Clinical Manufacturing Associate II, Cell Therapy in Devens, MA

Clinical Manufacturing Associate II, Cell Therapy

The Clinical Manufacturing Associate II supports Clinical Cell Therapy manufacturing operations, including startup activities, unit operations, and quality documentation. The role requires adherence to cGMP, safety, and quality standards and contributes to the launch of novel cell therapy programs.

• Sunday
  - Wednesday or Wednesday
  - Saturday, 7am - 5pm

• Perform unit operations per SOPs and batch records.
• Demonstrate strong practical and theoretical knowledge of processes.
• Complete documentation required by process transfer, validation, and SOPs.
• Solve simple problems and propose innovative solutions.
• Adhere to safety policies, quality systems, and cGMP requirements.
• Complete training assignments to acquire technical skills.
• Use batch records, SOPs, and work instructions for manufacturing operations.
• Execute daily unit operations schedule covering people, product, and material flow.
• Work in a cleanroom environment and perform aseptic processing while maintaining environmental conditions per global Health Authority specifications.
• Collaborate with support groups to recommend and resolve technical and operational issues.
• Assist in setting up manufacturing areas, equipment, and fixtures, including commissioning activities.
• Perform related tasks to support a new startup facility as required.

• Knowledge of cGMP regulations and FDA guidance for biologics and cell therapy manufacturing.
• Motivated to learn and execute cell therapy manufacturing operations.
• Ability to work assigned shifts (day, night, weekends, holidays).
• Experience working in a cleanroom and performing aseptic processing.
• Comfortable handling human blood components and working near strong magnets.
• Willingness to travel for training and development at other BMS sites (typically a week or less).
• Minimum Requirements: High school diploma with 2+ years of cGMP bioprocessing or cell therapy manufacturing experience;
  Bachelor's in relevant science or engineering preferred; GMP compliance experience;
  Data Integrity and ALCOA+ principles application; experience with cell washing, separation, cryopreservation, expansion, or automated equipment; aseptic processing in ISO 5 biosafety cabinets and BSL-2 containment preferred.

• Stand and walk while operating manufacturing/computer equipment for several hours daily.
• Carry, lift, push, pull up to 50 pounds multiple times a day.
• Climb ladders or use stairwells repeatedly.
• Bend or kneel multiple times a day.
• Perform overhead reaching for materials up to 25 pounds.
• Move head and neck while using computers and handling equipment.
• Twist waist during equipment setup.
• Frequent repetitive use of arms, wrists, and hands.
• Wear PPE and cleanroom garments daily.

Devens, MA – $29.83–$36.15 per hour for full‑time employees. Additional incentive cash and stock opportunities may be available. Final compensation is based on demonstrated experience.

BMS is an equal opportunity employer that embraces diversity, acknowledges differing perspectives, and promotes inclusive hiring practices. BMS considers qualified applicants with arrest and conviction records in accordance with applicable laws. For more information on EEO and accessibility, please visit the BMS careers site.