What You’ll do
As the Team Leader of the UK GxP Lab testing lab 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. The ideal candidate will have a strong track record in GxP compliance for regulated bioanalysis, leading teams and driving bioanalytical innovation. They will have an immediate and lasting impact to our pipeline supporting all Therapeutic Areas and implementing PK, ADA and PD strategy, validation, and sample testing.
What you’ll do
The Director UK GxP Team Leader will be responsible for the day to day operation of the UK GLP and GCP for labs certified facility and act as Test Facility and Test Site Management, and be a member of the site GxP Management Team. His/her responsibilities will include the on-going GxP compliance and ensuring the scientific and regulatory quality of method development, assay validation and sample testing for PK, PD and immunogenicity assays to ensure timely data delivery to support nonclinical and clinical studies of non-small molecule drugs. The Director will act as the Bioanalytical Lead at project teams, driving and implementing bioanalytical strategy and provide internal support for the preparation of regulatory documents for the molecules and studies which they, or their team, oversees. They will ensure successful transfer of developed and validated methods to CROs working closely with the Outsourcing Team. As a Subject Matter Expert, they will enhance the iBA reputation for scientific excellence by presenting at internal and external meetings and publishing manuscripts.
The successful candidate will have a proven track record in leading and mentoring regulatory bioanalytical teams within GxP compliant facilities for the delivery of biotherapeutic bioanalytical data. They will be experienced in participating in regulatory inspections from Health Authorities such as the MHRA, and may have previously acted as Test Facility/Test Site Management. He/She will have demonstrable experience in multiple technology platforms, such as ELISA, MSD, fluorescence/luminescence plate readers, AlphaLISA, Gyrolab and PCR. Additionally, they will be experienced in the bioanalysis of new and novel drug modalities as well as established modalities such as antibody biotherapeutics.
This position will report to the Head of Bioanalysis Outsourcing and UK GxP Lab. The successful candidate will lead a team and work closely with all laboratory groups within Integrated Bioanalysis to ensure proper oversight, bioanalytical strategy, regulatory compliance, platform strategy, and delivery of our biologics pipeline. They will also interact with key partners and Quality Assurance.
- PhD preferred with extensive experience.
Essential for the role:
- Demonstrable management/leadership experience of a GxP bioanalytical team in the biopharmaceutical sector
- Ability to develop, coach and mentor scientific staff
- Proven experience as a Study Director and/or Principal Investigator for regulated studies and phases
- Deep understanding of GLP regulations, GxP documentation and regulatory guidance coupled with a quality, systems and process improvement approach
- Experienced in GxP inspections by Health Authorities such as MHRA, EMA or FDA
- Subject Matter Specialist 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
- Excellent track record in PK, biomarker and immunogenicity testing in clinical trial settings
- Interpretation of integrated and complicated datasets such as PK, PD and immunogenicity data
- Contributed to regulatory submission documentation such as INDs, CTAs, IBs and/or NDAs/BLAs and experience in regulatory authority responses
- Background in biology, molecular biology and/or cell biology for the development of therapeutic biologics
- Exceptional verbal and written communication skills
- Ability to handle multiple projects and/or tasks concurrently in a fast-paced environment
- Familiarity with spreadsheets, word processing, and graphical computer programs (e.g. Excel, Word, GraphPad Prism, etc.)
- Background in Pharmaceutical and Clinical Trial Research
- Proven publication and presentation record
Desirable for the role:
- Acted as Test Facility and Test Site Management within a GxP compliant Facility
- Experienced in Automation platforms
- Expertise in the bioanalysis of biotherapeutics on LC/MS platforms
- Proven experience of external vendor and/or sponsor oversight
- Knowledgeable and experienced in the requirements for the Integrated Summary of Immunogenicity and Risk Management Plans
- 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 25th August 2021 and we welcome your application; CV and cover letter, no later than 25th September 2021
For more information please contact: email@example.com
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