Clinical Manufacturing Associate II, Cell Therapy in Devens, MA
About the role
Bristol Myers Squibb is seeking a Clinical Manufacturing Associate II, Cell Therapy to join our dynamic team. This role is responsible for performing clinical patient process unit operations and supporting operations as outlined in standard operating procedures and batch records.
Responsibilities
- Performing Clinical patient process unit operations and supporting operations described in standard operating procedures and batch records.
- Completing documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records.
- Solving simple problems; taking new perspectives using existing solutions.
- Identifying innovative solutions.
- Executing daily unit operations schedule that includes people, product, and material flow across multiple shifts.
- Working in a cleanroom environment and performing aseptic processing; maintaining manufacturing environmental conditions (Non-Viable Particulate(s) and Viable microbial levels per controlled area classification specifications) by performing area disinfection regiment as required to meet global Health Authority requirements.
- Collaborating with support groups on recommendations and solving technical and operational problems.
- Assisting in setting up manufacturing areas and equipment/fixtures.
- Performing facility and equipment commissioning activities.
- Any related tasks as required to contribute to a new startup facility.
Requirements
- High school diploma and 2+ years of experience in cGMP bioprocessing manufacturing, cell therapy manufacturing or relevant experience.
- Bachelor's degree in relevant science or engineering discipline is preferred.
- GMP Compliance experience, knowledge of Data Integrity and ALCOA+ principles, and direct application of them.
- Experience in cell therapy manufacturing, including cell washing processes, cell separation processes, cryopreservation processes, cell expansion processes using incubators and bioreactors, and automated equipment.
- Experience with aseptic processing in ISO 5 biosafety cabinets, universal precautions for handling human derived materials in BSL-2 containment areas.
Qualifications
- Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing is preferred.
- Driven and motivated individual to learn and execute Cell Therapy Manufacturing operations.
- Able to work assigned shift (Day, Night, Weekends and/or Holidays).
- Comfortable working in a cleanroom environment and performing aseptic processing.
- Comfortable working with human blood components.
- Comfortable working in close proximity to strong magnets.
- Ability to travel to train and develop at other BMS Sites.
Skills and Abilities
- Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing is preferred.
- Driven and motivated individual to learn and execute Cell Therapy Manufacturing operations.
- Able to work assigned shift (Day, Night, Weekends and/or Holidays).
- Comfortable working in a cleanroom environment and performing aseptic processing.
- Comfortable working with human blood components.
- Comfortable working in close proximity to strong magnets.
- Ability to travel to train and develop at other BMS Sites.
Benefits
At Bristol Myers Squibb, 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.
Pay
The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience.
Schedule
Shifts Available: Sunday - Wednesday OR Wednesday - Saturday, 7am - 5pm.