Associate Director DMPK Bioanalytical

Work at the cutting-edge, where scientific innovations and an entrepreneurial spirit are the norm.

And in return… we’re looking for individuals with curious minds, who are comfortable taking smart risks and learning from failures.

Bold Disruptors. Push the boundaries of science. Fearlessly break new ground

Work at the cutting-edge, where scientific innovations and an entrepreneurial spirit are the norm.

And in return… we’re looking for individuals with curious minds, who are comfortable taking smart risks and learning from failures.

What we do

We are a global, science-led BioPharmaceutical business and our innovative medicines are used by millions of patients worldwide.

Why we love it

With our ground-breaking pipeline comes a bright future – a secure job, exciting opportunities and varied work. We’re on an exciting journey to pioneer the future of healthcare!

What you’ll do

The Associate Director will act as the Bioanalytical Lead at project teams, defining, 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 appropriately developed and validated bioanalytical methods and their transfer 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 regulatory bioanalytical within GxP compliant facilities for the delivery of biotherapeutic bioanalytical data. They will be experienced in participating in regulatory inspections from Health Authorities, submitting regulatory documents and responding to Health Authority questions. They will have demonstrable experience in multiple technology platforms, such as Gyrolab, MSD, PCR, cell-based assays, fluorescence/luminescence plate readers, AlphaLISA, and LC/MS. Additionally, they will be experienced in the bioanalysis of new and novel drug modalities such as cell and gene therapies, vaccines, modRNA, peptides, antibody-drug conjugates, antisense oligonucleotides 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 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 and may lead a team. They will also interact with key stakeholders and Quality Assurance.

Education/Experience required:

  • PhD preferred with significant relevant experience

Essential for the role:

  • Subject Matter Expert in the development and validation of immunochemical, cell-based and molecular assays to regulatory standards for a variety of biotherapeutic molecules including new modality molecules as well as monoclonal antibody drugs
  • Acted as the bioanalytical lead in diverse project teams, defining, leading and implementing bioanalytical strategy
  • Background in biology, molecular biology and/or cell biology for the development of therapeutic biologics
  • Excellent track record in PK, biomarker and immunogenicity testing in clinical trial settings
  • Demonstrable experience of regulated Bioanalysis within a GxP Facility/Test Site
  • 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 attitude
  • Experienced in GxP inspections by Health Authorities such as MHRA, EMA or FDA
  • 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
  • Ability to handle multiple projects and/or tasks concurrently in a fast-paced environment
  • Experienced in outsourcing methods to external CRO partners and scientific oversight
  • Ability to develop, coach and mentor scientific staff
  • Familiarity with spreadsheets, word processing, and graphical computer programs (e.g. Excel, Word, GraphPad Prism, etc.)
  • Background in Pharmaceutical Clinical Trial Research
  • Proven publication and presentation record
  • Exceptional verbal and written communication skills

Desirable for the role:

  • Experienced in Automation platforms
  • Expertise in the bioanalysis of biotherapeutics on LC/MS platforms
  • Knowledgeable and experienced in the requirements for the Integrated Summary of Immunogenicity and Risk Management Plans
  • Supported late stage clinical programs

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 4th February 2022, and we welcome with your application; CV and cover letter, no later than 20th February 2022

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

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