Manufacturing Associate, CAR-T Abecma CAR-T

About the role

Manufactures human blood derived components per Standard Operating Procedures (SOPs) in a controlled, cGMP cleanroom environment under the supervision of Manufacturing Management.

Purpose and Scope of Position: Manufactures human blood-derived cellular therapy products in accordance with SOPs and cGMP requirements. Performs cell culture maintenance and expansion, cell harvest, isolation and cryopreservation activities. Executes aseptic processing activities, including tube welding, sampling, cell counts, sterile connections, material transfers. Adheres to production schedules and supports on-time manufacturing operations. Supports manual and electronic batch record executions, deviation investigations, and CAPA closures. Maintains timing according to the production schedule to ensure on-time logistics. Ensures all documentation is correct and addresses procedural/documentation errors expeditiously and effectively. Works in a team-based, cross-functional environment to complete tasks required by shift schedule. Available to work overtime when business requires. Willing to work staggered day shift hours.

Responsibilities

• Manufacture human blood-derived cellular therapy products in accordance with SOPs and cGMP requirements.
• Perform cell culture maintenance and expansion, cell harvest, Isolation and cryopreservation activities.
• Execute aseptic processing activities, including: Tube welding, Sampling, cell counts, Sterile connections, Material transfers.
• Adhere to production schedules and support on-time manufacturing operations.
• Supports manual and electronic batch record executions, deviation investigations, and CAPA closures.
• Maintains timing according to the production schedule to ensure on-time logistics.
• Ensures all documentation is correct and addresses procedural/documentation errors expeditiously and effectively.
• Works in a team-based, cross-functional environment to complete tasks required by shift schedule.
• Available to work overtime when business requires. Willing to work staggered day shift hours.

Requirements

• Basic understanding of: Cell culture, Cryopreservation, Cell Expansion, Aseptic processing techniques, Laboratory techniques.
• Knowledge and understanding of cGMP and FDA-regulated manufacturing environments.
• Technical writing and documentation skills.
• Proficiency in Microsoft Office applications.
• Foundation knowledge of: Biology, Chemistry, Mathematics.
• Strong teamwork and communication skills.
• Ability to work effectively in a fast-paced manufacturing environment.
• Inventory control and/or management.

Skills

• Basic understanding of: Cell culture, Cryopreservation, Cell Expansion, Aseptic processing techniques, Laboratory techniques.
• Knowledge and understanding of cGMP and FDA-regulated manufacturing environments.
• Technical writing and documentation skills.
• Proficiency in Microsoft Office applications.
• Foundation knowledge of: Biology, Chemistry, Mathematics.
• Strong teamwork and communication skills.
• Ability to work effectively in a fast-paced manufacturing environment.
• Inventory control and/or management.

Benefits

Read more: careers.bms.com/working-with-us.

Pay

$27.83 - $33.72 per hour.

Schedule

Wednesday- Saturday (with e/o Wednesday off), Onsite Night Shift, 5 p.m. - 5:30 a.m. Times are subject to change based on business demands.