Associate, Patient Materials Operations
Bristol-Myers Squibb
- Location
- Summit West - NJ - US
- Work model
- On-Site
- Level
- Entry
- H-1B history
- 57 approvals (FY2023)
- Posted
- 17h ago
About this role
Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes 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 .
Job Description
At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here at BMS with our Cell Therapy team. 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. 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. Shift Available: Thursday-Saturday and alternating Wednesdays 05:00-17:30 Responsibilities: Performs tasks for Cell Therapy products to support product Value Stream outputs according to Current Good Manufacturing Practices (cGMP’s) following the current, approved Standard Operating Procedures (SOPs) and Work Instructions (WIs). Maintains timing according to the production schedule to ensure on-time logistics. Performs apheresis receipt of patient materials and prepares final product shipments for couriers. Executes receipt and discard of ex-US Peripheral Blood Mononuclear Cells (PBMC) and ex-US Cryopreserved Material (CMAT). Supports Sample Retrieval, Sample Movements, and Sample Storage. Supports transfers of Manufactured Goods to off-site facility. Supports manual and electronic batch record executions, deviation investigations, and closure of CAPAs. 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. Work with management to ensure adequately trained personnel are available to perform all manufacturing activities. Records patient material handling data and information in a clear, concise, format according to proper GDPs. Able to problem solve with minimal supervision. Works in a team based, cross-functional environment to complete tasks required by shift schedule. Must be able to work in an environment with blood derived components. Other duties may be assigned, as necessary. Performs other tasks as assigned. Available to work OT when business requires. Willing to work staggered day shift hours. Knowledge & Skills: 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. Basic