Associate, Patient Materials Operations, MSS

Overview

Associate, Patient Materials Operations supports patient material needs for CAR-T production under SOPs in controlled environments, under supervision of Patient Materials Operations Management. role requires adherence to regulatory requirements. The position involves working in a team with a shift schedule and communicating deviations and supporting quality investigations. Onsite Day Shift, Monday – Friday, 8:00 a.m. – 4:30 p.m.

• Perform tasks for Cell Therapy products to support product Value Stream outputs according to cGMPs, current SOPs and Work Instructions.
• Maintain timing according to the production schedule to ensure on-time logistics.
• Perform apheresis receipt of patient materials and prepare final product shipments for couriers.
• Execute receipt and discard of ex-US PBMCs and ex-US CMAT.
• Support Sample Retrieval, Sample Movements, and Sample Storage.
• Support transfers of Manufactured Goods to off-site facility.
• Support manual and electronic batch record executions, deviation investigations, and CAPA closures.
• Ensure all documentation is correct and address procedural/documentation errors expeditiously and effectively.

• Work with management to ensure adequately trained personnel are available to perform all manufacturing activities.
• Record patient material handling data in a clear, concise format according to GDP standards.
• Able to problem solve with minimal supervision and work in a cross-functional team.
• Ability to work in an environment with blood-derived components and overtime as required.
• Willing to work staggered day shift hours.

• High School Diploma required;
  Bachelor’s or Associate degree preferred.
• 0–1 year of cGMP cell therapy manufacturing, bioprocessing manufacturing, or relevant experience.

Location:

Summit West, NJ, US. Compensation: $28.13 – $34.09 per hour for full-time employment; additional incentive cash and stock opportunities may be available. Final compensation determined based on experience. Benefits and eligibility details are provided on the careers site.

Other notes:
On-site protocol and BMS policies apply. This role may be onsite or hybrid depending on site requirements and occupancy type.