Associate Patient Material Operations

About the role

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

• Thursday - Saturday with Alternating Wednesdays 1500-0330

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
• 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
• 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 Requirements

• High School Diploma required. Bachelor's or associate degree preferred
• 0-1 years of cGMP cell therapy manufacturing, bioprocessing manufacturing, or relevant experience

Pay

• $27.83 - $33.72 per hour (Summit West - NJ - US)

Benefits

Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/. Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment.

Health Coverage: Medical, pharmacy, dental, and vision care.

Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).

Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.

Work-life Benefits:

• US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)
• Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
• Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day
• All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown

Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.

This response is AI-generated, for reference only.