NIGHTS, Specialist, Lead Manufacturing Associate, Cell Therapy in Summit, NJ

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.

At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here at BMS with our Cell Therapy team.

The Specialist, Lead Manufacturing Associate, Cell Therapy manufactures human blood derived components per Standard Operating Procedures (SOPs) in a controlled, cGMP cleanroom environment under the supervision of Manufacturing Management. Manufacturing Associates adhere to regulatory requirements while performing job functions. Job duties are performed within a team according to an assigned, production shift schedule. Communication of production deviations and assistance with quality

investigations are required, as applicable.

Shifts Available:

Breyanzi Activation - Quad 2 (Night Shift)

Responsibilities:

• Oversee set-up and operation of equipment to support production of blood component lots through culture expansion, cell counting, data entry and media addition while maintaining good aseptic technique.
• Lead deviation investigations and write ups as needed. Accountable for on time closure of any assigned CAPAs within the designated shift.
• Good aseptic technique is required for most activities: tube welding, connections, and transfers, at minimum.
• Weigh and measure in-process materials to ensure proper quantities are added/removed.
• Adheres to the production schedule ensuring on-time, internal production logistics.
• Records production data and information in a clear, concise, format according to proper GDPs.
• Perform all tasks in a manner consistent with site safety policies, quality systems, and GMP requirements.
• Works in a team based, cross-functional environment to complete production tasks required by shift schedule.
• Must be highly motivated, team oriented with strong patient focus to fulfill job requirements.
• Is a SME and qualified trainer within a designated function of manufacturing. Team Lead is responsible for the designated area within the shift. Shift supervision will be managed by the shift Supervisor, but Team Lead will act as Supervisor when needed.
• Maintain on time completion of training assignments and those of the associates in the designated area to ensure the necessary technical skills and process knowledge required to execute operations in a GMP compliant manner.
• Lead shift daily review and correction of all logbooks in the processing suites.
• Performs other tasks as assigned: Lead continuous improvement projects, inspection readiness, right first-time initiatives, etc.
• Issue pre/post shift reports and escalate issues for timely resolution.

Knowledge & Skills:

• Advanced understanding of cell culture, cell expansion and aseptic processing or lab techniques within a cleanroom.
• Familiarity with Lean Manufacturing initiatives
• Knowledge of cGMP/FDA regulated industry requirements
• Basic mathematical skills
• Technical writing capability to support batch record revisions, deviation investigations, and closure of CAPAs.
• Proficient in MS Office applications
• Background to include an understanding of biology, chemistry, medical or clinical practices
• Must be a Qualified Trainer in Expansion Operations with ability and wil