Clinical Manufacturing Associate II, Cell Therapy in Devens, MA

Clinical Manufacturing Associate II, Cell Therapy

The Clinical Manufacturing Associate II, Cell Therapy will be responsible for performing clinical patient process unit operations and supporting manufacturing activities described in standard operating procedures and batch records, maintaining cGMP compliance and ensuring quality throughout the process.

Sunday – Wednesday or Wednesday – Saturday, 7am – 5pm.

• Perform clinical patient process unit operations and support operations described in SOPs and batch records.
• Demonstrate strong practical and theoretical knowledge of work processes.
• Complete documentation required by process transfer protocols, validation protocols, SOPs, and batch records.
• Solve simple problems and identify innovative solutions using existing approaches.
• Carry out tasks in a manner consistent with safety policies, quality systems, and cGMP requirements.
• Complete training assignments to ensure necessary technical skills and knowledge.
• Reference batch records, SOPs, and work instructions to complete manufacturing operations.
• Execute daily unit operations schedule, coordinating people, product, and material flow across shifts.
• Operate in a cleanroom environment, performing aseptic processing and maintaining environmental conditions to meet regulatory requirements.
• Collaborate with support groups to recommend and solve technical and operational problems.
• Assist in setting up manufacturing areas, equipment, and fixtures; perform facility and equipment commissioning activities.
• Perform related tasks as required for a new startup facility.

• Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing.
• Driven and motivated to learn and execute Cell Therapy Manufacturing operations.
• Ability to work the assigned shift, including day, night, weekend and holiday shifts.
• Experience working in a cleanroom environment and performing aseptic processing.
• Comfortable working with human blood components.
• Ability to work in close proximity to strong magnets.
• Willingness to travel for training and development at other BMS sites (typically a week or less).

• 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 preferred.
• GMP compliance experience, knowledge of data integrity and ALCOA+ principles, and application of those principles.
• Experience in cell therapy manufacturing, including cell washing, separation, cryopreservation, expansion using incubators and bioreactors, and automated equipment.
• Experience with aseptic processing in ISO 5 biosafety cabinets and handling of human‑derived materials in BSL‑2 containment areas preferred.

• Stand and walk for several hours while operating equipment.
• Carry, lift, push, pull up to 50 pounds multiple times per day.
• Climb ladders and use stairwells throughout the day.
• Bend or kneel several times a day.
• Perform overhead reaching to handle materials up to 25 pounds.
• Move head and neck while using computer applications and handling equipment.
• Twist waist during equipment setup.
• Repetitive use of arms, wrists, and hands during setup and processing.
• Wear personal protective equipment and cleanroom garments daily.

Devens, MA – $29.83 to $36.15 per hour for full‑time employees. Additional incentive cash and stock opportunities may be available.

• Health coverage: medical, pharmacy, dental, and vision care.
• Wellbeing support programs, including BMS Well‑Being Account and Employee Assistance Programs.
• Financial well‑being and protection: 401(k) plan, disability, life insurance, supplemental health insurance, travel protection, personal liability protection, identity theft benefit, and legal support.