalised cell lines, primary cells and stem cells. The work will also include registration and tracking of cells in databases.

You will be primarily laboratory-based, however you will at times be required to work flexibly across the team to support other tasks.

Key Tasks

* Utilising expertise in cellular biology; independently culture and characterise all types of cells used in drug discovery projects, while incorporating the views of others
* Innovate in the field of cellular biology with a focus on banking and characterisation of cells
* Design and implement 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 the global cell banking network across AstraZeneca, contributing novel ideas and using judgement and knowledge to influence the cell banking field

Essential skills, knowledge & competencies

* PhD in Cell biology, Biotechnology, Biochemistry or a related discipline or a BSc/MSc degree with significant relevant experience, preferably in the pharmaceutical or biotechnology industry
* Expert in cell culturing and banking of a wide range of adherent and suspension mammalian cells; including cell lines, primary cells, iPSCs and stem cells at plate-, flask- and multi-layer cell stack scale
* Skilled in cellular biology techniques used to develop transient and stable cell lines
* Experience with handling of license agreements, material transfer agreements and ethical consents
* Computer literate: articulate, confident and competent in the use of Microsoft Word and Excel, and knowledge in using reagent databases
* Strong organisational and logistic skills

Desired skills

* Experience in working with human biological samples
* Differentiation and reprogramming of iPSCs
* Experience in isolation of primary cells from tissue and/or immortalisation of cells
* Understanding of molecular biology and design of DNA constructs Visa mindre

Applied Stem Cell Sciences team

Hays Life Sciences is now looking to recruit a Senior Research Scientist - Stem Cell Biology to join the Applied Stem Cell Sciences team for a 1-year contract assignment at AstraZeneca in Gothenburg.

Are you an experienced scientist in the field of pluripotent stem cells (PSC) and neuroscience? Would you like to use your scientific skills to drive the development of stem-cell derived neural models for therapeutic development?

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 Applied Stem Cell Sciences in Discovery Sciences, Biopharmaceuticals R&D, as a bench-based Research Scientist to be a key player in developing stem cell models for neuroscience applications.

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 primary cell culture you will have the opportunity to work on in vitro assay development for neuroscience applications. This includes culture and differentiation of induced pluripotent stem cells (iPSCs), primary neuronal cultures and carrying out gene editing experiments where necessary.

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 Skills and Responsibilities:

* BSc/MSc/PhD degree with significant experience in Neuroscience, Developmental Biology or Cell Biology
* Proven experience with human PSC biology and differentiation to neural cell types
* Experience with primary neuronal cultures
* Experience in developing biochemical and cell-based assays in primary and PSC-derived neurons, introducing agents by viral transduction or transfection.
* Proficiency in cellular and molecular biology techniques, including qPCR, ELISA, Western blotting, Flow cytometry, routine immunofluorescence and IHC staining
* Perform in vitro studies to investigate the effects of CRISPR-based gene editing on gene and protein expression and cellular readouts.
* Effectively collaborate within a matrixed research team to facilitate the success of projects. Maintain complete experimental records.

The following skills are highly desirable:

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

Senior Scientist, In Vivo Cardiovascular Biology

Hays Life Sciences is now looking to recruit a Scientist/ Senior Scientist, In Vivo Cardiovascular Biology for a 1-year contract assignment at AstraZeneca in Gothenburg.

Senior Scientist, In Vivo Cardiovascular Biology, is a lab-based role where you will explore novel drug targets and support existing projects with key in vivo and ex vivo data. Collaboration is critical for successful delivery of drug projects and you will work closely with scientists/teams from a wide range of different functions within AstraZeneca as well as with external partners and collaborators. Your in-vivo work will include experimental work in small animals to broaden the pharmacodynamic and pharmacokinetic understanding of our new drug candidates as well as cardiovascular disease. You will have the opportunity to explore novel techniques and ideas required for progressing existing portfolio and novel science. Some in vitro work can also be part of the role description.

Responsibilities include:

* Independently design, develop, and run experiments as well as analyse results, interpret data and report in vivo studies and ex vivo assays for projects from pre-target identification to clinical stage
* Communicate data and scientific findings at internal and external meetings and through publications in scientific journals
* Proactively contribute to a vibrant and innovative working environment where improvements and new ideas are adopted and freely shared

Essential for the role

* Bachelor Degree, Master or PhD in biology, pharmacology, cardiovascular biology or similar
* Hands-on experience and expertise in handling mice and rats and performing in vivo experiments accordingly
* Entrepreneurial, collaborative and flexible ways of working
* Strong oral and written communication skills
* Excellent English, both spoken and in writing

Desirable for the role

* Scientific background in any of the following fields: cardiovascular disease, heart failure, cardiac regenerative medicine, cardiac metabolism, genetic cardiomyopathies
* Experience with performing open chest surgeries , such as myocardial infarction and intramyocardial injections
* Knowledge and experience in ultrasound imaging and/or MRI imaging
* Background in drug discovery and development in the pharmaceutical industry Visa mindre

Translational Genomics team

Hays Life Sciences is now looking to recruit a Senior Research Scientist, Translational Genomics In Vivo Physiology to join the Translational Genomics team for a contract assignment until 2022-12-31 at AstraZeneca in Gothenburg.

The Discovery Sciences, Translational Genomics department is looking for a senior research scientist to be a part of our In vivo target validation team within the Transgenic Models team. The position is based at the AstraZeneca R&D site in Gothenburg, Sweden and we are seeking a scientific and technical specialist in the animal in vivo physiology field. As a successful candidate you are experimentally focused, with strong troubleshooting skills and adept at putting ideas into practice. By planning and performing animal experiments you will significantly contribute to the practical delivery of projects in compliance with AstraZeneca corporate responsibility policies and relevant safety standards. You will have good social and communication skills, be collaborative and be a strong team player. Candidates should further be able to work independently with a positive, goal oriented and problem-solving attitude. Good organizational skills are required and you should be comfortable in presenting your results. Excellent English is required, both spoken and written.

Specific responsibilities

* Perform hands-on experiments within the in vivo target validation discipline, using metabolic, cardiac and behavioural platforms to support all core disease areas
* Ensure that studies are conducted with high quality, dedication and data delivered according to stipulated time lines and project requirements
* Compile, interpret, present and discuss data with the key project teams

The following skills would be a definite advantage:

* Experience in metabolic phenotyping platforms and analysis of metabolic function in mice, for example indirect calorimetry, DEXA and oral glucose tolerance tests (OGTT)
* Experience in assessing heart function in mice by using for example ECG, ultrasound and blood pressure measurements
* Experience in behavioural phenotyping in mice
* Experience in stereotactic brain injections in mice

Minimum Requirements -Education and Experience

* Ph.D degree or corresponding experience in a relevant scientific discipline with expertise in phenotyping mice or, alternatively, a first degree and significant relevant experience in phenotyping mice Visa mindre

Scientist - Molecular biology, Cell & Regenerative Medicine Safety

Hays Life Sciences is now looking to recruit a CVRM Safety Scientist to work the Molecular biology, Cell & Regenerative Medicine Safety for a 10-month contract assignment at AstraZeneca in Gothenburg.

Job Description
Do you have a background in Cellular biology, wants to work hands-on in the lab and is up for a challenge? Do you want to expand your knowledge of the non-clinical safety assessment of the next generation of cell therapies and regenerative medicines? If yes, AstraZeneca might have the position for you!

We are searching for a highly motivated laboratory-based cell biologist to join our team as a Senior Scientist. In this role you will play an important part in our Cardiovascular, renal and metabolic (CVRM) Safety Group within the broader Clinical Pharmacology and Safety Sciences department. The scientist will be based in Gothenburg, Sweden, where we are significantly investing in the Lab4Life design of our R&D building. This will create the collaborative environment across our disciplines to drive the innovation required for 21st century pharmaceutical research.

We value our differences because we recognize that a team is at its most creative when it is made up of people who think differently from one another, in an environment where different views and perspectives are welcomed and valued. This is how we foster continuous innovation, constant learning and growth for us as individuals and for our patients.

What you will do:
Your role will be to primarily support our growing stem cell therapy portfolio but will also include mechanistic safety investigations across CVRM therapeutics. You need experience in the field of safety assays and/or cell biology - and will be responsible for investigating improved ways to assess the safety of AstraZeneca's cell therapy and CVRM therapeutic portfolio and other novel modalities that are rapidly changing the therapeutic landscape.

One of your key research activities will be the development of new in vitro models to predict and assess the toxicity, immunogenicity and tumorigenicity of cell and regenerative medicines. You will also be involved in and gain wider experience of the general toxicological assessment of CVRM therapeutics. Other responsibilities:

* Identify and solve problems and championing science and technology innovations to develop our strategic capabilities.
* Collaborate with leading academics and actively contribute to scientific discipline networks.
* Driving innovation by contributing to presentations and publications you will develop your own and AstraZeneca's scientific position.

In this role you will work closely with other engaged scientists from every part of Clinical Pharmacology and Safety Sciences. You will support pioneering therapeutics by discovering and applying fundamental biological principles to help answer the critical questions the field faces today.

Essential in the role:

* Degree or equivalent scientific qualification in cellular biology or a related subject
* Previous experience of cell biology, cell therapies and/or safety/toxicology assessment would be useful.
* Demonstrated ability and enjoy working in multi-disciplinary teams with effective communication skills: including presenting and relationship building.
* Ability to comply with Good Laboratory Science standards, Safety, Health and Environment standards and other relevant external regulation.

Why AstraZeneca?
It's our combination of curiosity and courage that drives us, inspired by the possibility of doing things that have never been done before. Empowered to step up, we free ourselves from fear of failure to dig deep into the biology of complex diseases and make bold decisions. Celebrating our successes and failures along the way. Visa mindre

Covid Screen Team

Hays Life Sciences is now looking to recruit 2 Covid-19 Assessment Laboratory Scientist to join the Covid Screen Team for a contract assignment until 2022-06-30 at AstraZeneca in Gothenburg.

This facility will be used for high throughput screening for COVID-19 screening of AstraZeneca Key Workers.

Staff within this laboratory will be expected to work a shift pattern to enable 16 hours a day operation across 5 days a week - Tuesday to Saturday and some weeks Mondays as well.
Hours are 7am-4pm, 8:30am-5:30pm or 12pm-9pm in a shifted pattern.

Please apply only if you are satisfied you can accommodate these shift patterns.

This role covers responsibilities in three main areas: the Sample Handling and the Molecular Biology Laboratories. Applicants flex across both areas as well as Data Analysis. The Lab Scientists are responsible for all process stages from arrival of human assessment specimens (saliva) at the sample handling labs to the transfer of virally inactivated samples to the adjacent molecular biology labs. This work is performed in the Biological Safety Level 2 (BSL2) containment facilities with appropriate PPE. The work in Molecular Biology Laboratories consists of all process stages from fully automated RNA extraction and RT-PCR workflows, data analysis and delivery of PCR based results. This work is performed at Biological Safety Level 1 (BSL1) laboratory with appropriate PPE. Applicants should be comfortable performing this process while using PPE.

Primary responsibilities include: visually inspecting specimens for packaging integrity (correct intact number of barrier layers, no evidence of leakage/spillage); assessment suitability (e.g., rejecting samples not properly labelled, containing foreign matter, incorrect volumes etc.); ensuring they are accounted for on the specimen manifest; following inspection, scanning into LIMS system; and transfer to racks for further processing in suitably contained liquid handling automation. Tube to plate transfer, sample lysis and inactivation will be performed on the automation, and once completed the plates will be transferred to the adjacent molecular biology laboratories. On occasion this process may be run manually requiring experience with manual pipetting. The operation of Beckman I series robotics to perform automated magnetic bead RNA extraction procedures; tracking samples through the LIMS system; RT-PCR reaction setup including manual pipetting as well as automated plate preparation using benchtop automation equipment; setting up molecular assays on qPCR instruments; analysis of results and transference to Data/QC analysts for subsequent downstream analysis and data reporting. Individuals will receive full technical and safety training for this whole process which will be performed to strictly defined COVID-19 laboratory SOPs.

Key Requirements for this role:

* Work in BSL2 lab with previous experience of aseptic technique.
* Work in BSL1 lab with previous experience of automation and molecular biology techniques preferred.
* Work with human biological specimens. HepB Vaccination advised.
* Work with infectious samples, ideally experience with SARS-CoV-2 would be desirable
* Attention to detail to ensure chain of custody of samples, strictly adhering to SOPs
* Work with samples which may contain SARS-Cov-2 would be desirable.
* Experience of liquid handling automation would be desirable
* Working and communicating across a fast-paced cross organisational team.
* Experience with RT-PCR data analysis would be desirable Visa mindre

COVID related research

Hays Life Sciences is now looking to recruit 2 Statisticians for COVID related research for a 1-year contract assignment at AstraZeneca in Gothenburg or remotely in Sweden.

Medical and payer statistics is now looking for statisticians for the COVID observational studies with start as soon as possible.

Join a team of statisticians to work on statistical analysis plans and reporting.

Required Background

* Minimum educational level is a BSc degree in statistics, biostatistics or equivalent
* Accurate
* Likely persistent in checking of SAP and reporting
* Good written and spoken English
* Knowledge of RWE statistics is a plus
* Ability to proactively manage concurrent activities within a study or project
* Excellent communication skills and ability to build strong internal and external relationships

Personal Qualities
Candidates should possess good social skills, be strong team player and be able to work effectively in a global organization where teams are geographically dispersed and should be able to work independently.

The statistician has sufficient experience to be working independently on activities relating to design, delivery, and interpretation in evidence generation for payers and health care professionals. This individual can validate the description and results of more technical analyses.

Typical Accountabilities

* Review/Develop Statistical Analysis Plans
* Review/Develop study reports
* Able to assess the quality of analysis, interpretations, summaries, and results communications of complex studies
* Accountable for the quality of the statistical work
* Provide discipline-specific understanding, insight and constructive challenge Visa mindre

Applied Stem Cell Sciences in Discovery Sciences team

Hays Life Sciences is now looking to recruit a Research Scientist / Senior Research Scientist - NGS and Molecular Biology to join the Applied Stem Cell Sciences in Discovery Sciences team for a 9-month contract assignment at AstraZeneca in Gothenburg.

Are you an experienced scientist in the field of NGS applications and molecular biology? Would you like to use your scientific skills to support development of new therapeutics? 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 Applied Stem Cell Sciences in Discovery Sciences, Biopharmaceuticals R&D, as a bench-based Research Scientist to support NGS applications across multiple projects.

The role
You will be based in Gothenburg Sweden, working alongside our stem cell scientists, disease area specialists and genome editing groups. 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.

Primary Responsibilities

* Develop and troubleshoot protocols using molecular biology techniques including RT-PCR, cDNA generation, qPCR, primer design, and ddPCR.
* Execute sequencing of large number of samples
* Assist with the development of new sequencing and molecular biology approaches from bulk and single cells
* Document and summarize results that are clear and actionable
* Required Skills & Experience
* Recent M. S. or B. S. in Molecular Biology with 2+ years of relevant experience in a research or industry position
* Strong experience with molecular biology techniques: PCR, RT-PCR and NGS library preparation including RNA-seq and DNA-seq
* Use of molecular biology techniques with low sample inputs, such as single cells.
* Demonstrable expertise with NGS sequencing platforms including Illumina sequencing.
* Expertise with liquid handling automation technologies
* Excellent collaboration and interpersonal skills to work well with scientists from divergent backgrounds

Additional Skills & Experience

* Familiarity with tools to analyze NGS data and the ability to perform data management functions in R or Python
* Experience in molecular cloning and plasmid purification
* Experience with mammalian cell culture Visa mindre

Translational Genomics In Vivo Physiology

Hays Life Sciences is now looking to recruit a Senior Research Scientist - Translational Genomics In Vivo Physiology for a 10-month contract assignment at AstraZeneca in Gothenburg.

The Discovery Sciences, Translational Genomics department is looking for a senior research scientist to be a part of our In vivo target validation team within the Transgenic Models team. The position is based at the AstraZeneca R&D site in Gothenburg, Sweden and we are seeking a scientific and technical specialist in the animal in vivo physiology field. As a successful candidate you are experimentally focused, with strong troubleshooting skills and adept at putting ideas into practice. By planning and performing animal experiments you will significantly contribute to the practical delivery of projects in compliance with AstraZeneca corporate responsibility policies and relevant safety standards. You will have good social and communication skills, be collaborative and be a strong team player. Candidates should further be able to work independently with a positive, goal oriented and problem-solving attitude. Good organizational skills are required, and you should be comfortable in presenting your results. Excellent English is required, both spoken and written.

Specific responsibilities

* Perform hands-on experiments within the in vivo target validation discipline, using behavioural and metabolic platforms to support all core disease areas
* Ensure that studies are conducted with high quality, dedication and data delivered according to stipulated time lines and project requirements
* Compile, interpret, present and discuss data with the key project teams
* Help out with ex vivo tissue culture experiments when needed

The following skills would be a definite advantage:

* Experience of behavioural phenotyping in mice
* Experience of stereotactic brain injections in mice
* Experience in metabolic phenotyping platforms and analysis of metabolic function in mice, for example indirect calorimetry, DEXA and oral glucose tolerance tests (OGTT)
* Use of viral vectors and non-viral delivery vehicles for in vivo genetic engineering

Minimum Requirements -Education and Experience
Ph.D. degree or corresponding experience in a relevant scientific discipline with expertise in phenotyping transgenic mice or, alternatively, a first degree and significant relevant experience in phenotyping of transgenic mice. Visa mindre

Applied Stem Cell Sciences in Discovery Sciences team

Hays Life Sciences is now looking for a Senior Research Scientist - Stem Cell Biology to join the n the Applied Stem Cell Sciences in Discovery Sciences team for a 1-year contract assignment at AstraZeneca in Gothenburg.

Are you an experienced scientist in the field of pluripotent stem cells (PSC) and neuroscience? Would you like to use your scientific skills to drive the development of stem-cell derived neural models for therapeutic development?

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 Applied Stem Cell Sciences in Discovery Sciences, Biopharmaceuticals R&D, as a bench-based Research Scientist to be a key player in developing stem cell models for neuroscience applications.

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 primary cell culture you will have the opportunity to work on in vitro assay development for neuroscience applications. This includes culture and differentiation of induced pluripotent stem cells (iPSCs), primary neuronal cultures and carrying out gene editing experiments where necessary.

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 Skills and Responsibilities:

* BSc/MSc/PhD degree with significant experience in Neuroscience, Developmental Biology or Cell Biology
* Proven experience with human PSC biology and differentiation to neural cell types
* Experience with primary neuronal cultures
* Experience in developing biochemical and cell-based assays in primary and PSC-derived neurons, introducing agents by viral transduction or transfection.
* Proficiency in cellular and molecular biology techniques, including qPCR, ELISA, Western blotting, Flow cytometry, routine immunofluorescence and IHC staining
* Perform in vitro studies to investigate the effects of CRISPR-based gene editing on gene and protein expression and cellular readouts.
* Effectively collaborate within a matrixed research team to facilitate the success of projects. Maintain complete experimental records.

The following skills are highly desirable:

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

Clinical Data & Insights (CDI) department

Hays Life Sciences is now looking to recruit a Senior Clinical Programmer to join the Clinical Data & Insights (CDI) department for a 1-year contract assignment at AstraZeneca working remotely or in Gothenburg.

Are you a curious SAS Programmer with experience in Clinical Development? Would you like to apply your skills to impact drug development in a company that follows the science and turns ideas into life changing medicines? Join our team to explore and innovate!

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 in medicine, patients and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and development.

Our Clinical Data & Insights (CDI) department is responsible for the management of data-related aspects of AstraZeneca's clinical trials, excluding analysis and reporting. Part of Development Operations, we work across therapy areas and portfolios, supporting early and late-stage clinical programmers from Phase 1 to Phase 3 with an integrated end-to-end approach for clinical data, analytics, insights and risk management.

This is an opportunity for you - a world class SAS Programmer with extensive JReview experience - to join a global and inclusive team. You can be based in one of our vibrant R&D sites in Gothenburg - Sweden or Cambridge - UK.

What you'll do
As Senior Clinical Programmer in our Early Clinical Programming team, you'll have the opportunity to develop reports and graphs in JReview for easier data review and visualization to support clinical trials. You'll also perform SAS programming to provide complex data review listings and reports.

We will rely on you to:

* Collaborate with colleagues and partners across skillsets and locations to deliver clinical trial data in a relevant and appropriate format
* Oversee programming documentation and ensure consistent maintenance of code, logs and output within a regulated computing environment
* Train colleagues and be the Subject Matter Expert of JReview

Essential for the role
You hold a BSc in a relevant field with substantial experience in SAS Programming and programming in data visualization and reporting tools including JReview. We also believe that you have a solid knowledge of Clinical Data Management.

To be successful in this role, you need to have excellent interpersonal skills and ability to collaborate cross functionally and globally. Furthermore, you are a dedicated and great teammate who manages change with a positive approach to the challenges of change for self, team and the business.

Desirable Criteria
Experience and knowledge of CDISC standards

Why AstraZeneca?
Work with curious minds in an inclusive culture. Thrive in a place where the brightest and most curious minds seamlessly come together in our inclusive environment.
We truly believe that everyone contributes with an outstanding set of competence. Your curiosity and passion for personal development combined with support from colleagues, mentors and leaders, will ensure you maximise your skills, abilities and contribution. Visa mindre

Statistical programmer for remote assignment at AstraZeneca!

Hays is now looking for a statistical programmer for a 1-year on-site or remote consulting assignment at AstraZeneca in Gothenburg. Deadline for application is Oct 30th.

Are you interested in becoming part of the group of statistical programming at AstraZeneca R&D Gothenburg? Late-stage Cardiovascular, renal and Metabolism Biometrics is now looking for Statistical Programmers for on-site contract assignments with start as soon as possible.

Join a team of statisticians and statistical programmers to provide programming expertise to the design, conduct, reporting, interpretation, documentation and regulatory submissions of our clinical development programs. Depending on your experience, you may contribute to more strategic planning, quantitative decision making, act as expert in our contact with external providers and collaborators and be a part of the function's adaptation and development of programming tools, standards and praxis.

Required Background
*Minimum educational level is a BSc degree in a relevant subject such as statistics, biostatistics, mathematics, computer science, life science or engineering.
*Expertise in analysis output programming (ADaM, Tables, Figures etc.)
*Expertise in drug development and clinical data standards (CDISC)
*Good collaboration, communication and influencing skills
*Good written and spoken English

Other relevant qualifications
*Higher academic degree
*Expertise in multiple programming software such as R or Python
*Project management experience

Personal Qualities
Candidates should possess good social skills, be strong team player and be able to work effectively in a global organization where teams often are geographically dispersed. You should be able to work independently, take own initiatives and have a positive, goal oriented and problem-solving attitude. It is essential to have good organizational and communication skills and you should be able to analyze and summarize your results and be comfortable in presenting them. Successful candidates will have the ability to communicate subject matter expertise to other experts, as well as an interest in the application of programming in pharmaceutical development. Visa mindre

Early drug discovery

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

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

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

Essential Requirements

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

Desirable Requirements

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

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

Covid-19 Assessment Team

Hays Specialist Recruitment is now looking to recruit a Laboratory Scientist to join the Covid-19 Assessment Team for a contract assignment ending 2022-06-30 at AstraZeneca in Gothenburg.

This facility will be used for high throughput screening for COVID-19 screening of AstraZeneca Key Workers. Staff within this laboratory will be expected to work a shift pattern to enable 16 hours a day operation across 5 days a week - Tuesday to Saturday and some weeks Mondays as well. Hours are 7am-4pm, 12pm-9pm. Please apply only if you are satisfied you can accommodate these shift patterns.

This role covers responsibilities in two main areas: The Sample Handling Laboratories and the Molecular Biology Laboratories. Applicants can specify a preference to work in either area, or to flex across both.

Sample Handling: Scientists working in the Sample handling Laboratories are responsible for all process stages from arrival of human assessment specimens (currently saliva or nasal swabs) at the sample handling labs to the transfer of virally inactivated samples to the adjacent molecular biology labs. This work is performed to Biological Safety Level 2 (BSL2) in LAF containment facilities with appropriate PPE. Prior experience of working with infectious biological material to BS2 and with PPE is a key requirement for working in the sample handling laboratories.

Primary responsibilities include: visually inspecting specimens for packaging integrity (correct intact number of barrier layers, no evidence of leakage/spillage); assessment suitability (e.g., rejecting samples not properly labelled, containing foreign matter, incorrect volumes etc.); ensuring they are accounted for on the specimen manifest; following inspection, the removal of specimen transport tubes from the kit packaging; scanning into the LIMS system; and transfer to racks for further processing in suitably contained liquid handling automation. Tube to plate transfer, sample lysis and inactivation will be performed on the automation, and once completed the plates will be transferred to the adjacent molecular biology laboratories. On occasion this process may be run manually requiring experience with manual pipetting. Individuals will receive full technical and safety training for this whole process which will be performed to strictly defined COVID-19 specific SOPs.

Key Requirements for this role:

* Work in BSL2 lab with previous experience of aseptic technique preferred.
* Work with human biological specimens. HepB Vaccination advised.
* Work with infectious samples, ideally experience that may contain SARS-Cov-2 would be desirable
* Attention to detail to ensure chain of custody of all samples, strictly adhering to SOPs
* Working and communicating across a fast-paced cross organisational team.
* Experience of liquid handling automation would be desirable

Molecular Biology: Scientists working in the Molecular Biology Laboratories are responsible for all process stages from fully automated RNA extraction and RT-PCR workflows to the delivery of PCR based results to data analysts. This work is performed to Biological Safety Level 1 (BSL1) with appropriate PPE. Applicants should be comfortable performing this process while using PPE.

Primary responsibilities include: the operation of Beckman I series robotics to perform automated magnetic bead RNA extraction procedures; tracking samples through the LIMS system; RT-PCR reaction setup including manual pipetting as well as automated plate preparation using benchtop automation equipment; setting up molecular assays on qPCR instruments; and inspection and exporting of primary and QC results for subsequent downstream analysis by Data/QC analysts. Individuals will receive full technical and safety training for this whole process which will be performed to strictly defined COVID-19 specific SOPs.

Key Requirements for this role:

* Work in BSL1 lab with previous experience of automation and molecular biology techniques preferred.
* Work with human biological specimens. HepB Vaccination advised.
* Work with samples which may contain SARS-Cov-2 would be desirable.
* Attention to detail to ensure chain of custody of all samples, strictly adhering to SOPs
* Working and communicating across a fast-paced cross organisational team.
* Experience with RT-PCR data analysis would be desirable Visa mindre

Metabolism In Vitro Team

Hays Specialist Recruitment is now looking to recruit a Cardiovascular Renal and Metabolism (CVRM) Researcher for the Metabolism In Vitro Team for a 6-month contract assignment at AstraZeneca in Gothenburg.

At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because an opportunity no matter how small the start of something can be big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognising their potential.
The AstraZeneca CVRM Research group in Gothenburg is seeking to recruit a high calibre scientist to enable progression of a growing drug project portfolio. Highly motivated scientists are encouraged to apply for the opportunity to join our team of professionals who are passionate about advancing science, to discover and develop novel therapeutics that will benefit patients.

Role Overview
You will play an active role in implementing and executing scientific research and development within the CVRM Metabolism in vitro team, enabling the prosecution of a rapidly growing portfolio of small molecule and biologics drug projects. This is a "hands-on," laboratory based scientific and technical role in our in vitro metabolism team supporting projects from target validation to lead optimisation phases.

Role specifics
This position will be laboratory based and you will be responsible for several technical and experimental processes to support the CVRM Research group.

Responsibilities

* Responsibility for design, execution and analysis of in vitro and ex vivo assays.
* Predominantly functional and cellular screens supporting Target Validation, Lead Isolation and Lead Optimisation for the CVRM Research Area.
* Communicate results, conclusions and recommendations to colleagues, line manager and multi-disciplinary teams.
* Perform extended and specialized characterization when required for projects.
* Record experiments in lab books and databases.
* Play a leading role in assay development and optimization of disease relevant primary and transfected cell assays.
* You would report to an expert member of staff and would be encouraged to be able to plan your daily work within direction set by your supervisor.

You will:

* Be asked to provide interpretation of assay results
* Work within a line and/or matrix/project team.
* Demonstrates scientific rigor in assessing own data and that of others.

Requirements
Essential

* Be a "hands-on" expert with in vitro models and methodologies.
* Enthusiasm for laboratory work, scientific curiosity
* Experience in running in vitro biochemical and cellular assays to provide potency and activity readouts, including use of primary and recombinant cell lines.
* Significant cell culture experience.
* Experience of working with medium to high density microtitre plate technologies
* Experience in data analysis and interpretation
* Experience of working in accordance with established SOPs and codes of conduct.
* Capability to work seamlessly with cross-functional project teams to provide high quality data in a timely manner.
* Demonstrable ability to work within a line and/or matrix/ cross-functional project team.
* Strong interest in providing materials and data for scientifically challenging work
* Strong organizational, time management and communication skills
* Strong, demonstrable analytical ability
* Good oral and written communications skills

Desirable

* Background in metabolic disease research areas.
* Experience of working with disease relevant primary cell assays associated with one or more of the following disease areas: diabetes, obesity, NASH or dyslipidaemia.
* An understanding of biological sciences, familiarity with the drug discovery process.
* Experience of use of robotics for assays and /or sample handling.
* Experience working in pharmaceutical or biotech environment

Behavioral competencies

* Hard working, organized, balanced and meticulous with an ability to work well under pressure.
* Adaptable and a team player with a conscientious attitude and enthusiasm
* Desire to learn and build on the role

Education
Degree in one of the Life Sciences disciplines and equivalent post-graduate or industry experience. Visa mindre

Biomarker team within Translational Science & Experimental Medicine (TS&EM;) department

Hays Specialist Recruitment is now looking to recruit a Biomarker Scientist to join the Biomarker team for a 1-year contract assignment at AstraZeneca in Gothenburg.

Do you have expertise in Biomarker Discovery and Development in Cardiovascular, Metabolic and Renal Diseases? Would you like to apply your expertise at a company that are following the science and turn ideas into life changing medicines? Then you might be the one we are looking for!

We are now looking for a Senior Scientist, Biomarkers Discovery and Development to join the Biomarker team within Translational Science & Experimental Medicine (TS&EM;) department in the Cardiovascular Renal and Metabolic Diseases (CVRM) therapeutic area at AstraZeneca in Gothenburg, Sweden.

CVRM is one of the three main therapeutic research areas within Innovative Medicines and Early Development, AstraZeneca's small molecule biotech unit that deliver candidate drugs into late-stage clinical development. CVRM TS&EM; has the remit to bridge pre-clinical, early and late drug development by providing early target validation in humans and by driving precision medicine approaches through biomarker discovery and development based on understanding of human diseases and access to human patient samples.
The biomarker team has the accountability from pre-clinical to clinical biomarker delivery which include biomarker discovery for identification of target engagement and proof-of-mechanism biomarkers, generation of target related precision medicine hypothesis, analysis of explorative biomarkers in clinical projects, and for outsourcing biomarkers according to good clinical practice for internal decisions in clinical studies.

As a Senior Scientist in the Biomarker team, you will play a key role from preclinical to clinical biomarker delivery for progressing projects and science. This role will be primarily lab based and contribute to building the biomarker strategy i.e. driving biomarker discovery for identification of target-related biomarkers and precision medicine hypothesis generation. You will be responsible for delivering high quality and robust biomarker data package to support project progression across the CVRM project portfolio. This involves implementation of novel biomarker methods, e.g. ligand binding or mass spectrometry-based approaches using state of the art analytical techniques, biomarker analysis, reporting biomarker data and evaluation to the project teams

Collaboration is critical for successful delivery of drug projects and you will work closely with scientists/teams from a wide range of different functions within AstraZeneca. In this role, you will have the opportunity to try novel techniques and ideas for identification of new biomarkers.

Requirements

* Deep expertise in a range of analytical techniques for biomarker analysis (proteins, peptides, mRNA), specifically immunoassay/ELISA platforms (MSD, Luminex, SIMOA etc.), Taqman analysis and proteomics based on liquid chromatography mass spectrometry
* Experience in development of novel bioanalytical methods for quantification of biomarkers
* Experience in biomarker discovery and development within cardiovascular, renal and metabolism
* Ability to plan and report all work to appropriate standards (Good Laboratory Standard, GLS)
* Maintain awareness of relevant areas of research, drug discover/development technologies and regulatory requirements through reading scientific literature and guidelines
* Perform problem solving studies by identification of issues and where necessary designing experiments to overcome problems.
* Good project management and matrix leadership skills, ability to collaborate well cross functions
* Passion for delivering and promoting excellence in science.
* Excellent English communication skills, both verbal and written Visa mindre

1-year consulting assignment at AstraZeneca in Gothenburg within protein expression

Hays is now recruiting a senior scientist for a consulting assignment at AstraZeneca in Gothenburg. The role is within the Protein Expression Team in Discovery Biology. The assignment is for 12 months and deadline for application is September 15th.

About the assignment
At AstraZeneca we use scientific excellence as the foundation to drive success of our drug discovery pipeline. Such excellence stems from strong collaboration, clear direction and a focus on applying cutting-edge research to support drug discovery.

An opportunity is now available for a highly motivated Scientist/Senior Scientist to join the Protein Expression Team within Discovery Biology, Discovery Sciences, BioPharmaceuticals R&D in Gothenburg, Sweden. Leading from the bench, you will apply proven skills in molecular biology, recombinant protein expression, a passion for investigating scientific questions, combined with strong team working ethics, to drug discovery projects. You will join our team whose remit is to support drug discovery projects globally with delivery of impactful recombinant protein reagents used for disease target identification and validation right through to clinical candidate evaluation.

As part of a team within the Discovery Sciences organisation, you will be working within a vibrant scientific environment to support drug discovery. We push scientific advances in small molecules, oligonucleotides as well as other emerging technologies, always with a view to providing medicines to improve patient care. The Discovery Biology Department of Discovery Sciences is responsible for the generation of novel reagents and assays to support projects in the drug discovery pipeline from target discovery all the way to clinical candidate.

Main duties & responsibilities
This is a lab-based role, generating bespoke protein reagents to support projects in all phases of the discovery process. The role involves application of leading molecular biology techniques to design expression constructs, make DNA constructs for protein expression, producing recombinant proteins that impact projects, as well as troubleshooting. In addition, you will be required to make a significant contribution to the development and application of novel science to advance our capabilities in the production of molecular biology tools used in early drug discovery.

Essential requirements
* Master or Ph. D in Molecular Biology, Biotechnology, Cell Biology, Biochemistry or a related discipline, or 3 years of relevant working experience within Biotechnology
* Substantial expertise in cell culture for recombinant protein expression in a variety of eukaryotic cell types, at scales from 1ml to 20L
* Excellent communication skills and an ability to operate effectively in a multi-disciplinary research environment
* Independent analysis and evaluation of complex data and delivery of data to agreed timelines
* Proven ability in providing technical leadership and guidance to others
* Maintain an awareness of relevant scientific and technical advances to help identify opportunities for capability development

Desirable requirements
* Experience in design of DNA construct for recombinant protein expression is highly desirable
* Experience in use of automation equipment such as liquid handling platforms is desirable
* Experience in expression of recombinant expressed proteins in baculovirus-infected insect cells
* Good understanding of drug discovery and how to contribute with scientific expertise within own area of expertise to drive project progression
* Excellent problem-solving skills, not limited to own area of expertise
* Clear and firm decision-making skills, coupled with tenacity to see decisions through, even in situations of ambiguity Visa mindre

Reg Process & Compliance team, Global Regulatory Excellence

Hays Specialist Recruitment is now looking to recruit an Associate Director - Regulatory Processes for the Regulatory Process and Compliance team for a short term contract assignment until 2021-12-31 at AstraZeneca in Gothenburg or Remotely.

Act as technical writers and project management support to ongoing procedural Working with the Processes Directors, taking responsibility for the management of assigned AstraZeneca projects, processes including implementation, communication, compliance, performance and inspection readiness. Accountable to develop relationships across Regulatory Affairs and other relevant areas of AZ to execute the delivery of the processes strategy, priorities, alongside governance and management of the current procedural documents.

Responsibilities:

* Support authoring and Project Management of procedural document such as Standard Operating Procedures, Work Instructions and Best Practice documentation
* Identify opportunities for and drives the enhancement of existing processes through knowledge of internal and external environment.
* Working with the Process Directors, and Patient Safety and Regulatory experts, develop, establish, monitor, report and assess global KPIs related to safety and regulatory data reporting.
* Utilise safety and regulatory knowledge to maintain and support the global inspection readiness strategy.
* Using deep understanding of regulatory and pharmacovigilance processes and regulations provide process or compliance 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.
* Support activities required to prepare for or in response to for GVP, GCP, GRP and GMP audits/inspections
* Provide process training to relevant functional groups.
* Contribute to communication and change management activities associated with process initiatives.
* Working collaboratively to provide expertise and sharing best practices across all regions.

Education, Qualifications, Skills and Experience:
Essential

* A science/pharmacy/nursing degree, with at least 5 years 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

* 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. Visa mindre

Patient Safety Centre of Excellence team

Hays Specialist Recruitment is now looking to recruit an ECG Scientific Advisor for the Patient Safety Centre of Excellence team for a 1-year 50% FTE contract at AstraZeneca in Gothenburg.

Patient Safety Centre of Excellence´s (PS CoE) vision is to pursue functional excellence for Patient Safety across the business by providing specialised expertise in Safety Science, Pharmacovigilance and Risk Management, while optimising Safety Processes, Systems, Policy, Compliance and Governance.

The Cardiovascular Safety Center of Excellence (CVS CoE) is a function within PS CoE that focuses on solving complex Cardiovascular Safety issues across the therapeutic areas. We strive toward Scientific, Technical and Operational excellence in ECG study design, analysis and interpretation using state-of-the-art, in-house developed tools.

An ECG Scientific Advisor plays an important role in evaluation of digital ECGs in clinical studies. See below for responsibilities and tasks:

* The ECG Scientific Advisor is responsible for timely delivery of accurate ECG analysis results to Study Teams and for operational input to the Clinical Study Protocol regarding the collection and analysis of ECG data.
* Delivers preliminary data analysis to the AZ ECG Centre Cardiologist as basis of Dose escalation safety reports for Safety Review Committee meetings
* Coordinates the review of study documentation related to cardiac safety and ECG in the Study synopsis, Clinical Study Protocol and Clinical Study Report
* Delivers the ECG analysis, data exports and specific reports in allocated studies

Minimum Requirements for the role:

* Registered Nurse or Biomedical Analyst (BMA),
* Minimum of 3 years experience from Cardiac Intensive Care Unit, Arrhythmia unit, Clinical Physiology or Cardiac Electrophysiology lab.
* Competence in ECG analysis and interpretation
* Experience with the Office programs and monitoring systems.
* Experience of cardiac digital systems (Holter telemetry or another system)

Skills and Capabilities:

* Experience of cardiac digital systems (Holter telemetry or another system)
* Strong communication skills in English
* Teamwork and collaboration skills
* Task-oriented
* Service minded and customer focused Visa mindre

Senior Project Manager

Hays Life Science is now looking for a Senior Project Manager - PV for a consulting assignment at AstraZeneca in Gothenburg. The assignment is initially for 1 year with possibility of extension for an additional year. Send your application no later than August 17th.

Day-to-Day Duties

Leads small projects or supports large projects/programmes. Main focus will be support to oversight of outsourced services for patient safety, including those relating to the AstraZeneca Covid-19 vaccine. The individual has a working knowledge of project management methodologies, tools and templates and contributes to the development and maintenance of work products or change programmes. They ensure that business requirements are effectively captured, and are responsible for effective tracking and reporting of project management information and highlighting and supporting resolution of areas of risk in project delivery.

* Provides support to the Patient Safety Director in planning, managing, and monitoring outsourced service delivery
* Effectively manages risk and changes to outsourced service scope
* Develops and manages execution of project plans for projects or programmes, including activities, resources, costs, roles, responsibilities and quality and ensures tracking of the project delivering on time and on budget
* Assists in the initiation, coordination and analysis of resource allocation, financial controls and documentation preparation
* Establishes relationships with business stakeholders to capture business requirements and ensure their understanding and commitment to the outsourced service objectives
* Provides support to the departments by gathering and analysing data in the establishment and/or maintenance of corporate business processes, procedures and policies
* Prepares presentation materials for management reports
* Develops online management reports and key performance parameters
* Evaluates and monitors the performance and efficiency of programs to ensure that program implementation is on target
* Assists with the preparation of a variety of reports covering budget status, forecast reports and other management reports
* Works with project staff to prepare cost application and budgets for new business development
Works on overall project planning through reporting on project schedules and deliverables

Required Skills/ Experience/ Education/ Qualifications
* Minimum 2-5 years working in pharmacovigilance
* Minimum 2-5 years vendor management experience
* Experience of managing small projects/programmes or in a similar role
* Well developed organisational and interpersonal skills
* Experience of working with third party suppliers
* Experience of working application of policies, procedures and guidelines
* Life science experience or background

Desirable Skills/ Experience/ Education/ Qualifications
* Business degree / professional qualification
* Experience of working in a global organisation with complex/geographical context
* Data Science

Required/Desired Technical Proficiencies (i.e. Excel, SAP, etc.)
* Fully competent with Microsoft applications Visa mindre

Experienced protein scientist for consulting assignment at AstraZeneca

Hays Life Science is now looking for an experienced protein scientist for a consulting assignment at AstraZeneca in Gothenburg. The assignment is initially for 1 year. Send your application no later than August 20th.

Are you truly passionate about the magic that happens in the lab? Could you see yourself applying your protein science knowledge in a successful pharmaceutical company? Would you like to join a team of highly skilled scientists where both your professional and personal skills are valued?
We have an exciting opportunity for you to join us working within a dynamic scientific environment to support drug discovery with a focus on membrane protein targets. The Discovery Biology department within Discovery Sciences is responsible for the generation of novel reagents and assays to support projects in all phases of the drug discovery pipeline. We focus on scientific advances in small molecules, oligonucleotides and other new technologies and drug discovery platforms across our different core disease areas.
Our stunning campus in Gothenburg is one of AstraZeneca's three strategic science centres. The site is home to over 2,500 employees, from 50 different nationalities. Gothenburg includes the complete range of functions, and as such offers plenty of development opportunities for a wide variety of professionals. Our science teams in Gothenburg collaborate with academic and industry partners in Sweden and globally. And the site itself is designed with collaboration in mind. From the Coffee Lab to exercise areas, we've built a series of environments where innovation can happen.

Main duties and responsibilities
You will be responsible for producing and characterizing recombinant membrane protein complexes primarily for Cryo-EM structure based drug discovery applications. The purified complexes may further be applied for biophysical assays and affinity screening methods. Mutagenesis and pharmacological profiling will be relevant to optimize bioreagents and in support of molecular mode of action studies. Since this position is predominantly lab based, we expect that you have a true passion for practical duties and high quality data and reagent generation.

We will rely on you to
* Work in a cross functional setting to deliver high-quality membrane protein reagents to projects
* Deliver expertise in protein expression, purification and characterization with a focus on G-protein coupled receptors (GPCRs)
* Contribute with novel ideas and using discernment and knowledge where appropriate to influence the work of the project
* Maintain an awareness of current developments in the literature and contribute to the continuous improvement process
* Achieve personal as well as company scientific visibility through project contributions, presentations, publications and poster & oral conference presentations

Essential requirements
* MSc degree with significant experience from pharmaceutical or biotechnology industry or PhD in Biology, Pharmacology, Biochemistry or other a related discipline
* Expertise in protein science of membrane proteins through a demonstrable knowledge of construct design, molecular biology, protein expression, extraction/solublization, purification, characterization and structure function relationship
* Proven knowledge of a wide range of methods and technologies applied to the expression, purification as well as characterization of membrane proteins, e.g. Eukaryotic expression systems, liquid chromatography, mass spectrometry and biophysical techniques
* Excellent analytical skills, good scientific judgement and communication skills
* Good team working and networking skills with experience of interacting effectively across disciplines and in multi-cultural settings

Desirable requirements
* Experience of GPCRs and cellular pharmacological profiling
* Experience with non-detergent based formulations for purified membrane proteins
* Experience with structure determination methods in particular Cryo-EM Visa mindre

Clinical Supply Program Lead

Hays Life Science is now looking for a Clinical Supply Program Lead for a consulting assignment at AstraZeneca in Gothenburg. The assignment is initially 1 year with the chance of extension. Send your application no later than July 14th.

About the role:
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 bridge which 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 required to support new medicines - from supplies for use in clinical trials to developing the technology to ensure drugs can be scaled up for commercial manufacture.

Are you a strong project leader? Do you have experience in any of the following areas: supply chain, clinic or pharmaceutical development? If so, this could be the next step in your career!
Our global Clinical Program Supply Chain team is growing, and we are now looking for a Clinical Supply Program Lead to join our team in Gothenburg. Maybe you are the one?

As a Clinical Supply Program Lead (CSPL) you will manage and have responsibility for end to end supply to our clinical studies. These supply chains are complex with typically high variability in demand, long lead times, technical complexity, regulatory constraints and high cost of goods. Our customer expectations are high with a focus on 100% availability of medicine to patients, speed to deliver and at a minimal cost. This complexity is likely to increase, and customer demands will remain high.

The CSPL will lead cross-functional Supply Chain Teams and represent Clinical Manufacturing and Supply on PT&D Project Teams (or similar eg. CMC Teams) throughout the life cycle of the project.
The CSPL works in collaboration with customer functions to influence and manage demand and is responsible for all Clinical Manufacturing and Supply project deliverables to the business through leadership of the Supply Chain Team.


Accountabilities include:
* Collaborating with customers (eg. Global Medicines Development, Global Medical Affairs, and other PT&D and Pharm Sci functions) determine, influence and manage demand for drug substance, drug product and patient packs, including requirements for placebo, comparators and rescue/challenge medication.
* Producing a supply strategy documenting the design, setup and how the supply chain will operate for the project.
* Establishing the Supply Chain for development projects and ensure delivery of the end to end supply of materials, moving from development sources to commercial sources of manufacture.
* Understanding GMP (Good Manufacturing Practice) and the impact it has on supply chain activities.
* Monitoring 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.
* Accountable for a significant budget for supply activities and materials for a project.
* Maintaining appropriate information for supply activities in PLANIT on an ongoing basis and in line with RBU.
* Ensuring timely delivery of information to meet internal and external regulatory and legal requirements
* Managing change in demand and supply, resolve issues, escalating when appropriate.


Required Skills & Knowledge
* Degree in supply chain related or drug development discipline or equivalent qualification or experience.
* Extensive experience working in supply chains.
* Significant experience managing and influencing customer demands.
* Significant knowledge of drug development, manufacturing, supply chain and clinical processes including GXP standards.
* Experience of project management. Visa mindre

Clinical Supply Study Lead for 1-year consulting assignment

Hays Life Science is now recruiting a Clinical Supply Study Lead for a 1-year consulting assignment at AstraZeneca in Gothenburg. If you find this role interesting please submit your CV in English asap, deadline is July 8th.

The assignment
Can you envision using your supply chain knowledge to lead clinical supplies for global clinical studies? Would you like to apply your expertise to impact the development of medicines to patients? Then AstraZeneca is the place for you!

We have exciting opportunities for two hardworking Clinical Supply Study Leads (CSSL) to join our team in Gothenburg, Sweden. This is a key role within our Clinical Manufacturing and Supply teams and involves running a portfolio of studies across all phases of a drug development programme ensuring on time delivery to patients.

In Pharmaceutical Technology and Development (PT&D), we are the bridge which turns forward-thinking science into actual medicines that help millions of people around the world. 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.

Role description
As a Clinical Supply Study Lead, you will project manage the delivery of clinical supplies effectively and consistently, and input to the balance of costs and any risks to supply. You will also lead the Study Drug Working Group and contribute to the Supply Chain Team Meetings, enabling continuous cross-functional dialogue with both internal and external partners on study design requirements and associated changes.

We will rely on you to:
* Monitor the budget for your individual study supply activities and materials for the project, including packaging, labelling and distribution costs
* Work within GMP Quality Management Systems, ensuring that you actively handle any deviations, complaints and change controls
* Manage the Interactive Response Technology (IRT) system, to execute demand and supply planning
* Take ownership for inventory management, including any rework and recalls, extensions of shelf life and expiry date management, or stock destruction
* Ensure effective communication with project teams and key partners across a global network
* Support risk management of individual studies with proactive mitigation of risks that potentially impact the quality or delivery of supplies

Essential for the role
We believe that you have a Bachelor's Degree in a scientific or business subject area, alternatively equivalent experience. This is complemented by experience from a supply chain environment or pharmaceutical industry.Collaboration is key in this role, and you have great interpersonal skills. You have a track record of driving successful collaborations across locations and specialist fields.

You also possess:
* A holistic knowledge of end to end supply chain activities
* Proven experience of demand planning and forecasting
* Solid experience in running projects and in?uencing customer demands
* Track record of previous risk identification and management
* Proficient IT skills with an ability to adapt and operate in bespoke multiple systems

We truly believe that everyone contributes with a unique set of competence. Your curiosity and passion for personal development combined with support from colleagues, mentors and leaders, will ensure you maximise your skills, abilities and contribution.

Desirable for the role
* Awareness of GMP (Good Manufacturing Practice) and GCP (Good Clinical Practice)
* Knowledge of clinical development processes relevant to the supply of clinical materials
* Knowledge and understanding of Lean
* Experienced in handling Quality Events (Deviations, Change Controls, Complaints) Visa mindre

Global Regulatory Operations

Hays Specialist Recruitment is now looking to recruit a Dossier Manager to join the Global Regulatory Operation team for a 1 year contract assignment at AstraZeneca in Gothenburg.

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

Your direct responsibilities:

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

Essential Requirements

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

Desirable Requirements

* Experience of working with Regulatory document or submission publishing, understanding the different procedures, formats and market requirements
* Planning for and managing submission publishing activities Visa mindre

Development Quality (DevQ) Team

Hays Specialist Recruitment is now looking to recruit a Quality Assurance Partner to join the Development Quality (DevQ) Team for a 1-year contract assignment at AstraZeneca in Gothenburg.

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. Our Development Quality (DevQ) team ensures the delivery of safe, effective and compliant medicines to patients participating in global clinical studies. We set standards and apply scientific and Quality expertise to our exciting drug pharmaceutical development portfolio and help maintain our reputation and license to operate. We also play an important part in the commercialisation of new medicines.

Development Quality is a Global group, with teams located in Macclesfield, (UK), Gothenburg (Sweden), Durham (North Carolina, US), Gaithersburg (US), Redwood City (US) and Bad Homburg (Germany).

Description:
The assignment is to create and implement a Global archiving process for Development Business (across PharmSci, PT&D and DevQ). The assignment also include driving a process improvement project for GMP training process. The role will also be accountable for the DevQ Business Process of Archiving and GMP training ensuring the use of AZ BPM framework within DevQ and across the development functions, PT&D & Pharm Sci. Ensure all applicable regulations and AZ standard is fulfilled by the process and has a holistic view to ensure alignment across related processes. Coach and advise users. Ensuring continuously learning across all processes. As Business Process Owner be accountable for the processes and leads the definition, design and ongoing improvement of the process to ensure; compliant to relevant requirement, efficient, effective and transparent ways of working.
The role holder operates independently with minimal supervision. They use risk management to evaluate compliance issues and develop solutions. Their 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.
Generally, they are responsible for GMP compliance decisions having a major impact on AZ's business and external reputation related to GXP training and archiving.

Accountabilities as BPO
The Business Process Owner is accountable for the process and leads the definition, design and ongoing improvement of the process to ensure; compliant to relevant requirement, efficient, effective and transparent ways of working.
Provide training materials, expert advice and coaching. Through metrics, identify issues and risks, escalate as required. Monitor internal and external signals and trends. Provide a business continuity plan for the process if required
Have a clear understanding of the relationship between operational requirements of a corporate business strategy and customer satisfaction
Assist the management team in the identification of BPO projects that encourage the completion of strategic business objectives.
Ensure risks of the process are identified and mitigated

General accountabilities
Develop and maintain in-depth knowledge of the quality regulations and guidelines applicable to their area.
Proven ability to continually refresh cGMP interpretation and application through self-study and external involvement with industry groups.
Mentor, support and inspire junior colleagues for enhanced individual and team performance.
Work with the Team Leaders/Quality Directors to develop and implement global objectives.
Build and maintain strong customer relationships with other functions whose activities overlap, influence or affect compliance and lead or participate in GxP audits/initiatives with other AZ quality groups.
Develop solutions to a diverse range of problems that require complex judgements, using highly developed levels of conceptual thought, strategic vision and analysis.
Ensure appropriate Quality input to major business improvement projects and may lead projects across the Development functions.
Support Issue Management Teams on archiving and GMP training specific issues.
Operate confidently as part of a global organisation with an integrated mindset to create an organisation with common processes and ways of working.
Drives, role models, and supports a strong lean culture that promotes standardisation, simplification and continuous improvement

Minimum Requirements - Education and Experience
Functional & business knowledge

* Appropriate scientific degree with extensive experience (5-10 years) and with a reputation of working within a pharmaceutical GMP environment, preferably within a pharmaceutical development organisation
* Proven and strong experience in Business Process Management
* Good knowledge of archiving in GMP business
* Strong engagement, communication and stakeholder management skills, including excellent presentation and influencing skills
* GXP training knowledge
* GMP documentation
* Good knowledge and insight in IT systems
* Problem-solving aptitude, preferable LeanSix Sigma certification

Skills and Capabilities

* Experience in Business Process Management and how to apply Lean methods and Tool
* Experience and preferable skilled at facilitation
* Good team working and networking skills
* Excellent team working and networking skills and encourages team effectiveness
* Demonstrates independent judgement and uses risk management in complex situations Visa mindre

Covid-19 Assessment team

Hays Specialist Recruitment is now looking to recruit a Laboratory Scientist to join the Covid-19 Assessment team for a contract assignment starting as soon as possible until 2021-12-31 at AstraZeneca in Gothenburg.

This facility will be used for high throughput screening for COVID-19 screening of AstraZeneca Key Workers. Staff within this laboratory will be expected to work a shift pattern to enable 16 hours a day operation across 5 days a week - Tuesday to Saturday and some weeks Mondays as well. Hours are 7am-4pm, 12pm-9pm. Please apply only if you are satisfied you can accommodate these shift patterns.

This role covers responsibilities in two main areas: the Sample Handling Laboratories and the Molecular Biology Laboratories. Applicants can specify a preference to work in either area, or to flex across both.

Sample Handling: Scientists working in the Sample handling Laboratories are responsible for all process stages from arrival of human assessment specimens (currently saliva or nasal swabs) at the sample handling labs to the transfer of virally inactivated samples to the adjacent molecular biology labs. This work is performed to Biological Safety Level 2 (BSL2) in LAF containment facilities with appropriate PPE. Prior experience of working with infectious biological material to BS2 and with PPE is a key requirement for working in the sample handling laboratories.

Primary responsibilities include: visually inspecting specimens for packaging integrity (correct intact number of barrier layers, no evidence of leakage/spillage); assessment suitability (e.g., rejecting samples not properly labelled, containing foreign matter, incorrect volumes etc.); ensuring they are accounted for on the specimen manifest; following inspection, the removal of specimen transport tubes from the kit packaging; scanning into the LIMS system; and transfer to racks for further processing in suitably contained liquid handling automation. Tube to plate transfer, sample lysis and inactivation will be performed on the automation, and once completed the plates will be transferred to the adjacent molecular biology laboratories. On occasion this process may be run manually requiring experience with manual pipetting. Individuals will receive full technical and safety training for this whole process which will be performed to strictly defined COVID-19 specific SOPs.

Key Requirements for this role:

* Work in BSL2 lab with previous experience of aseptic technique preferred.
* Work with human biological specimens. HepB Vaccination advised.
* Work with infectious samples, ideally experience that may contain SARS-Cov-2 would be desirable
* Attention to detail to ensure chain of custody of all samples, strictly adhering to SOPs
* Working and communicating across a fast-paced cross organisational team.
* Experience of liquid handling automation would be desirable

Molecular Biology: Scientists working in the Molecular Biology Laboratories are responsible for all process stages from fully automated RNA extraction and RT-PCR workflows to the delivery of PCR based results to data analysts. This work is performed to Biological Safety Level 1 (BSL1) with appropriate PPE. Applicants should be comfortable performing this process while using PPE.
Primary responsibilities include: the operation of Beckman I series robotics to perform automated magnetic bead RNA extraction procedures; tracking samples through the LIMS system; RT-PCR reaction setup including manual pipetting as well as automated plate preparation using benchtop automation equipment; setting up molecular assays on qPCR instruments; and inspection and exporting of primary and QC results for subsequent downstream analysis by Data/QC analysts. Individuals will receive full technical and safety training for this whole process which will be performed to strictly defined COVID-19 specific SOPs.

Key Requirements for this role:

* Work in BSL1 lab with previous experience of automation and molecular biology techniques preferred.
* Work with human biological specimens. HepB Vaccination advised.
* Work with samples which may contain SARS-Cov-2 would be desirable.
* Attention to detail to ensure chain of custody of all samples, strictly adhering to SOPs
* Working and communicating across a fast-paced cross organisational team.
* Experience with RT-PCR data analysis would be desirable Visa mindre

Cell and Molecular Pharmacology (CMP) team

Hays Specialist Recruitment is now looking to recruit a Senior Research Scientist - Molecular and Cell Biology to join the Cell and Molecular Pharmacology (CMP) team for a 1-year contract assignment at AstraZeneca in Gothenburg.

Do you have a background in biochemistry or cell biology, aren't afraid of trying new paths and doing things differently? Do you also feel passionate about the possibilities of science to change lives? Perfect, your next challenge might be this role at AstraZeneca!

A position has arisen for a highly motivated (Senior) Research Scientist - Molecular and Cell Biology to join the Cell and Molecular Pharmacology (CMP) team within the Early Cardiovascular, Renal and Metabolic (CVRM) disease area in Gothenburg, Sweden.

Early CVRM is one of three main therapeutic research areas within AstraZeneca that deliver candidate drugs into late-stage clinical development. The CMP team delivers key data based on histology, imaging, biomarker, FACS and bioassay automation to support projects across the Cardiovascular, Renal and Metabolism disease areas.

The role is lab-based, providing dedicated experimental support to our drug discovery programs. The successful candidate will deliver high-quality molecular biology data to build a detailed understanding of pharmacological response and mode of action for small molecules, PROTACs and ASOs. The work includes independent planning and execution of experiments, troubleshooting and timely reporting/presentation of data according to agreed timelines.

Essential Requirements:

* BSc/MSc degree in Molecular Biology, Biomedical, Pharmacology, Biochemistry or a related discipline with significant practical experience.
* Extensive experience in molecular and cellular biology techniques including protein and gene expression analysis, Western Blot, qPCR and cell culture. Ideally applied to relevant cellular assays and in vivo samples.
* Excellent communication skills and an ability to operate in a multi-disciplinary research environment.
* Independent analysis and evaluation of complex data and delivery of data to agreed timelines.

Desirable Experiences and Abilities:

* Experience within Cardiovascular, Renal and/or Metabolic disease areas.
* Expertise in the design, development and validation of assays for compound profiling.
* Experience in flow cytometry.
* Experience working with PROTACs and/or antisense oligonucleotides (ASOs) in Mode of Action studies and pharmacological profiling.
* Proven ability in providing technical leadership and guidance to others.
* Scientific visibility and leadership through project contributions and scientific publications.

The successful candidate demonstrates a passion for driving scientific questions through experimental work, combined with strong team working ethics. You have good social and communication skills, is collaborative and a great team player. You should also be able to work independently and have a positive, goal oriented and problem-solving attitude. Excellent English is required, both spoken and written, and good organizational skills are of use. Visa mindre

Translational Genomics

Hays Specialist Recruitment is now looking to recruit a Senior Research Scientist to the Translational Genomics team for 1-year contract assignment at AstraZeneca in Gothenburg.

Translational Genomics at AstraZeneca in Gothenburg, Sweden, have an exciting opportunity and is seeking a Senior Research Scientist to be part of the Transgenic Models team. The position is available immediately for a highly skilled and motivated cell and molecular biologist/rodent in vivo physiologist with extensive experience and state-of-the-art knowledge in transgenic science & technology. If this sounds like the challenge for you, apply today!

We are looking for an expert in the area of murine transgenesis and its application in both transgenic animal model generation and in vivo phenotyping. This person will devise, champion and develop scientific areas aligned with project needs and be an authority in the area of molecular biology, in vivo science and precise genome editing - to lead this from a lab-based perspective and to make significant contributions to the practical delivery of AstraZeneca project goals.

You will provide disciplinary scientific leadership and represent the department at internal interdisciplinary meetings in addition to external meetings and to publish novel science in high impact journals. Along with this, you will propose experimental strategies, troubleshoot problems and make significant contributions to the practical delivery of projects in compliance with AstraZeneca corporate responsibility policies and relevant safety standards.

We see that you have good social and communication skills, are collaborative and a strong team player. You should also be able to work independently and have a positive, goal oriented and problem-solving attitude. Excellent English is required, both spoken and written, and good organizational skills are essential.

The following skills are highly desirable:

* Molecular biology expertise and experience of working with mouse embryonic stem cells.
* Working knowledge of the latest precise genome engineering tools both in vitro and in vivo.
* Expertise in the generation and phenotypic characterization of transgenic animal models

The following skills would be an advantage:

* Experience in metabolic phenotyping platforms and analysis of metabolic function in mouse models e.g. performing indirect calorimetry and intraperitoneal glucose tolerance tests (IPGTT) to diagnose metabolic function in genetically-engineered mice.
* Experience of murine behavioural phenotyping
* Experience of preclinical mouse models for therapeutic gene editing delivery and efficacy approaches.

Minimum experience

* You should have a Ph.D. degree or corresponding experience in a relevant scientific discipline with experience in drug discovery or, alternatively, a first degree and significant relevant experience in drug discovery.

Generic component of SRS role descriptor
Accountabilities

* To design genome editing-based strategies and tools required to generate in vivo and in vitro reagents to create disease models
* To perform genetic screens in vitro and in vivo using genome editing tools
* To perform confirmation assays of genetic manipulation and functional validation of engineered animals
* To perform in vivo target validation studies in early projects Visa mindre

Biologics Global Technical Operations (GTO) group

Hays Specialist Recruitment is now looking to recruit a Drug Product Tech Transfer Lead to join the Biologics Global Technical Operations (GTO) group for a 6-month contract assignment working remotely at AstraZeneca in Gothenburg.

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.

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.

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 Visa mindre

Discovery Sciences

Hays Specialist Recruitment is now looking to recruit at Senior Research Scientist - Mechanistic & Structural Biology to join the Discovery Sciences team for a 9-month contract assignment starting 2021-09-01 at AstraZeneca in Gothenburg.

At AstraZeneca we win through science, it's at the heart of our every success. That science is only possible when we work together - we'll always make sure you're clear about how your role is connected to our wider mission to show what science can do.

We are seeking a highly motivated and scientifically curious scientist to join Mechanistic & Structural Biology as a Senior Research Scientist. You will have the opportunity to utilize your scientific capabilities to contribute to the progression of key drug discovery programs in a highly collaborative environment. The position will be located at our vibrant R&D site in Gothenburg, Sweden. You will apply proven cell biology expertise for profiling of the effects and mechanism of action of compound treatment in in vitro cellular assays.

In this position, you will join a department whose remit is to support our BioPharmaceuticals drug discovery projects globally with early DMPK assessment, SAR profiling and detailed mechanism of action data. We offer a highly rewarding scientific environment and strong team working ethics. Mechanistic & Structural Biology (MSB) is a part of Discovery Sciences - a multidisciplinary department which drives early drug discovery across AstraZeneca's global Research and Development portfolio.

Main Duties and Responsibilities:
This is a lab-based role focused on generating in vitro pharmacology data in support of drug discovery projects globally with focus on SAR profiling and detailed mechanism of action data in cellular models across multiple modalities including small molecules, PROTACS and therapeutic oligonucleotides. We offer a highly rewarding scientific environment with ample learning opportunities and an expectation to publish new findings. You will be an experienced lab-based scientist, able to interact across a broad range of therapeutic projects and global initiatives within Discovery Sciences and externally. You will also represent the group on Project Teams and drive scientific and technical innovation in our strategic area, including the identification and development of innovative processes and workflows to deliver high quality and detailed data efficiently.

Essential Requirements:

* Ph.D. in Pharmacology, Biochemistry or a related discipline or a BSc/MSc degree with significant proven experience, preferably in the Pharmaceutical or Biotechnology industry
* Extensive experience in molecular and cellular biology techniques, including qPCR, applied to physiologically relevant cellular assays.
* Excellent communication and collaborative skills and an ability to operate effectively in a multi-disciplinary research environment and team
* Independent analysis and evaluation of complex data and delivery of data to agreed timelines
* First-rate decision-making skills, coupled with tenacity to see decisions through, even in situations of ambiguity
* Scientific visibility and leadership through project contributions and external publications

Desirable Experiences and Abilities:

* Experience with additional technologies for quantifying levels and turn-over of nucleic acids in cells is considered meriting
* Expertise in the design, development and validation of cellular assays for compound profiling
* Experience with cells grown in 3D cultures and organoids
* Proven ability in providing technical leadership and guidance to others
* Track record of identifying and adopting scientific and technical advances
* Excellent problem-solving skills, not limited to own area of expertise
* A proven publication track-record from several labs, such as a postdoctoral experience, in a relevant area Visa mindre

Clinical Supply & Operations in PT&D and Global project team

Hays Specialist Recruitment is now looking to recruit 2 Clinical Supply Program Lead/Associate Clinical Supply Chain Leads for a 12-month contract assignment at AstraZeneca in Gothenburg.

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/Associate Clinical Supply Chain 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 program 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.

What you'll do
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

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 Visa mindre

Human Resources Team

Hays Specialist Recruitment is now looking to recruit 4 Talent Acquisition Partners to join the Human Resources team for a 1-year contract assignment at AstraZeneca in Gothenburg.

Are you an experienced Recruiter ready for an exciting role? Can you envision using your Talent Acquisition expertise to impact the development of life changing medicines? Then this is an opportunity you don't want to miss!

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.

Human Resources at AstraZeneca is a fast-paced, creative and purposeful environment where bold, innovative thinking is encouraged. Within HR, we have built a world class Talent Acquisition function - a team with diverse experience, competence and personalities. Here, we partner with hiring managers and cross-functional experts throughout the whole recruitment process and we are passionate about delivering a truly differentiated candidate experience
Our team is growing, and we are now looking for new colleagues to join. We strongly believe that everyone contributes with a unique set of competence. Your curiosity and passion for personal development combined with support from colleagues, mentors and leaders, will ensure you maximize your skills, abilities and contribution.

What you'll do
First and foremost, you will be responsible for managing multiple recruitment processes with local and global top talents. To do this in a successful way, you will partner with hiring managers, HRBPs, business leaders and colleagues.
A typical day includes working with sourcing, branding, interviewing, candidate discussions including offers and managing the recruitment administration process. In addition to the day-to-day recruitment you may also be working with 3rd party suppliers, supporting projects both locally and globally and mentoring hiring managers.

Essential for the role
You have a degree in a Science or Human Resources related field , complemented with experience of handling multiple parallel full life cycle recruitment processes. Your interpersonal skills are excellent, and you have a team delivery attitude.

We also believe you have:

* Experience utilizing a range of attraction channels
* Ability to work in a fast-paced changing agile environment
* Demonstrated ability to collaborate across skillsets, personality styles and cultures

Desirable for the role

* Experience of recruiting Life Science, Commercial or IT talents
* Experience of working a global company Visa mindre

Patient Safety Team

Hays Specialist Recruitment is now looking to recruit 2 Senior Safety Scientist to join the Patient Safety Team for 1-year contract assignment at AstraZeneca in Gothenburg.

At AstraZeneca, we make a difference every day by delivering life-changing medicines to millions of people globally. Our purpose is ambitious and so is our approach. Creating a more agile and inclusive environment means building a culture where we celebrate innovative thinking.
Our Patient Safety team sits within the Chief Medical Office; an integrated, enterprise-wide organization dedicated to defining the benefit/risk assessment of our medicines across the life-cycle, acquiring and maintaining health authority approvals around the world.

Introduction:
The Senior Pharmacovigilance (PV) Scientist role leads the review of safety data and related documents for potential safety issues in collaboration with the Global Safety Physician (GSP) and other PV Scientists. He/she authors and leads PV input to safety documents and regulatory reports. Senior PV Scientist leads meetings and presents safety data and analyses.

Main Responsibilities:

* Leads and/or conducts proactive pharmacovigilance and risk management planning for more complex products, including preparation of the safety aspects of Global Risk Management Plans and Risk Evaluation and Mitigation Strategies (REMS) in partnership with the GSP and others as appropriate.
* Leads PS activities of cross-functional project teams for developmental compounds and/or marketed products.
* Leads and provides safety expertise to Investigator Brochures, Protocols, Informed Consents and Clinical Study Reports.
* Leads the cross-functional Safety Strategy and Management Team (SSaMT) for large and/or complex projects.
* Presents complex issues to Safety Information Review Committee (SIRC) and takes the lead role in data evaluation and discussion of the results with the SIRC Chair, GSP and other key stakeholders.
* Leads and authors the Reference Safety Information (RSI) for multiple and/or complex development products and collaborates with GSP and Clinical representatives as needed
* Authors/provides strategic input or oversight for multiple and/or complex periodic regulatory documents (PBRERs, PSURs, DSURs) according to the agreed process and timelines.
* Authors/provides strategic leadership to regulatory submissions for new products, formulations or indications (NDA/BLA, MAA), in partnership with the GSP and other functional experts.
* Trains and mentors' junior members of the team, e.g. in approved PV processes, analytic methodologies, etc.

Requirements - Education and Experience

* A life sciences/pharmacy/nursing degree, and demonstrated Patient Safety and/or Clinical/ Drug Development experience
* Fluent in written and verbal English
* Advanced knowledge of PV regulations
* Intermediate understanding of epidemiology preferred Visa mindre

Biosamples team

Hays Recruitment Specialist is now looking to recruit 2 Clinical Sample Project Managers to join the Biosamples team for a 1-year contract assignment at AstraZeneca in Gothenburg.

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 in either Cambridge (Melbourne Science Park), UK, Gothenburg, Sweden, Warsaw, Poland or San Francisco, US.

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.

Requirements:

* 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 Visa mindre

Late-Stage CVRM Biometrics

Hays Specialist Recruitment is now looking to recruit 2 Statistical Programmers to join the Late-Stage CVRM Biometrics for 1-year contract assignments to work remotely for AstraZeneca in Gothenburg.

Are you interested in becoming part of the group of statistical programming at AstraZeneca R&D Gothenburg? Late-stage Cardiovascular, renal and Metabolism Biometrics is now looking for Statistical Programmers for on-site contract assignments with start as soon as possible.

Join a team of statisticians and statistical programmers to provide programming expertise to the design, conduct, reporting, interpretation, documentation and regulatory submissions of our clinical development programs. Depending on your experience, you may contribute to more strategic planning, quantitative decision making, act as expert in our contact with external providers and collaborators and be a part of the function's adaptation and development of programming tools, standards and praxis.

Required Background

* Minimum educational level is a BSc degree in a relevant subject such as statistics, biostatistics, mathematics, computer science, life science or engineering.
* Expertise in analysis output programming (ADaM, Tables, Figures etc.)
* Expertise in drug development and clinical data standards (CDISC)
* Good collaboration, communication and influencing skills
* Good written and spoken English

Other relevant qualifications

* Higher academic degree
* Expertise in multiple programming software such as R or Python
* Project management experience

Personal Qualities
Candidates should possess good social skills, be strong team player and be able to work effectively in a global organization where teams often are geographically dispersed. You should be able to work independently, take own initiatives and have a positive, goal oriented and problem-solving attitude. It is essential to have good organizational and communication skills and you should be able to analyze and summarize your results and be comfortable in presenting them. Successful candidates will have the ability to communicate subject matter expertise to other experts, as well as an interest in the application of programming in pharmaceutical development. Visa mindre

Global Technical Operations (GTO) team

Hays Specialist Recruitment is now looking to recruit a Biologics Operations Submission Manager to work within the Global Technical Operations (GTO) team for a 6-month contract assignment working remote for AstraZeneca in Gothenburg.

Position Summary:
The Biologics Operations Submission Manager (BioOps SM) will work within Global Technical Operations (GTO) and, work with BPD and Biologics Operations scientists, managing the preparation and review process of regulatory documents for the quality (CMC) modules. As a member of the SM team, they will coordinate and consult on regulatory filings and writing processes; identify and promote initiatives to advance the AstraZeneca biologics pipeline and support marketed products.

Main Responsibilities:

* Responsible for BLA/MAA delivery and life cycle management of regulatory submission documents working within Global Technical Operations
* Lead or participate in cross-functional teams as the BioOps SM representative to provide submission related expertise
* Lead the process of critical review of CMC regulatory documents and incorporating multiple internal and external reviews into quality documents
* Manage SM activities associated with multiple projects: delivery of documents to submission ready standards
* Participate or lead template and procedure preparations
* Participate in SM-related workstreams within and across departments
* Assists in providing ANGEL business support and training to Biologics Operations network
* Lead or participate in process improvement initiatives.
* Work with Reg CMC, BPD Submission Management and the GTO Product Champion to ensure seamless transfer of submission management responsibilities for post approval submissions and Wave 2+ markets

Minimum Requirements:

* BS/MSc in a scientific discipline relevant to manufacturing and drug development of biologics products, such as cell culture, purification, analytical biochemistry, formulation, device, etc.
* 6+ years of biopharmaceutical industry experience, including 2 years of writing experience in a regulatory environment.
* Experience preparing CMC regulatory documents and/or manuscripts is desired.
* Background in biologics such as monoclonal antibodies and/or vaccines.
* Must have strong interpersonal skills and an ability to influence.
* Must be able to work on multiple projects at once.
* Must be proficient in Microsoft Office.
* Knowledge and understanding of FDA and EMA regulatory requirements and ICH guidelines.
* Experience in working with Style guides and electronic submission systems.
* Project management experience and a high level of organizational skills Visa mindre

PV Process, Partnership and Contracts Excellence

Hays Specialist Recruitment is now looking to recruit a Manager for Pharmacovigilance Processes for a 1-year contract assignment at AstraZeneca in Gothenburg.

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.

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

Education, Qualifications, Skills and Experience

* 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 Visa mindre

Covid-19 Assessment Team

Hays Specialist Recruitment is now looking to recruit a Laboratory Data Analyst to join the Covid-19 Assessment team for a contract assignment to start as soon as possible until 2021-12-31 at AstraZeneca in Gothenburg.

This facility will be used for high throughput screening for COVID-19 screening of AstraZeneca Key Workers. Staff within this laboratory will be expected to work a shift pattern to enable 16 hours a day operation across 5 days a week - Tuesday to Saturday. Hours for this role is 12pm- 9pm. Please apply only if you are satisfied you can accommodate these working hours.

This role covers responsibilities in two main areas: The Analysis of PCR data generated from human specimens to assess the presence/absence of SARS-Cov-2 virus and generation of the data at the Molecular Biology Laboratories.
Analysis of PCR data: Primary responsibilities include: liaising with Covid-19 Assessment Laboratory Scientists to receive exported PCR data; data QC analysts of PCR data and correct tracking and recording of the analysis in the appropriate LIMS database (utilising a proprietary off the shelf data analysis package).

Key Requirements for this role:

* Experience in RT-PCR data analysis
* Previous experience of data analysis software and use of LIMS and databases desirable
* Attention to detail, strictly adhering to SOPs
* Working and communicating across a fast-paced cross organisational team.

Molecular Biology: Scientists working in the Molecular Biology Laboratories are responsible for all process stages from fully automated RNA extraction and RT-PCR workflows to the delivery of PCR based results to data analysts. This work is performed to Biological Safety Level 1 (BSL1) with appropriate PPE. Applicants should be comfortable performing this process while using PPE.
Primary responsibilities include: the operation of Beckman I series robotics to perform automated magnetic bead RNA extraction procedures; tracking samples through the LIMS system; RT-PCR reaction setup including manual pipetting as well as automated plate preparation using benchtop automation equipment; setting up molecular assays on qPCR instruments; and inspection and exporting of primary and QC results for subsequent downstream analysis by Data/QC analysts. Individuals will receive full technical and safety training for this whole process which will be performed to strictly defined COVID-19 specific SOPs.

Key Requirements for this role:

* Work in BSL1 lab with previous experience of automation and molecular biology techniques preferred.
* Work with human biological specimens. HepB Vaccination advised.
* Work with samples which may contain SARS-Cov-2 would be desirable.
* Attention to detail to ensure chain of custody of all samples, strictly adhering to SOPs
* Working and communicating across a fast-paced cross organisational team.
* Experience with RT-PCR data analysis would be desirable Visa mindre

Hays Specialist Recruitment is now looking to recruit at Sr Principal PV Processes and Partnerships for a 1-year contract assignment at AstraZeneca in Gothenburg.

Working with the Processes and Partnership (P&P) leads and Principals in PV Processes, Partnerships and Contracts group in Patient Safety Centre of Excellence, CMO having ownership of the management of assigned AstraZeneca projects, processes and partnerships including implementation, communication, maintenance, compliance, continuous improvements, performance and inspection readiness. Collaborate with functions in CoE, Patient Safety, R&D Oncology, R&D BioPharmaceuticals, AZ Marketing Companies and AZ Legal providing advice, guidance and interpretation of matters relating to assigned areas to ensure compliance with applicable industry regulations and AstraZeneca Global and Local Policies.

Responsibilities:

* Providing specialist knowledge and support to be recognized as experts and source of reference for PV PP&C, Patient Safety and other stakeholders.
* Identify opportunities for and lead the enhancement of existing standards, processes and techniques through expert knowledge of internal and external environment in order to improve the quality, compliance and efficiency of deliverables for the overall group.
* Accountable for assessing the effectiveness of improvement or CAPA initiatives with identification of subsequent further improvement actions as needed.
* Accountable to demonstrate and contribute to a culture of "ownership" with efficient and effective holistic issue management that results in delivery of business need and includes top tier customer/stakeholder engagement.
* Working with the PV P, P&C leads, Patient Safety and Regulatory experts, develop, establish, monitor, report and assess global KPIs related to safety and regulatory data reporting.
* Utilise safety and regulatory knowledge to maintain and support the global inspection readiness strategy.
* Manages relationships/partnerships/alliances external to the AZ CMO function that are essential to delivering AstraZeneca's pharmacovigilance and regulatory LTO responsibilities
* Project manage projects to agreed targets and provide expert operational and/or strategic regulatory or pharmacovigilance input and guidance in cross functional teams.
* Establish a culture of continuous improvement, high performance, flexibility and quality emphasising a "can do" attitude and innovative approaches.
* Contribute to the overall management and oversight of the Pharmacovigilance Quality System.
* Continuously improve the vision and strategy for nominated pharmacovigilance or regulatory processes.
* Lead improvements of reporting tools and analysis processes and technology.
* Performing the monitoring, analysis and trending of data.
* Identify issues and risks and propose options to mitigate them.
* Monitor, interpret and validate current, new and changing legislation, and manage the impact of changes.
* Ensure that appropriate, up-to-date records are maintained for compliance
* Represent PV PP&C in activities for GVP, GCP, GRP and GMP audits/inspections
* Provide support to the outsourcing partner(s) to facilitate compliance with regulatory and legal requirements and maintaining inspection readiness
* Deliver on project assignments supporting the business, e.g., representation or leadership on global cross-functional task forces.
* Provide process training to relevant stakeholders in CMO, partners and other functional groups.
* May represent AZ on industry bodies
* Serve as the delegate, where appropriate, for the PV P, P &C Leads
* Lead development and implementation of strategic outsourcing activities for assigned areas

Education, Qualifications, Skills and Experience
Essential

* A science/pharmacy/nursing degree, with at least 5 years relevant experience (pharmaceutical, regulatory, safety and partnership)
* Knowledge and understanding of global regulatory and pharmacovigilance requirements and an ability to balance this with industry standards to achieve business goals
* Experience from design, development, implementation, maintenance, continuous improvement and ongoing customer support for business processes within the area of focus for role
* Experience in working cross-functionally
* Experience from authoring standards documents (Standard Operating procedures)
* Experience from development and provision of training through virtual meetings and other media
* Leadership skills, including proven leadership of project teams experience
* Expertise 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
* Able to influence whilst maintaining independent and objective view,
* Strong collaboration skills
* Strong negotiation, conflict management and interpersonal skills

Desirable

* Knowledge of AZ Business and processes
* MSC/PhD in scientific discipline
* Excellent knowledge of new and developing regulatory and pharmacovigilance expectations
* Change management experience
* Excellent knowledge of inspections/inspection activities as it relates to Lead Area

Key capabilities:

* Understanding of governance processes
* Process improvement (eg Lean methodology)
* Collaboration/co-ordination
* Financial awareness
* Ability to influence without authority
* Open to multiple perspectives
* Balanced perspective
* Solution focused
* Experience with inspection activities Visa mindre

Biobank Scientist

Hays Specialist Recruitment is now looking to recruit a Research Scientist to work in the AZ Gothenburg Biobank Group for a 1-year contract assignment at AstraZeneca in Gothenburg.

AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. However, as a company we are more than one of the world's leading pharmaceutical companies, we are proud to have a unique workplace culture that inspires innovation and collaboration. AstraZeneca employees are empowered to express diverse perspectives - and are made to feel valued, energized and rewarded for their ideas and creativity.

The arena
Biobank scientists are responsible for the storage and timely supply of human biological samples (HBS) to AZ research projects. HBS are received from e.g. clinical studies or academic collaborations, stored in local biobanks and distributed to projects. The group primarily supports the Sweden Region but partners with other Biobank groups within the Biosamples department globally to provide efficient support across AZ and our partner organisations.

The Biobank group works collaboratively to provide support within agreed service levels with a strong focus on our customers. We strive hard to understand what fits their needs best and to add value through our services. With an increased focus on the value and use of biobank samples we actively seek ways to improve our process or exploit new technology to build a cutting edge facility.

The role
We are currently recruiting for a temporary Research Scientist in the AZ Gothenburg Biobank group within the global Precision Medicine and Biosamples organization. This position will provide the opportunity to work in a dynamic and enthusiastic environment whilst supplying a critical service to drug discovery projects. The work is highly collaborative with the team having a collective responsibility for the overall delivery.
The role is focused on supporting drug discovery projects within R&D Gothenburg by maintaining a high quality handling and storage of HBS and support projects with requested samples in a timely manner.

As a Biobank Research Scientist you will be expected to:

* Work as part of the team rotating between the following typical tasks
* Receive and register incoming HBS
* Process requests for HBS to customers
* Manage customer orders using specialized informatics systems as well as databases
* Responding to customer queries via mail or telephone
* Partner with Biobank groups globally as well as internal and external customers
* Act upon day-to-day issues that occur whilst processing HBS samples to ensure continuous improvement

The group has a strong emphasis on continuous improvement which takes the form of individual and group projects within the team, the department and across Biobank groups within AZ.

Minimum experience
You should ideally have a Master's degree in a Bioscience or Chemistry discipline and previous experience of laboratory work handling biological samples. Previous knowledge and experience (?1 year) of biobanking in a current setting is a clear advantage. Experience of working with various IT solutions, including extensive knowledge of Excel, LIMS systems and database usage, is also an advantage.
The biobank team is a highly collaborative group working to tight delivery schedules so the ability to be comfortable working at a fast pace with a goal orientated and team focused attitude is essential. Excellent communication skills with a proactive and service minded approach is key.

Preferred experience/requirements
Key Attributes

* Ability to plan, perform and evaluate experiments to investigate improvement possibilities in a process
* Knowledge of the drug discovery process
* Interest in logistics and developing processes through customer interactions and technology awareness
* Drive and enthusiasm to solve the root cause of problems and not only overcome the presenting problem
* Thrive on working in a committed team and gain satisfaction from the overall performance of the group Visa mindre

Remote Work

Hays Specialist Recruitment is now looking to recruit a Drug Substance Tech Transfer Lead to work remotely for a 6 month contract assignment at AstraZeneca.

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.

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.

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 Visa mindre

Remote work

Hays Specialist Recruitment is now looking to recruit a Upstream Process Tech Transfer Lead to work remotely for a 6 month contract assignment at AstraZeneca.

Astra Zeneca has an opening for a USP TT Lead (position based out of Gaithersburg MD in US, or Cambridge, UK but would work remotely from current location). We are seeking a highly motivated and experienced upstream tech transfer and manufacturing support professional. This position will be responsible for transfer of upstream processes from development into clinical/commercial manufacturing at CMOs. The position resides within the Cell Culture and Fermentation Sciences (CCFS) department (within Research and Development). Members of the tech transfer function within this department work closely with the process development scientists (located in the US and UK), Operations, CMOs, and QA to ensure appropriate scale up and transfer of clinical and commercial processes to manufacturing production.

Responsibilities:

* Transfer and support assigned project(s) to CMO(s) as upstream tech transfer representative including fit-to-plant, process risk analysis, timely generation of tech transfer documentation, batch record review/approval, managing technical relationship between sending and receiving organizations, campaign monitoring and support, performance analysis and interpretation, investigation support and deviation write ups, process validation documentation review/approval, campaign summary report authoring, and routine presentations to cross-functional teams and management
* Builds and maintains relationships with partner groups
* Proactively addresses risks/issues and influence partners/CMOs to avoid non-conformances and enable efficient transfers
* Represent function on cross-functional teams
* Participate in design or analysis of lab-scale experiments to support process changes, generate robustness data, and/or resolve manufacturing non-conformances
* Write technical assessments and/or reports and deliver presentations

Required Skills:

* Hands on cell culture experience with stirred tank bioreactors (Stainless or single use)
* Cell culture tech transfer and/or development experience
* Hands on or tech transfer experience to at least 200L scale or above
* Fundamental understanding of upstream unit operations such as mixing, bioreactor, and filtration.
* Working knowledge of the scale-up/scale-down principles of cell culture or fermentation processes
* Knowledge of GMP manufacturing principles and documentation
* Skilled in root cause analysis and problem-solving
* Demonstrated critical thinking skills
* Demonstrated technical writing
* Excellent written and verbal communication skills
* Sound decision making with limited data and guidance
* Demonstrated ability to outline issues, assess and present risks/benefits, and ability to make recommendations using sound scientific reasoning
* Skilled in effectively explaining complex scientific or engineering concepts to a broad and diverse cross-functional audience.
* Experience with being an effective and influential contributor and leader to projects governed by matrix teams
* Ability to work in a fast paced environment
* Demonstrated initiative and drive for results
* Demonstrated ability to stand in the face of strong/higher level opposition
* ust be able to work independently
* Experience with data and statistical analysis
* Proven experience in preparing detailed and thorough technical protocols and reports
* Knowledge of the drug development process, global regulations, process validation and ICH guidelines

Desirable Skills:

* Experience in a cGMP-regulated environment and/or large-scale bioprocessing laboratory
* Viral based production experience * Prior experience leading projects outside of area of technical expertise
* Skilled in conducting complex transfer/process development/technology development projects Supervision This position will not have any direct supervisory responsibilities.

Experience

* A Bachelors, Masters or PhD Degree in an engineering or scientific discipline with a focus in a process engineering field (e.g., chemical or biochemical engineering) is strongly preferred.
* The candidate must have relevant industry related experience (BS 8+, MS 6+, PhD 6+ years).
* Position requires periodic weekend work and/or periodic late night work.
* Position may require supporting sites in different time zones.
* Position may require some travel to CMO or other sites (domestic and international). Visa mindre

Precise Genome Editing Team

Hays Specialist Recruitment is now looking to recruit a Research Scientist/Senior Research Scientist - Therapeutic Genome Editing-Gene Therapy to join the Precise Genome Editing Team for 1 year contract assignment at AstraZeneca in Gothenburg.

At AstraZeneca we use scientific excellence as our foundation for driving success in our drug discovery pipeline. We underpin this with strong collaboration, clear direction and a focus on applying cutting-edge research to support drug discovery.
An exciting opportunity is now available to join the Precise Genome Editing team within Discovery Sciences, which has responsibility for the generation of novel genome editing technologies to support projects in all phases of the drug discovery pipeline. We have a focus on target identification, target validation, disease model generation and the therapeutic use of stem cells. We are seeking a scientist to join our team in Gothenburg Sweden, where the role will focus on developing gene editing strategies for potential therapeutic use,.

The role
Leveraging your strong knowledge and experience in genome editing you will have the opportunity apply your knowledge to gene therapy projects. This includes design of genome editing strategies, implement them using techniques including CRISPR/Cas9 and validate the results. The role is focused on conducting laboratory-based activities, applying your knowledge and skills to drive project delivery and scientific innovation, participating actively in problem solving and working globally with AstraZeneca colleagues and collaborators.

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

Tasks

* To design and develop genome editing-based strategies and tools required to generate in vitro and in vivo models
* To implement delivery tools to improve the efficiency of genome editing
* To perform confirmation of genetic manipulation and functional validation of engineered models
* To develop novel engineering tools based on CRISPR/Cas9, base/prime editors

Essential skills for the job:

* Strong knowledge and hands on experience with genome editing tools (including base or prime editors)
* Expertise with CRISPR based manipulation of cell lines and/or stem cells
* Expertise with NGS analysis of genome editing outcomes (Amplicon Seq, Guide-Seq, CIRCLE-Seq, Discover-Seq)

The following skills are highly desirable but not essential

* Basic programming skills with the ability to use and develop in silico genetic analysis tool

Minimum experience
You should hold a Ph.D. in Molecular Biology, Cellular Biology or a related degree or have significant relevant experience working in a precise genome editing/molecular biology environment. Visa mindre