Manager, Cell Therapy Manufacturing - Devens MA

Military Spouse Corporate Career Network•Devens, MA

1d•Onsite

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, in accordance with current Good Manufacturing Practices (cGMPs). The manager plans, assigns, and oversees daily operations in assigned areas within validated manufacturing systems; supports the development and compliance of manufacturing documentation, procedures, and policies; and maintains compliant, efficient, effective, and safe operating and storage areas. The role leads corrective and preventive actions, deviation responses, and investigations, and coordinates project information and activities with Planning, Manufacturing, Quality Assurance/Operations, Global Supply, and other functions. The position also oversees operators performing manufacturing and support operations, completing required documentation, maintaining training assignments, setting up manufacturing areas and equipment, and supporting commissioning, qualification, and validation activities. The manager hires, mentors, develops, and reviews manufacturing associates, identifying opportunities for their career growth. This is an on-site role in Devens, Massachusetts. The listed shift is 6 a.m. to 6 p.m. on a rotating schedule that includes holidays and weekends. Work includes clean-room activities, exposure to human blood components, and 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.
Experience with 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 while operating within 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 adherence to 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 accordance with 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.
Ensure operators complete documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records.
Ensure training assignments are maintained so staff have the necessary technical skills and knowledge.
Oversee setup of manufacturing areas, equipment, and fixtures, and facility and equipment commissioning, qualification, and validation activities.
Hire, mentor, and develop manufacturing staff.
Conduct performance reviews and identify career-growth opportunities for manufacturing associates.