Manufacturing Manager, Cell Therapy Facility

Bristol-Myers Squibb - Devens, MA

Full-time - Senior

Hybrid - Devens, MA

Chemical Manufacturing

About the position

The Manufacturing Manager for the Cell Therapy Facility at Bristol-Myers Squibb will oversee the start-up and commercial licensure of a new manufacturing facility in Devens, MA. This role is critical in managing 24/7 cell therapy operations and ensuring compliance with cGMP standards while leading a team of manufacturing associates. The position emphasizes the importance of safety, teamwork, and effective communication in a high-stakes environment that directly impacts patient care.

Responsibilities

• Manage the creation, implementation, and compliance for all documentation, procedures, and policies.
• Operate within the requirements of validated manufacturing systems, planning, assigning, and overseeing daily operational activities.
• Maintain compliant, efficient, effective, and safe operating and storage areas.
• Identify strategic and operational issues to prevent deviations and maintain a compliant environment.
• Lead and manage the development of corrective and preventative actions, deviation responses, and investigations.
• Manage implementation and maintenance of appropriate training curricula.
• Create an environment of teamwork, open communication, and a sense of urgency.
• Foster a culture of safety and compliance in accordance with company procedures and cGMP requirements.
• Coordinate and communicate Operations project information and activities status to associated functions in a timely manner.
• Oversee operators performing unit operations and support operations in a safe and GMP compliant manner.
• Assist in the setup of manufacturing areas and equipment, performing facility and equipment commissioning, qualification, and validation activities.
• Write manufacturing operating procedures that comply with cGMP requirements and promote effective operations.
• Hire, mentor, and develop manufacturing associates, conducting performance reviews and identifying growth opportunities.

Requirements

• Bachelor's degree in a relevant science or engineering discipline or equivalent work experience.
• 5+ years of experience in cGMP biologics cell culture manufacturing.
• Experience in cell therapy manufacturing is highly preferred.
• Knowledge of aseptic processing in ISO 5 biosafety cabinets and handling human-derived materials in BSL-2 containment areas.
• Experience with cell expansion using incubators and single-use bioreactors, cell washing processes, cell separation techniques, and cryopreservation processes.

Nice-to-haves

• Experience in clinical trials related to cell therapy.
• Familiarity with regulatory compliance in a manufacturing environment.

Benefits

• Competitive salary and benefits package.
• Opportunities for career growth and development.
• Support for work-life balance and flexibility.