Director, Upstream Cell Culture Process Development and Manufacturing (Biologics)
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About The Position
We are seeking an experienced and motivated candidate to lead early-stage IND enabling cell line and cell culture process development and manufacturing activities. In this role, the ideal candidate will be responsible for overseeing cell line and process development, tech transfer, scale-up and clinical DS manufacturing of monoclonal antibodies at the CDMOs. The successful candidate will establish CMC strategy for early-stage process development, perform gap assessment, and provide timely solutions while continuing to plan late-stage development. In this role, you will oversee activities at the CDMO partners to track and ensure timely completion of GMP drug substance manufacturing. This role involves drafting high quality reports, finalization of source documents and active participation in writing regulatory submissions. You will be an integral part of the team with an opportunity to work in a fast-paced environment.
