Sr Clinical Manufacturing Associate, Cell Therapy - Devens MA
About The Position
The Senior Clinical Manufacturing Associate supports clinical cell therapy manufacturing and start-up activities. The role calls for enthusiasm, intellectual curiosity, scientific rigor, flexibility, goal orientation, and the ability to work efficiently while prioritizing safety and quality. The associate applies a good understanding of good manufacturing practices to support and directly perform clinical manufacturing operations. The position involves working in a cleanroom and performing aseptic processing, maintaining environmental conditions in accordance with controlled-area specifications, and following batch records, standard operating procedures, work instructions, and applicable cGMP requirements. The associate also supports facility and equipment commissioning, manufacturing procedure development, production planning, and quality investigations. The role is based on-site in Devens, Massachusetts, and has a rotating 6 a.m.–6 p.m. schedule that includes weekends and holidays.
Requirements
- High school diploma.
- At least 3 years of experience in cGMP bioprocessing manufacturing, cell therapy manufacturing, or relevant experience.
- GMP compliance experience and knowledge of Data Integrity and ALCOA+ principles, with direct application of those principles.
- Ability to work the assigned shift, which may include day, night, weekends, and/or holidays.
- Ability to work in a cleanroom and perform aseptic processing.
- Comfort working with human blood components.
- Ability to work in close proximity to strong magnets.
- Ability to travel to other BMS sites for training and development; trips typically last a week or less.
- Ability to meet the described physical demands, including standing and walking for several hours, handling loads up to 50 pounds, climbing, bending or kneeling, overhead reaching, 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.
- Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing.
- Experience in cell therapy manufacturing, including cell washing, cell separation, cryopreservation, cell expansion using incubators and bioreactors, and automated equipment.
- Experience with aseptic processing in ISO 5 biosafety cabinets and universal precautions for handling human-derived materials in BSL-2 containment areas.
Responsibilities
- Perform clinical patient-process unit operations and other operations specified in standard operating procedures and batch records.
- Apply practical and theoretical knowledge to manufacturing work.
- Complete documentation required by process-transfer and validation protocols, standard operating procedures, and batch records.
- Solve routine problems using existing solutions and identify innovative solutions.
- Perform tasks consistently with safety policies, quality systems, and cGMP requirements.
- Complete training assignments to develop required technical skills and knowledge.
- Work in a cleanroom and perform aseptic processing.
- Maintain manufacturing environmental conditions, including particulate and viable microbial levels, through required area disinfection.
- Reference batch records, standard operating procedures, and work instructions to complete manufacturing operations.
- Assist with setting up manufacturing areas, equipment, and fixtures, and perform facility and equipment commissioning activities.
- Support development of technically sound and efficient manufacturing operating procedures that comply with cGMP requirements.
- Support production planning for daily unit-operation schedules, including people, product, and material flow across multiple shifts.
- Support quality-event investigations.
- Perform related tasks as needed to contribute to a new start-up facility.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
High school or GED
