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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.
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 Senior Scientist – Pharmacology 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 such as antibodies, peptides, oligonucleotides, vaccines etc. in a variety of matrices
- Conduct and delivery sample analysis campaigns in support of preclinical and clinical studies to agreed timelines and data transfer specifications
- Act in the GLP roles of Study Director and/or Principal Investigator as required
- Preparation, review and QC of plans, reports and datasets
- Supervise the transfer and validation of developed PK/ADA assays to CROs working closely with the outsourcing team to ensure high quality and timely delivery for method set up and sample analysis
- Work closely with clinical and bioanalytical teams contributing to immunogenicity assessment and bioanalytical strategies
- Stay current on the bioanalytical techniques and regulations
- Implement new techniques as well as strategies and practices that are in line with industry practices and regulatory requirements
- Active contribution to the bioanalytical field through initiatives, consortium activities, presentations, and publications
- 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
- Participate in internal and regulatory inspections
- Preparation of regulatory documentation such as INDs, CTAs and regulatory responses
- Bachelor’s degree or higher with 5 or more years’ 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 including new modality molecules as well as monoclonal antibody drugs
- Demonstrable experience with PK, PD, and ADA assays
- Experienced with assay platforms such as MSD, ELISA, ELLA, AlphaLISA and Gyrolab
- Laboratory experience with GLP regulations, GxP documentation and regulatory guidance
- Excellent 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.)
- Prior demonstrated industry impact with a background in Pharmaceutical and Clinical Trial Research
- Background in biology, molecular biology and/or cell biology for the development of therapeutic biologics
Desirable for the role:
- Familiarity with Automation platforms
- Experienced in the bioanalysis of biotherapeutics on LC/MS platforms
- Experience with PCR method development and validation
- Demonstrable experience of overseeing and interpreting analyses in multiple platforms from multiple lab-based groups in addition to own immediate organisation
- Correlation and interpretation of PK, PD and immunogenicity data
- Experience with IND and/or BLA submissions
- Supported late stage clinical programs
So, what’s next?
Are you already imagining yourself joining us? Good, because we can’t wait to hear from you!
Advertising opens on 4th June 2021 and we welcome with your application; CV and cover letter, no later than 19th June 2021.
For more information please contact: firstname.lastname@example.org
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