About the position
As a Manufacturing Associate II in Cell Therapy at Bristol Myers Squibb, you will engage in meaningful and life-changing work that directly impacts the lives of patients. This role is centered around the execution of cell therapy manufacturing operations, where you will be responsible for performing patient process unit operations and supporting operations as outlined in standard operating procedures and batch records. You will be expected to demonstrate strong practical and theoretical knowledge in your work, ensuring that all tasks are completed in compliance with safety policies, quality systems, and Good Manufacturing Practices (GMP) requirements. Your responsibilities will include completing documentation required by process transfer protocols, validation protocols, and batch records, as well as collaborating with support groups to recommend and solve technical and operational problems. You will also assist in setting up manufacturing areas and equipment, perform facility and equipment commissioning activities, and train others on standard operating procedures (SOPs) and work instructions to ensure successful completion of manufacturing operations. The role requires you to execute a daily unit operations schedule that includes managing people, product, and material flow across multiple shifts. Working in a cleanroom environment, you will perform aseptic processing and maintain manufacturing environmental conditions according to global Health Authority requirements. This position demands a driven and motivated individual who is willing to learn and execute cell therapy manufacturing operations, with the ability to work assigned shifts, including days, nights, weekends, and holidays. You will also be exposed to human blood components and must be comfortable working in close proximity to strong magnets.
Responsibilities
- Performing patient process unit operations and support operations described in standard operating procedures and batch records.
- Completing documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records.
- Performing tasks in a manner consistent with the safety policies, quality systems, and GMP requirements.
- Completing training assignments to ensure the necessary technical skills and knowledge.
- Collaborating with support groups on recommendations and solving technical and operational problems.
- Identifying innovative solutions.
- Assisting in setting up manufacturing areas and equipment/fixtures.
- Performing facility and equipment commissioning activities.
- Training others on SOPs, Work Instructions to successfully complete manufacturing operations.
- Executing daily unit operations schedule that includes people, product, and material flow across multiple shifts.
- Maintaining manufacturing environmental conditions by performing area disinfection regiment as required.
Requirements
- High school diploma and 2+ years of experience in cGMP bioprocessing manufacturing, cell therapy manufacturing or relevant experience.
- Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing is preferred.
- Ability to work assigned shift (Day, Night, Weekends and/or Holidays).
- Ability to work in a cleanroom environment and perform aseptic processing.
- Comfortable being exposed to human blood components.
- Ability to be in close proximity to strong magnets.
Nice-to-haves
- Experience in cell therapy manufacturing, including cell washing processes and automated equipment.
- Experience with cell separation techniques and automated equipment.
- Experience with cryopreservation processes and equipment.
- Aseptic processing in ISO 5 biosafety cabinets.
- Universal precautions for handling human derived materials in BSL-2 containment areas.
Benefits
- Competitive benefits, services, and programs to support employee goals.
- Opportunities for career growth and development.
