Associate Principal Scientist – Bioanalytical GxP

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Why we love it

This is the place to make an impact. Here we ensure everyone can reach their full potential, perform at their best and make a valued contribution to the enterprise.

What you’ll do

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.

The Associate Principal 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
  • May manage a team

Education/Experience required:

  • Bachelor’s degree or higher with significant experience

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
  • Acted as Study Director and/or Principal Investigator in a GxP capacity
  • Experience with IND and/or BLA submissions or regulatory questions
  • Experience in line management, mentoring and coaching
  • Proven experience with developing and validating assay on platforms such as MSD, ELISA, ELLA, AlphaLISA and Gyrolab
  • Laboratory experience with GLP regulations, GxP documentation and regulatory guidance
  • Significant experience and track record in immunogenicity assessment in clinical trial settings
  • Experienced in PK and biomarker 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
  • Supported late stage clinical programs

Salary: Competitive

Location: Cambridge, UK

So, what’s next?

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

Advertising opens on 1st June 2021 and we welcome with your application; CV and cover letter, no later than 14th June 2021

For more information please contact: alexander.doyle@astrazeneca.com

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