Senior Manufacturing Associate, Cell Therapy in Devens, MA

Role Summary

Bristol Myers Squibb’s Cell Therapy Manufacturing team is seeking a Senior Manufacturing Associate, Cell Therapy in Devens, MA. The role supports routine manufacturing operations for cell therapy with emphasis on safety, quality, and cGMP compliance. The successful candidate will execute SOPs and batch records, contribute to process documentation, assist with equipment setup and commissioning, train others, and collaborate with production planning across multiple shifts.

Responsibilities

• Execute operations described in standard operating procedures and batch records.
• Demonstrates strong practical and theoretical knowledge in their work.
• Complete documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records.
• Solve simple problems; apply new perspectives using existing solutions.
• Perform tasks in a manner consistent with the safety policies, quality systems, and GMP requirements.
• Complete training assignments to ensure the necessary technical skills and knowledge.
• Train others on SOPs and Work Instructions to successfully complete manufacturing operations.
• Support investigations.
• Identify innovative solutions.
• Assist in setting up manufacturing areas and equipment/fixtures; perform facility and equipment commissioning activities.
• Write manufacturing operating procedures that are technically sound, promote effective and efficient operations, and comply with cGMP requirements.
• Work with production planning to execute daily unit operations schedule that includes people, product, and material flow across multiple shifts.
• Work in a cleanroom environment and perform aseptic processing; maintain manufacturing environmental conditions (Non-Viable Particulate(s) and Viable microbial levels per controlled area classification specifications) by performing area disinfection regiment as required to meet global Health Authority requirements.

Qualifications

• Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing.
• Ability to work assigned shift (Day, Night, Weekends and/or Holidays).
• Ability to work in a cleanroom environment and perform aseptic processing.
• Comfortable being exposed to human blood components.
• Ability to be in close proximity to strong magnets.
• Experience in cell therapy manufacturing, including cell washing processes and automated equipment; cell separation techniques and automated equipment; cryopreservation processes and equipment.
• Preferred: Aseptic processing in ISO 5 biosafety cabinets, universal precautions for handling human-derived materials in BSL-2 containment areas.
• Cell expansion using incubators and single-use bioreactors.

Education

• High school diploma and 3+ years of experience in cGMP bioprocessing manufacturing, cell therapy manufacturing or relevant experience.
• Bachelor's in relevant science or engineering discipline and relevant experience strongly preferred.

Additional Requirements

• Stand and Walk - Required to stand/walk while operating manufacturing/computer equipment for several hours at a time, throughout the day.
• Carrying weight, Pushing, Pulling Lifting - Required to carry, lift, push, and/or pull up to 50 pounds several times a day while handling production equipment and/or materials.
• Climb - Required to climb (use of stepladders in production areas, or stairwells) several times a day.
• Bend and Kneel - Required to bend or kneel several times a day.
• Overhead work - Required to perform overhead reaching during handling of production materials/files/supplies up to 25 pounds several times a day, throughout the day.
• Moving Head and Neck - Required movement of head/neck while using computer applications and handling of production equipment and materials several times a day, throughout the day.
• Twisting - Required movement of twisting waist while setting up equipment several times a day, throughout the day.
• Repetitive Use - Required repetitive use of arms/wrists/hands while setting up equipment and processing several times a day, throughout the day.
• Will be required to wear personal protective equipment (PPE) and other clean room garments daily. This may include, but not limited to; safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hairnets, gloves, and hearing protection.