August 13, 2024

Kodiak Sciences Inc.

Visp

OTHER

Associate Director, Process Analytics (HPLC)

We are seeking an Associate Director, Process Analytics, to oversee HPLC applications like 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. To successfully execute this role, a strong scientific approach, analytical expertise, and QC experience are required. The ideal candidate has a track record of establishing mutual respect, trust, close collaborations with internal and external organizations, and the ability to interact effectively at all levels. The role is well suited for an individual with tremendous intellectual curiosity and a “can-do attitude.” This position will report to the Director, Process Analytics.

Responsibilities

Oversee and manage the development, transfer and validation of HPLC test methods taking place internally and/or externally
Opportunity to support non-HPLC related analytical test methods
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

Education/Experience

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
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