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Regulated Large Molecular Bioanalytical Scientist

Location Cambridge, England, United Kingdom Job ID R-073509 Date posted 02/06/2020

Regulated Large Molecular Bioanalytical Scientist

Cambridge

Salary Competitive

Do you feel passionate about the possibilities of science to change lives? Do you have experience with Bioanalysis and assay validation in a regulated environment? 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 Bioanalysis Scientist 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 Bioanalysis and Biomarkers department, you will be responsible for the validation, development and subsequent application of bioanalytical immunoassays for the determination of pharmacokinetics, toxicokinetics, pharmacodynamics and immunogenicity.

Within this fast paced and dynamic environment, you will be applying Bioanalytical Method Validation regulatory requirements as well as conducting work in compliance with GLP or GCP for labs as applicable. As a recognised bioanalytical 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, we support a variety of therapeutic disease areas working with multiple project teams 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 bioanalytical data and 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 bioanalytical immunoassay-based assays according to regulatory requirements, specifically PK, PD Target Engagement assays, Biomarker assays and Immunogenicity assays.

In this primarily lab-based role, you will act as an analyst with the potential to act as a Principal Investigator for Multi-site GLP studies or as an Analytical Project Manager for Clinical Bioanalysis. 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 may be responsible for overseeing outsourced bioanalytical activities at our partner CROs.

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 bioanalysis 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 3 years relevant experience in bioanalysis.

Applications Open 6th February 2020

Applications Close 7th March 20120



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

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Great culture, great work assignments, supportive management. Rotation opportunity within the company. They value inclusion and diversity.