Aseptic Control Principal Scientist, MSAT

Role: Principal Scientist, Aseptic Control, providing technical expertise in sterile and low bioburden processing for cell and gene therapy, small molecule, and combination device manufacturing within cGMP facilities. Responsibilities: develop and support microbial control strategies, monitor and investigate aseptic processing deviations, support regulatory submissions, collaborate on process development for aseptic filling technologies, and establish post-approval control monitoring. Requirements: 10+ years of experience in aseptic drug product development or manufacturing, strong knowledge of sterile processing, microbial testing, and contamination control, expertise with biologics or cell therapies, and a background in microbiology or engineering. HighValue: biologics and cell therapy modalities, late-phase to commercial manufacturing, contamination risk management, regulatory compliance, and aseptic process technologies including simulations and facility monitoring. Collaboration reports to the Director of Aseptic Control, with internal and external manufacturing interface. Work setup: hybrid in Boston, MA, with some on-site presence; flexible working arrangements.