Associate, Patient Materials Operations, MSS

Associate, Patient Materials Operations – Cell Therapy

The Associate, Patient Materials Operations is responsible for handling patient material needs/requirements for CAR‑T production per Standard Operating Procedures (SOPs) in controlled and/or classified environments under the supervision of Patient Materials Operations Management. The Specialist must 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.

Job : R1603383.

Sunday – Wednesday (with every other Wednesday off) – Onsite Day Shift, 5:00 a.m. – 5:30 p.m.

• Perform tasks for Cell Therapy products to support product Value Stream outputs according to Current Good Manufacturing Practices (cGMPs) following approved Standard Operating Procedures (SOPs) and Work Instructions (WIs).
• 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 Peripheral Blood Mononuclear Cells (PBMC) and ex‑US Cryopreserved Material (CMAT).
• Support Sample Retrieval, Sample Movements, and Sample Storage.
• Support transfers of Manufactured Goods to off‑site facilities.
• Support manual and electronic batch record executions, deviation investigations, and closure of CAPAs.
• Ensure all documentation is correct and addresses 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 and information in a clear, concise format according to proper GDPs.
• Problem‑solve with minimal supervision.
• Work in a team‑based, cross‑functional environment to complete tasks required by the shift schedule.
• Work in an environment with blood‑derived components.
• Be available to work overtime when business requires.
• Be willing to work staggered day shift hours.
• Other duties may be assigned as necessary.

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

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

Compensation Overview:
Summit West - NJ - US: $28.13 – $34.09 per hour. Additional incentive cash and stock opportunities (based on eligibility) may be available. Final, individual compensation will be decided based on demonstrated experience.

• Medical, pharmacy, dental, and vision coverage.
• Well‑being support programs and employee assistance programs.
• 401(k) plan and other retirement savings options.
• Short‑term and long‑term disability.
• Life insurance and accident insurance.
• Supplemental health insurance and business travel protection.
• Identity theft benefit, legal support, and survivor support.
• Paid time off, flexible time off, and paid national holidays.
• Unpaid and flexible volunteer days, summer hours flexibility, and leave options (medical, personal, parental, caregiver, bereavement, and military).
• Annual Global Shutdown between Christmas and New Years Day.

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