Senior Director, Analytical Development

vor 4 Wochen


Visp, Schweiz Kodiak Sciences Vollzeit

Job Summary

We are seeking a highly skilled Senior Director, Analytical Development to oversee the development, transfer, and validation of HPLC test methods for the release testing of monoclonal antibodies, fusion proteins, and antibody-biopolymer conjugates in preclinical to late-stage development.

The ideal candidate will have a strong scientific approach, analytical expertise, and QC experience, with a track record of establishing mutual respect, trust, and close collaborations with internal and external organizations.

Key Responsibilities

  • Oversee and manage the development, transfer, and validation of HPLC test methods taking place internally and/or externally
  • Support regulatory interactions and contribute to the content of regulatory documents: IND, IMPD, briefing packages, BLA as needed
  • Establish effective working relationships within Biologics CMC team and with other Kodiak functions

Requirements

  • Master or Ph.D. in a relevant area: Biochemistry, Biotechnology, or Biological Sciences with 5-10 years of industrial Analytical Development and/or Quality Control experience
  • Strong and thorough appreciation and experience in HPLC techniques
  • Experience in management of outsourced analytical activities at CMOs
  • Experience and expertise in the release and stability testing of monoclonal antibodies and/or fusion proteins; bioconjugates or small molecule analytical expertise is a plus


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