Manufacturing Team Lead, Liso-cel CAR-T, Manufacturing Operations

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits.

This is work that transforms the lives of patients, and the careers of those who do it.

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.

Our Manufacturing Team Lead, Liso-cel CAR-T, Manufacturing manufactures human blood derived components per Batch Record and Standard Operating Procedures 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.

Shift Available:

• Wednesday - Saturday (with e/o Wednesday off), Onsite Night Shift, 5 p.m.
  
  - 5:30 a.m.

Responsibilities:

• Oversee set-up and operation of equipment to support production of blood component lots through cell culture, harvest, and cryopreservation.
• Lead deviation investigations and write ups as needed.
• Accountable for on time closure of any assigned CAPAs within the designated shift.
• Aseptic technique is required for tube most activities: welding, connections, and transfers, at minimum.
• Aseptic qualification is required.
• Weighs and measures 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.
• Motivated, team consciousness individuals are needed 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.
• Performs other tasks as assigned:
  Lead continuous improvement projects, inspection readiness, right first-time initiatives, etc.

Knowledge &

Skills:

• Basic understanding of cell culture, cryopreservation, purification, and aseptic processing or lab technique.
• Knowledge of cGMP/FDA regulated industry.
• Basic mathematical skills.
• General understanding of cGMPs.
• Technical writing capability.
• Proficient in MS Office applications.
• Background to include an understanding of biology, chemistry, medical or clinical practices.

Minimum Requirements:

• Pre-requisites:
  Must be a Senior Associate in Cell Therapy Manufacturing.
• Bachelor’s degree and 2-4 years of…