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PURPOSE AND SCOPE OF POSITION:

BMS is seeking a Manager of Cell Therapy Manufacturing for a new manufacturing facility in Devens, MA. The Manager will support the start-up and commercial licensure of the Cell Therapy facility. This Manager will be responsible for shifts that cover 24/7 cell therapy operations and will manage manufacturing associates.

DUTIES AND RESPONSIBILITIES:

• Manage the creation, implementation and compliance for all documentation, procedures and policies
• Operate within the requirements of a 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 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.
  • 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.

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:

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

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Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.

Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.

To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

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