Manager, Cell Therapy Manufacturing in Devens, MA
About The Position
Bristol Myers Squibb is reimagining the future of cell therapy and is seeking a Manager, Cell Therapy Manufacturing to support commercial operations. This role is responsible for overseeing personnel involved in manufacturing both clinical and commercial products, with shifts covering 24/7 operations. The position involves managing unit operations such as media preparation, cell selection, cell processing, and product fill, all in compliance with Current Good Manufacturing Practices (cGMP). The Manager will support the development, implementation, and compliance of manufacturing documentation, procedures, and policies. They will operate within validated manufacturing systems, plan and oversee daily operational activities, and ensure manufacturing areas are compliant, efficient, effective, and safe. A key aspect of the role is identifying and preventing deviations, leading corrective and preventative actions, and fostering a culture of teamwork, open communication, safety, and compliance. The Manager will also coordinate and communicate project information to various functions and oversee operators in performing unit operations, completing documentation, and maintaining training. Additionally, the role includes assisting with manufacturing area setup, equipment commissioning, qualification, and validation, as well as writing sound manufacturing operating procedures and developing exceptional people through hiring, mentoring, and performance reviews.
Requirements
- Bachelors 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.
Nice To Haves
- 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 is highly preferred.
- Experience with aseptic processing in ISO 5 biosafety cabinets, universal precautions for handling human derived materials in BSL-2 containment areas is highly preferred.
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.
- Leading and managing the development of corrective and preventative actions, deviation responses and investigations.
- 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.
- 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
- Hiring, mentoring and developing exceptional people
- Conducting performance reviews and identifying opportunities for career growth for manufacturing associates.
Benefits
- Medical, pharmacy, dental, and vision care.
- BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
- 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
- Flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees))
- 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
- Unlimited paid sick time
- Up to 2 paid volunteer days per year
- Summer hours flexibility
- Leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs
- Annual Global Shutdown between Christmas and New Years Day.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Manager
Number of Employees
5,001-10,000 employees
