Manager, Cell Therapy Manufacturing in Devens, MA
About The Position
The Manager, Cell Therapy Manufacturing supports the commercial operations of the facility and is responsible for the people manufacturing clinical and commercial products. The role oversees shifts covering 24/7 cell therapy manufacturing unit operations, including media preparation, cell selection, cell processing, and product fill, all performed in accordance with Current Good Manufacturing Practices (cGMPs). The manager oversees day-to-day manufacturing activities, compliance, staffing, and operational coordination. The position involves leading and developing manufacturing associates, maintaining safe and compliant work areas, supporting manufacturing documentation and systems, and coordinating with Planning, Manufacturing, Quality Assurance/Operations, Global Supply, and other functions. The role works a 6 a.m.–6 p.m. rotating schedule, including holidays and weekends. Work takes place in a clean room environment and involves 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 in 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.
- Operate within validated manufacturing systems and plan, assign, and oversee daily operational activities in assigned areas.
- 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 and manage corrective and preventative actions, deviation responses, and investigations.
- Create an environment of teamwork, open communication, and urgency, and foster a culture of safety and 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 in a timely manner and 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 associates have the necessary technical skills and knowledge.
- Assist with setup of manufacturing areas, equipment, and fixtures, and perform 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.
Benefits
- Comprehensive benefit plans, including wellbeing support, retirement and financial protection benefits, and medical, dental, vision, life, and disability insurance.
- Eligible U.S.-based exempt employees receive Flexible Time Off without a set accrual limit, subject to manager approval, and 11 paid company holidays annually.
- Eligible non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires, subject to manager approval, 11 paid company holidays, and 3 optional holidays.
- Depending on eligibility, additional time-off benefits may include paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leave for medical, personal, parental, caregiver, bereavement, or military needs.
- Eligible employees receive an annual Global Shutdown between Christmas Day and New Year's Day.
- Eligible for additional discretionary incentive cash and stock opportunities.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
