Lead Manufacturing Associate, Cell Therapy in Devens, MA

Bristol Myers Squibb seeks a Lead Manufacturing Associate for cell therapy operations at its Devens, MA facility. The role involves executing patient process unit operations, maintaining cleanroom and aseptic processing standards, and supporting GMP-compliant manufacturing on a rotating 6am–6pm shift schedule.

Responsibilities

• Execute patient process unit operations and support activities per SOPs and batch records
• Complete required documentation for process transfer, validation, and GMP compliance
• Maintain cleanroom environmental conditions through disinfection and viable/non-viable particulate monitoring
• Collaborate with manufacturing managers and cross-functional teams on operational scheduling and problem-solving
• Support development of manufacturing procedures and quality event investigations

Requirements

• 4+ years cGMP bioprocessing or cell therapy manufacturing experience
• Bachelor's degree in relevant science/engineering or equivalent work experience
• Cell therapy manufacturing techniques including cell washing, separation, cryopreservation, and expansion
• Aseptic processing capability in ISO 5 biosafety cabinets
• Knowledge of cGMP regulations and FDA guidance for biologics and cell therapy
• Ability to work assigned shifts including nights, weekends, and holidays
• Comfort with human blood component exposure and proximity to strong magnets