Senior Director, Analytical Development
vor 4 Wochen
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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