Manager, Cell Therapy Manufacturing - Devens MA
About The Position
The Manager, Cell Therapy Manufacturing supports the facility’s commercial operations and oversees personnel manufacturing clinical and commercial products. The role oversees shifts covering 24/7 cell therapy manufacturing unit operations, such as media preparation, cell selection, cell processing, and product fill, performed in accordance with current Good Manufacturing Practices (cGMPs). The manager plans and oversees daily operations in assigned areas, maintains compliant and safe operating and storage spaces, and leads responses to operational issues, deviations, corrective and preventive actions, and investigations. The role coordinates operational project information and status with Planning, Manufacturing, Quality Assurance/Operations, Global Supply, and other functions. It also supervises operators, supports training and qualification activities, and hires, mentors, develops, and reviews manufacturing associates. The position requires shift work, including holidays and weekends, and work in a clean room with exposure to human blood components and close proximity to strong magnets.
Requirements
- At least 5 years of experience in cGMP bioprocessing manufacturing, cell therapy manufacturing, or relevant experience.
- Bachelor’s degree in a relevant science or engineering discipline, or equivalent work experience.
Nice To Haves
- Experience with cell therapy manufacturing techniques, including cell washing, cell separation, cryopreservation, cell expansion using incubators and bioreactors, and automated equipment.
- Experience with aseptic processing in ISO 5 biosafety cabinets and universal precautions for handling human-derived materials in BSL-2 containment areas.
Responsibilities
- Support the development, implementation, and compliance of manufacturing documentation, procedures, and policies.
- Plan, assign, and oversee daily operational activities in assigned areas in accordance with validated manufacturing systems.
- Maintain operating and storage areas that are compliant, efficient, effective, and safe.
- Identify strategic and operational issues to prevent deviations and maintain a compliant environment.
- Lead the development of corrective and preventive actions, deviation responses, and investigations.
- Promote teamwork, open communication, and a sense of urgency.
- Foster a culture of safety and compliance, including compliance with company procedures, policies, and cGMP requirements.
- Coordinate and communicate Operations project information and activity status to Planning, Manufacturing, Quality Assurance/Operations, Global Supply, and other associated functions according to schedules and implementation timelines.
- Oversee operators performing unit and support operations according to standard operating procedures and batch records in a safe, GMP-compliant manner.
- Oversee completion of documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records.
- Maintain training assignments to ensure personnel have necessary technical skills and knowledge.
- Oversee setup of manufacturing areas and equipment or fixtures, and facility and equipment commissioning, qualification, and validation activities.
- Hire, mentor, and develop manufacturing personnel.
- Conduct performance reviews and identify career-growth opportunities for manufacturing associates.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
