(Night 6pm-6am) Manager, Cell Therapy Manufacturing

at  BristolMyers Squibb

WORKING WITH US

Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
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. Read more: careers.bms.com/working-with-us .

REQUIRED COMPETENCIES: KNOWLEDGE, SKILLS, AND ABILITIES:

Education:

• Bachelors in relevant science or engineering discipline, or equivalent in work experience.

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.

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 oversee 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.
  If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.