Associate Patient Materials Operations - Cell Therapy
Overview
You will own the receipt, handling, and shipment of patient materials for CAR-T production at Bristol Myers Squibb, ensuring compliance with cGMP and FDA regulations. You will join the Cell Therapy team in Summit, NJ, working on a set shift schedule (Thursday-Saturday and alternating Wednesdays, 15:00-03:30). This role offers the chance to contribute to life-changing therapies while developing expertise in cell therapy manufacturing operations.
What You'll Do10
- 1Perform tasks for Cell Therapy products to support value stream outputs according to current cGMP standards and SOPs.
- 2Maintain timing per production schedule to ensure on-time logistics for patient materials.
- 3Perform apheresis receipt of patient materials and prepare final product shipments for couriers.
- 4Execute receipt and discard of ex-US PBMC and Cryopreserved Material.
- 5Support sample retrieval, sample movements, and sample storage.
- 6Support transfers of manufactured goods to off-site facilities.
- 7Execute manual and electronic batch records, investigate deviations, and close CAPAs.
- 8Record patient material handling data accurately per GDP principles.
- 9Work with management to ensure adequate training of personnel for manufacturing activities.
- 10Problem solve with minimal supervision in a team-based, cross-functional environment.
Requirements10
- 1High School Diploma required; Bachelor's or associate degree preferred.
- 20-1 years of cGMP cell therapy manufacturing, bioprocessing, or relevant experience.
- 3Experience with cold chain sample storage and transfer.
- 4Knowledge of cGMP/FDA regulated industry.
- 5Basic mathematical skills and general understanding of cGMP.
- 6Technical writing capability.
- 7Proficient in MS Office applications.
- 8Inventory control and/or management background.
- 9Understanding of biology, chemistry, medical, or clinical practices.
- 10Ability to work with blood-derived components and on assigned shift including overtime.
Salary Insight
Salary not disclosed in listing
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