Senior Director of Analytical Development

vor 1 Woche


Visp, Schweiz Kodiak Sciences Vollzeit

Senior Director of Analytical Development

Kodiak Sciences is seeking a Senior Director of Analytical Development to oversee the development, transfer, and validation of HPLC test methods.

Key Responsibilities:

  • Manage the development, transfer, and validation of HPLC test methods
  • Support non-HPLC related analytical test methods
  • Contribute to regulatory interactions and content of regulatory documents
  • Establish effective working relationships within the Biologics CMC team and with other Kodiak functions

Requirements:

  • Master or Ph.D. in a relevant area with 5-10 years of industrial Analytical Development and/or Quality Control experience
  • Strong 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
  • Demonstrated ability to function in a collaborative/team-oriented CMC environment
  • Excellent written/oral communication skills in English and German


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