Executive Leader, Analytical Development
Vor 3 Tagen
Job Title: Associate Director, Process Analytics
About the Role:
We are seeking a seasoned Associate Director, Process Analytics, to lead our HPLC applications and oversee the development, transfer, and validation of HPLC test methods for the release testing of monoclonal antibodies, fusion proteins, and bioconjugates in preclinical to late-stage development.
Key Responsibilities:
- Develop, transfer, and validate HPLC test methods for internal and external use
- Support non-HPLC related analytical test methods
- Contribute to regulatory interactions and content of regulatory documents (IND, IMPD, briefing packages, BLA)
- Establish effective working relationships within the Biologics CMC team and with other Kodiak functions
Requirements:
- Master or Ph.D. in a relevant area (Biochemistry, Biotechnology, or Biological Sciences)
- 5-10 years of industrial Analytical Development and/or Quality Control experience
- Strong appreciation and experience in HPLC techniques
- Experience in managing outsourced analytical activities at CMOs
- Experience and expertise in 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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