Sr Manufacturing Associate, Cell Therapy - Devens MA
About The Position
Bristol Myers Squibb is seeking a Senior Manufacturing Associate, Cell Therapy to support routine cell therapy manufacturing operations. The role calls for enthusiasm, intellectual curiosity, scientific rigor, flexibility, and a goal-oriented approach, with safety, quality, and good manufacturing practices guiding the work. The associate executes manufacturing operations, supports process and facility activities, contributes to investigations and improvements, and helps train other personnel. The position is onsite in Devens, Massachusetts, with a 6 a.m.–6 p.m. rotating shift that includes holidays and weekends. Work takes place in a cleanroom and involves aseptic processing, maintaining controlled environmental conditions, and handling human blood components. The role also includes substantial 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 working in close proximity to strong magnets and being exposed to human blood components.
- Experience in cell therapy manufacturing, including cell washing and cell separation processes and automated equipment, and cryopreservation processes and equipment.
- Ability to meet the physical demands described, including standing and walking for several hours, carrying/lifting/pushing/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.
- Aseptic processing experience in ISO 5 biosafety cabinets.
- Experience with 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 build necessary technical skills and knowledge.
- Train others on SOPs and work instructions so they can successfully complete 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, including 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, through required area disinfection.
- Perform cell therapy manufacturing activities involving cell washing, cell separation, and cryopreservation processes and automated equipment.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
High school or GED
