NIGHT SHIFT: Manager, Cell Therapy Manufacturing in Devens, MA

Role Summary

The Manager of Cell Therapy Manufacturing at Bristol Myers Squibb's Devens, MA facility leads start-up and commercial licensure activities for the cell therapy site. Oversees 24/7 manufacturing operations and manages manufacturing associates, ensuring compliance with cGMP, quality, and safety. This role requires night-shift leadership (6pm–6am) with a rotating schedule including holidays and weekends.

Responsibilities

• Manage the creation, implementation and compliance for all documentation, procedures and policies
• Operate within the requirements of validated manufacturing systems; plan, assign and oversee daily operational activities associated with assigned areas of responsibility
• 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 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 that embraces safety in the work environment and the safety of the patients by compliance with company procedures and policies, and cGMP requirements
• Efficiently coordinate, communicate, and provide 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 a daily basis, including:
  • 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
  • Assist in the setup of manufacturing areas and equipment/fixtures and perform facility and equipment commissioning, qualification and validation activities
  • Writing 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
• This position will require shift work, including holidays and weekends
• This position will require you to work in a clean room environment, with exposure to human blood components and in close proximity to strong magnets

Qualifications

• Required: Bachelors in relevant science or engineering discipline, or equivalent in work experience
• Required: 5+ years of experience in cGMP biologics cell culture manufacturing
• Preferred: Cell therapy manufacturing
• Preferred: Aseptic processing in ISO 5 biosafety cabinets and universal precautions for handling human derived materials in BSL-2 containment areas
• Preferred: Cell expansion using incubators and single-use bioreactors, cell washing processes, cell separation techniques and cryopreservation processes and equipment

Skills

• Advanced ability to accurately and completely understand, follow, interpret and apply global regulatory and cGMP requirements
• Demonstrated advanced technical writing skills
• Advanced strategic thinking and problem-solving ability/mentality, technically adept and logical
• Ability to work independently in a fast-paced team environment, meet deadlines, and prioritize work from multiple projects
• Advanced ability to communicate and collaborate effectively with peers, senior management and cross-functional peers about task status, roadblocks and needs, locally and globally
• Advanced mentoring, coaching, influencing, negotiating and personnel interaction skills