Manager, Cell Therapy Manufacturing β supports commercial operations of the facility and oversees 24/7 cell therapy manufacturing unit operations (media preparation, cell selection, cell processing, or product fill) executed in accordance with cGMP.
Responsibilities:
- Support development, implementation, and compliance of manufacturing documentation, procedures, and policies.
- Plan, assign, and oversee daily operational activities for assigned areas within validated manufacturing systems.
- Maintain compliant, efficient, effective, and safe operating/storage areas.
- Identify issues to prevent deviations; lead corrective/preventive actions, deviation responses, and investigations.
- Foster teamwork, open communication, safety and compliance culture for employees and patient safety via procedures/policies and cGMP.
- Coordinate and communicate operations project status to Planning, Manufacturing, QA/Operations, Global Supply, and others.
- Oversee operators: ensure safe/GMP-compliant unit operations and batch-record execution; complete required documentation; maintain training assignments; support setup and commissioning/qualification/validation; write manufacturing operating procedures compliant with cGMP.
- Hire, mentor, develop teams; conduct performance reviews and career-growth planning.
Working conditions:
- Shift work incl. holidays/weekends; clean room with exposure to human blood components and close proximity to strong magnets.
Basic requirements:
- Bachelorβs in relevant science/engineering (or equivalent experience).
- 5+ years cGMP bioprocessing manufacturing / cell therapy manufacturing.
- Preferred: cell therapy manufacturing techniques (washing, separation, cryopreservation, expansion; incubators/bioreactors; automated equipment).
- Preferred: aseptic processing in ISO 5 biosafety cabinets; universal precautions for BSL-2 human-derived materials.
Compensation/benefits (explicit): Devens, MA: $104,975β$127,205 plus possible incentive cash/stock. Health, wellbeing, financial protection benefits; paid time off (details by location/role).
Application instruction (explicit): If it doesnβt perfectly match your resume, apply anyway.