Director of Analytical Development

vor 3 Wochen


Visp, Schweiz Kodiak Sciences Vollzeit
Job Title: Associate Director, Process Analytics

We are seeking a highly skilled and experienced Associate Director, Process Analytics 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.

Key Responsibilities:
  • Develop and manage the development, transfer, and validation of HPLC test methods taking place internally and/or externally.
  • Support non-HPLC related analytical test methods.
  • Contribute to regulatory interactions and 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.
  • Demonstrated ability to function in a collaborative/team-oriented CMC environment.
  • Able to demonstrate strong attention to detail while working under pressure.
  • Ability to communicate and connect with all levels of the organization.
  • Excellent written/oral communication skills in English and German.


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