Senior Director, Analytical Operations
vor 1 Woche
Role Overview
We are seeking an experienced Associate Director to oversee HPLC applications, including test method development, transfer, and validation for the release testing of monoclonal antibodies, fusion proteins, and antibody-biopolymer conjugates in preclinical to late-stage development.
Key Responsibilities
- Oversee and manage the development, transfer, and validation of HPLC test methods both internally and externally.
- Support non-HPLC related analytical test methods.
- Contribute to regulatory interactions and assist in the content of regulatory documents, such as IND, IMPD, briefing packages, and BLA as needed.
- 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 with 5-10 years of industrial Analytical Development and/or Quality Control experience.
- Strong and thorough appreciation and experience in HPLC techniques.
- Experience in managing outsourced analytical activities at Contract Manufacturing Organizations (CMOs).
- Experience and expertise in the release and stability testing of monoclonal antibodies and/or fusion proteins, with bioconjugates or small molecule analytical expertise being a plus.
- Demonstrated ability to function in a collaborative and 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 and oral communication skills in English and German.
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