Senior Director, Manufacturing Science and Technology, Cell Therapy Technical Operations

Role: Senior Director of Manufacturing Science and Technology (MSAT) leading global cell therapy manufacturing processes from tech transfer through commercialization and lifecycle management. Responsibilities: develop and execute MSAT strategy, build and mentor a high-performing team, oversee process validation, process improvements, and lifecycle optimization; represent MSAT in technology transfer, process characterization, and regulatory interactions; ensure process robustness, cost efficiency, and supply continuity; author and defend CMC regulatory submissions, support audits, and maintain cGMP compliance. Requirements: B.S., M.S., or Ph.D. in relevant engineering or biological sciences; 12+ years in cell therapy or biologics manufacturing, with expertise in process validation, regulatory filings, and GMP operations; proven leadership experience in technical development and cross-functional teams. HighValue: extensive background in cell therapy biologics manufacturing, process validation, and regulatory submissions; experience with biologics, viral vectors, or vaccines; involvement in IND, BLA, MAA filings; leadership in technical strategy and global team management. WorkSetup: on-site with flexible work arrangements; no specific travel mentioned.