Scientist, QC Microbiology, Cell Therapy

Role: QC Microbiology Scientist supporting cell therapy manufacturing, specializing in method transfer, validation, and routine testing of in-process, final, and stability samples. Responsibilities include data review, complex troubleshooting, training, documenting deviations and CAPAs, and contributing to continuous improvement. The role may represent the department during regulatory inspections and involves cross-training on microbiology methods. Requirements include a Bachelor's in science with 6+ years in microbiological testing or QC, proficiency in microbiological techniques, and knowledge of GMP and regulatory standards. Preferred skills encompass technical writing and experience with LIMS and ELN systems. High-value specifics involve cell therapy modalities, with a focus on biologics development, and participation in regulated environments. The position may involve routine collaboration with cross-functional teams and requires on-site work at Devens, MA, with some roles allowing hybrid work; travel is not explicitly specified.