Senior Scientist – Bioanalytical GxP

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It drives us to work together as one global team to achieve our goals. A supportive place where all are encouraged and achievement is recognised. Strengthening our knowledge through constructive feedback and coaching, as well as collaborating with the best.

Competent in own research area within DMPK. Initiate and perform research experiments and implementing strategies. Will be able to work mostly without direct supervision and may be able to advise/train less experienced scientists.

The Team

As a member of the Integrated Bioanalysis (iBA) team within the Clinical Pharmacology and Quantitative Pharmacology Department, you will be responsible for GxP bioanalysis in support of the AstraZeneca pipeline across all Therapeutic Areas working from our Cambridge UK location. You will have an immediate and lasting impact to our pipeline supporting all Therapeutic Areas and implementing PK, ADA and PD strategy, validation, and testing.

Clinical Pharmacology and Quantitative Pharmacology provides broad discovery, preclinical, and clinical support across all therapeutic areas enabling pipeline delivery, decision making, and advancement.

What you’ll do

The Scientist/Senior Scientist – DMPK is a member of the Integrated Bioanalysis team delivering regulated bioanalysis within a GLP and GCP for labs compliant facility within the MHRA monitoring programme. In this lab-based role the responsibilities will include:

· Development and validation of immunoassays/cell-based assays, molecular biology assays and target engagement assays for PK, PD, ADA and NAb on a variety of assay platforms for different biotherapeutic modalities in a variety of biological matrices

· Conduct and delivery sample analysis campaigns in support of preclinical and clinical studies to agreed timelines and data transfer specifications

· Preparation, review and QC of plans, reports and datasets

· Work closely with clinical and bioanalytical teams contributing to immunogenicity assessment and bioanalytical strategies

· Stay current on the bioanalytical techniques and regulations

· Ensure that work is conducted in a safe and compliant manner; maintain lab documentation and practice in accordance with established SOPs, GLP and GCP regulations

Education/Experience required:

· Bachelor’s degree or higher with experience in regulated bioanalysis in the pharmaceutical industry or at a CRO

Essential for the role:

· Strong background in the development and validation of immunochemical and cell-based assays to regulatory standards for a variety of biotherapeutic molecules such as monoclonal antibodies, bispecifics and fusion proteins

· Demonstrable experience with PK, PD, and ADA assays

· Experienced with assay platforms such as MSD, ELISA, ELLA, AlphaLISA and Gyrolab

· Track record in PK, biomarker and immunogenicity testing in clinical trial settings

· Detail oriented, exceptional documentation practices, technical writing and verbal communication skills

· Ability to handle multiple projects and/or tasks in a fast-paced environment

· Familiarity with spreadsheets, word processing, and graphical computer programs (e.g. Excel, Word, GraphPad Prism, etc.)

· Background in biology, molecular biology and/or cell biology for the development of therapeutic biologics

Desirable for the role:

· Laboratory experience with GLP regulations, GxP documentation and regulatory guidance

· Prior demonstrated industry impact with a background in Pharmaceutical and Clinical Trial Research

· Familiarity with Automation platforms

Salary: Competitive

So, what’s next?

Are you already imagining yourself joining us? Good, because we can’t wait to hear from you!

Advertising opens on 5th October 2021 and we welcome with your application; CV and cover letter, no later than 20th Octobe 2021.

For more information please contact:

Additional information

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