Manufacturing Associate, Liso-cel CAR-T

About the role

Specialist, Value Steam Cryo Operations is responsible for the Cryopreservation, movement, storage, control of manufacturing patient materials, and support of Liquid Nitrogen storage tanks and equipment at the CAR T manufacturing facility in Summit, NJ.

Responsibilities

• Handling patient material throughout the material Cryopreservation, storage, distribution, transfer, and disposal.
• Maintaining sample tracking and chain of custody records in accordance with GMP requirements and written procedures.
• Ensuring that obsolete or expired samples and materials are destroyed and disposed of according to written procedures.
• Performing sample queries and periodic storage reports, as required.
• Assisting management with investigations and deviations related to sample management.
• Collaborating with other departments to identify and implement process efficiencies.
• Maintaining metrics for the Value Stream Cryo Operations group.
• Facilitating cold chain transfers of material, as required.
• Supporting manual and electronic batch record executions, deviation investigations, and closure of CAPAs.
• Maintaining timing according to the production schedule to ensure on-time logistics.
• Recording patient material handling data and information in a clear, concise, format according to proper GDPs.
• Able to problem solve with minimal supervision.
• Work in a team-based, cross-functional environment to complete tasks required by shift schedule.

Requirements

• Experience with cold chain sample storage and transfer.
• Knowledge of cGMP/FDA regulated industry.
• Basic mathematical skills.
• General understanding of cGMPs.
• Technical writing capability.
• Proficient in MS Office applications.
• Inventory control and/or management.
• Background to include an understanding of biology, chemistry, medical or clinical practices.

Skills

• Knowledge of cGMP/FDA regulated industry.
• Basic mathematical skills.
• General understanding of cGMPs.
• Technical writing capability.
• Proficient in MS Office applications.
• Inventory control and/or management.
• Background to include an understanding of biology, chemistry, medical or clinical practices.

Qualifications

• Bachelor’s degree.
• Or Associate/ Medical Technical degree and 0-2 years of Manufacturing or Operations experience.
• Or High School diploma/GED and 2-4 years of Manufacturing or Operations experience.

Benefits

At Bristol Myers Squibb, we recognize 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.

Pay

Summit West - NJ - US: $27.83 - $33.72 per hour

Schedule

Shift Available: Wednesday - Saturday (with e/o Wednesday off), Onsite Day Shift, 5.00 a.m. - 5:30 p.m.