Associate Director, Process Analytics
vor 3 Monaten
Associate Director, Process Analytics (HPLC)
Technical Operations, Quality & Manufacturing Visp, Switzerland
Description
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 Apply Apply Later Back to current listings
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