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Location:
Cambridge, England, United Kingdom
Job reference: R-048477
Posted date: May. 07, 2019
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Do you feel passionate about the possibilities of science to change lives? Do you have experience with Bio-analytics and assay validation? Then this maybe the role for you.

At AstraZeneca, we’re not afraid to do things differently. We’re resetting expectations of what a bio-pharmaceutical company can be. This means we are opening up new ways to work, ground-breaking methods and bringing outstanding teams together.

As a Regulated Large Molecule Bio-analysis Specialist based in Cambridge, UK, you will play a pivotal role to make a direct and positive impact on changing patients’ lives. If you’re inspired by the possibilities of science to make a difference and ready to discover what you can do – join us!

Role specifics

Within the Clinical Immunology and Bio-analysis department, you will be responsible for the validation, development and subsequent app bio-analytical immunoassays for the determination of pharmacokinetics, toxicokinetics, pharmacodynamics and immunogenicity.

Within this fast paced and dynamic environment, you will be applying Bio-analytical Method Validation regulatory mentorship as well as conducting work in compliance with GLP or GCP for labs as applicable. As a recognised bio-analytical professional, this diverse role provides the opportunity to work at multiple stages of the pipeline from lead selection, preclinical stages and all stages of clinical development. Additionally, the projects support a variety of therapeutic disease areas working with a number of different project teams as the departmental project representative and interacting with key partners. Our activities have a direct impact on patient safety, regulatory submissions and product filing applications.

Main Duties and Responsibilities

In this role you will deliver bio-analytical strategy for Pharmacokinetic (PK), Toxicokinetic (TK), Pharmacodynamic (PD), Biomarker and Immunogenicity to support projects through all stages of drug development and post-marketing activities, working closely with Modelling and Simulation departmental colleagues, QA, Biology, Toxicology, Data Management, Stats and Programming and Clinical teams. You will be responsible for the planning, co-ordinating and undertaking of development, validation and use of bio-analytical immunoassay-based assays according to regulatory requirements, specifically PK, PD Target Engagement assays, Biomarker assays and especially Immunogenicity assays.

Acting as a Principal Investigator for Multi-site GLP studies or as an Analytical Project Manager for Clinical Bio-analysis you will deliver results for database locks to agreed time lines to allow effective decision making and support submissions. This includes authoring of critical regulatory documents for submission to Health Authorities such as INDs, CTAs, IBs, BLAs etc. and responding to Health Authority questions.

You will have an expert knowledge of Bioanalytical Method Validation and Immunogenicity regulatory requirements and participate at inspections conducted by the MHRA for GLP and GCP for labs compliance of our certified facility. In addition to in-house lab activities you will also be responsible for overseeing outsourced bio-analytical activities at our partner CROs.

You will coach and support junior scientists by advising and developing them as well as assisting with the interpretation of complex data. There will be opportunity to present project related and other relevant data at internal and external meetings and prepare scientific manuscripts.

Preferred Background

Experience in large molecule regulated bio-analysis within industry or a CRO environment and familiarity with GLP regulatory requirements and method validation guidelines.

Minimum requirement of B.Sc. in a scientific discipline with at least 5 years relevant experience in bioanalysis.

Competitive remuneration and company benefits apply

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applications for employment without discrimination on grounds of disability, gender or gender 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

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Large Molecule Bioanalytical Specialist
MedImmune

AstraZeneca in the UK

Our 6,700-strong UK workforce is based across seven sites in the UK, including our new research facilities and global corporate headquarters in Cambridge. The Cambridge Biomedical Campus (CBC) is globally renowned as a leading centre of research, education and patient care. For AstraZeneca, the campus is the perfect environment in which to foster a vibrant culture of open innovation and collaboration.

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