Specialist, Lead Clinical Manufacturing Associate, Cell Therapy

Job Summary

A Specialist, Lead Clinical Manufacturing Associate, Cell Therapy will support and execute clinical manufacturing operations for cell therapy programs, ensuring compliance with cGMP regulations and company quality systems. The role involves aseptic processing, equipment and area commissioning, production scheduling, and cross‑functional collaboration to meet launch and ongoing manufacturing goals.

• Perform clinical patient process unit operations according to standard operating procedures and batch records.
• Complete documentation required by process transfer protocols, validation protocols, and batch records.
• Operate in a cleanroom environment and conduct aseptic processing while maintaining environmental conditions in accordance with controlled area specifications.
• Execute area disinfection procedures to meet global health authority requirements.
• Reference batch records, SOPs, and work instructions to complete manufacturing operations.
• Solve complex problems and propose innovative solutions to manufacturing challenges.
• Set up and commission manufacturing areas, equipment, and fixtures.
• Collaborate closely with Manufacturing Managers to ensure seamless transition of activities.
• Coordinate with production planning to execute daily unit operation schedules, managing people, product, and material flow across shifts.
• Facilitate team‑based, cross‑functional collaboration to meet shift production targets.
• Collaborate with support groups to recommend and resolve technical and operational issues.
• Assist in the development of manufacturing operating procedures that are technically sound, efficient, and compliant with cGMP.
• Support quality event investigations as required.
• Contribute to startup activities for new manufacturing facilities.

• At least 4+ years of experience in cGMP bioprocessing or cell therapy manufacturing.
• Bachelor’s degree in a relevant science or engineering discipline, or equivalent work experience.
• Experience with GMP compliance, data integrity (ALCOA+ principles), and direct application of these principles.
• Hands‑on experience in cell washing, cell separation, cryopreservation, and cell expansion processes using incubators and bioreactors.
• Proficiency in aseptic processing within ISO 5 biosafety cabinets and handling human‑derived materials in BSL‑2 containment.
• Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing.
• Ability to work assigned shifts (day, night, weekends, and/or holidays) and travel for training to other BMS sites.
• Comfortable working in a cleanroom environment and near strong magnets.

• Stand and walk for extended periods while operating equipment.
• Carry, lift, push, and pull up to 50 lbs multiple times a day.
• Climb ladders or stairwells as needed in production areas.
• Bend, kneel, and perform overhead reaching tasks with materials up to 25 lbs.
• Move head and neck while using computer applications and handling equipment.
• Twist waist during equipment setup.
• Repetitive use of arms, wrists, and hands throughout the shift.
• Wear personal protective equipment and cleanroom garments as required.

Shifts:

Wednesday – Saturday, 7am – 5pm. Compensation: $40.05 – $48.53 per hour (Devsinc, MA, US). Additional incentive cash and stock opportunities may be available, based on eligibility.

The role includes health coverage (medical, pharmacy, dental, vision), wellness programs, a 401(k) plan, life and disability insurance, paid time off, and a global shutdown period. For full details, visit the company careers site.

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