Senior Director of Analytical Development
vor 1 Woche
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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