Manufacturing Associate, Cell Therapy in Devens, MA

Overview

The Manufacturing Associate, Cell Therapy supports routine manufacturing operations for Cell Therapy with a focus on safety, quality, and good manufacturing practices. The role involves working in a cleanroom environment, following GMP requirements, and contributing to process transfer and production efficiency. Shifts available:
Days (6am – 6pm) and Nights (6pm – 6am), onsite with rotating holidays and weekends.

• Perform patient process unit operations and support operations described in standard operating procedures and batch records.
• Complete documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records.
• Work in a manner consistent with safety policies, quality systems, and GMP requirements.
• Complete training assignments to acquire the necessary technical skills and knowledge.
• Assist in setting up manufacturing areas and equipment/fixtures; perform facility and equipment commissioning activities.
• Reference Batch Records, SOPs, and Work Instructions to successfully complete manufacturing operations.
• Execute the daily unit operations schedule that includes people, product, and material flow across multiple shifts.
• Work in a cleanroom environment and perform aseptic processing; maintain environmental conditions per controlled area classification specifications.

• Driven and motivated to learn and execute Cell Therapy Manufacturing operations.
• Ability to work assigned shift (Day, Night, Weekends and/or Holidays).
• Experience in a cleanroom environment and aseptic processing.
• Comfort with exposure to human blood components.
• Ability to be in close proximity to strong magnets.
• Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing preferred.

• High school diploma and 0-2 years of experience in cGMP bioprocessing manufacturing, cell therapy manufacturing, or relevant experience.
• Bachelor's degree in a relevant science or engineering discipline preferred.

PHYSICAL / MENTAL DEMANDS:

• Stand and walk for several hours at a time while operating manufacturing/computer equipment.
• Lift up to 50 pounds several times a day; carry, push, and pull as required.
• Climb stairs or ladders as needed; bend, kneel, and perform overhead work regularly.
• Move head/neck while using computer applications and handling materials; repetitive arm/wrist/hand use.
• Wearing PPE and clean room garments daily (safety shoes, glasses, aprons, face shields, lab coats, gowns, hairnets, gloves, hearing protection).

Compensation overview:
Devens, MA, US – $25.34 to $30.70 per hour. Eligible for additional incentive cash and stock opportunities based on eligibility. Final compensation based on experience. Benefits include health coverage (medical, pharmacy, dental, vision), wellbeing programs, 401(k) with disability and life insurance, and other protections. Some time-off options and travel considerations are provided; details vary by location and eligibility.

On-site protocol and occupancy: site-essential, site-by-design, field-based, and remote-by-design roles with onsite requirements varying by role. Equal Employment Opportunity statements and data protection notices are provided as part of the posting. For accessibility and inquiries, please refer to the company careers site and contact information listed in the posting.