Senior Manufacturing Associate, Cell Therapy in Devens, MA
About The Position
Bristol Myers Squibb is seeking a goal-oriented, flexible Senior Manufacturing Associate to support routine cell therapy manufacturing operations. The role requires enthusiasm, intellectual curiosity, scientific rigor, and a strong commitment to safety, quality, and good manufacturing practices. The associate executes manufacturing activities and supports novel programs while working efficiently across multiple shifts. The position is onsite in Devens, Massachusetts, with a rotating 6 a.m.–6 p.m. shift that includes weekends and holidays. Work is performed in a cleanroom and includes aseptic processing, environmental control, and handling human blood components. The role also involves physical activity and daily use of personal protective equipment and cleanroom garments.
Requirements
- High school diploma and at least 3 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.
- Ability to work the assigned shift, including days, nights, weekends, and/or holidays.
- Ability to work in a cleanroom environment and perform aseptic processing.
- Comfort with exposure to human blood components.
- Ability to work in close proximity to strong magnets.
- Ability to meet the role’s physical demands, including standing and walking for several hours; carrying, lifting, pushing, or pulling up to 50 pounds; climbing; bending or kneeling; overhead reaching with items up to 25 pounds; and repetitive movements.
- Ability to wear personal protective equipment and cleanroom garments daily.
Nice To Haves
- Bachelor’s degree in a relevant science or engineering discipline and relevant experience.
- Experience in cell therapy manufacturing, including cell washing processes and automated equipment, cell separation techniques and automated equipment, and cryopreservation processes and equipment.
- Aseptic processing experience in ISO 5 biosafety cabinets.
- Knowledge of universal precautions for handling human-derived materials in BSL-2 containment areas.
- Cell expansion experience using incubators and single-use bioreactors.
Responsibilities
- Execute operations described in standard operating procedures and batch records.
- Complete documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records.
- Perform tasks in accordance with safety policies, quality systems, and GMP requirements.
- Complete training assignments to develop and maintain the necessary technical skills and knowledge.
- Train others on SOPs and work instructions for manufacturing operations.
- Support investigations and identify innovative solutions.
- Assist with setting up manufacturing areas, equipment, and fixtures, and perform facility and equipment commissioning activities.
- Write technically sound manufacturing operating procedures that promote effective and efficient operations and comply with cGMP requirements.
- Work with production planning to execute the daily unit operations schedule, coordinating people, product, and material flow across multiple shifts.
- Work in a cleanroom and perform aseptic processing.
- Maintain manufacturing environmental conditions, including non-viable particulate and viable microbial levels, by performing area disinfection as required.
Benefits
- Comprehensive benefit plans, including wellbeing support, retirement and financial protection benefits, and medical, dental, vision, life, and disability insurance offerings.
- For non-exempt employees: 160 hours of paid vacation annually for new hires, subject to manager approval; 11 paid company holidays; and 3 optional holidays.
- Depending on eligibility, paid sick leave, up to two paid volunteer days per year, summer-hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs.
- Eligible employees may receive an annual Global Shutdown between Christmas Day and New Year’s Day.
- Potential eligibility for discretionary incentive cash and stock opportunities.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
High school or GED
