Manager, Cell Therapy Manufacturing in Devens, MA

About the role

Supports the commercial operations of the facility. Responsible for the people manufacturing both clinical and commercial product with oversight of shifts covering 24/7 cell therapy manufacturing unit operations.

Responsibilities

• Supporting the development, implementation and compliance of manufacturing documentation, procedures, & policies.
• Operating within the requirements of a validated manufacturing systems, plan, assign and oversee daily operational activities associated with assigned areas of responsibility.
• Maintaining operating and storage areas that are compliant, efficient, effective and safe.
• Identifying strategic and operational issues to prevent deviations and maintain a compliant environment.
• Create an environment of teamwork, open communication, and a sense of urgency.
• Foster a culture of safety and compliance that embraces safety in the work environment and the safety of the patients by compliance with company procedures and policies, and cGMP requirements.
• Efficiently coordinating, communicating, and providing Operations project information and activities status to Planning, Manufacturing, Quality Assurance / Operations, Global Supply and other associated functions in a timely manner in accordance to schedules and defined implementation timelines.
• Oversee operators on daily basis as they:
  • Perform unit operations and support operations described in standard operating procedures and batch records in a safe and GMP compliant manner.
  • Complete documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records.
  • Maintain training assignments to ensure the necessary technical skills and knowledge.
  • Absorb and perform facility and equipment commissioning, qualification and validation activities.
  • Write manufacturing operating procedures that are technically sound, promote effective and efficient operations, and comply with cGMP requirements.
  • Hire, mentor and develop exceptional people.
  • Conduct performance reviews and identify opportunities for career growth for manufacturing associates.

Requirements

• Bachelor's in relevant science or engineering discipline, or equivalent in work experience.
• 5+ years of experience in cGMP bioprocessing manufacturing, cell therapy manufacturing or relevant experience.
• Experience in cell therapy manufacturing techniques, including cell washing processes, cell separation processes, cryopreservation processes, cell expansion processes, using incubators and bioreactors, and automated equipment.
• Experience with aseptic processing in ISO 5 biosafety cabinets, universal precautions for handling human derived materials in BSL-2 containment areas.

Qualifications

• Basic qualifications: Bachelor's degree in relevant science or engineering discipline, or equivalent work experience.
• Experience: 5+ years in cGMP bioprocessing manufacturing, cell therapy manufacturing or relevant experience.
• Specific qualifications: Experience in cell therapy manufacturing techniques, including cell washing processes, cell separation processes, cryopreservation processes, cell expansion processes, using incubators and bioreactors, and automated equipment.
• Additional qualifications: Experience with aseptic processing in ISO 5 biosafety cabinets, universal precautions for handling human derived materials in BSL-2 containment areas.

Skills

• Strong leadership and management skills.
• Excellent organizational and problem-solving abilities.
• Ability to work independently and as part of a team.
• Strong communication and interpersonal skills.
• Knowledge of cGMP requirements and regulations.
• Experience with aseptic processing and cell therapy manufacturing techniques.

Benefits

Read more: careers.bms.com/working-with-us

Pay

$104,975 - $127,205

Schedule

TBD