Senior Manufacturing Associate, Cell Therapy in Devens, MA

Role Summary

Senior Manufacturing Associate, Cell Therapy in Devens, MA. Support routine manufacturing operations for Cell Therapy with a focus on safety, quality, and adherence to cGMP requirements. The role requires flexibility across shifts and a strong collaboration with production planning and other teams.

Responsibilities

• Execute operations described in standard operating procedures and batch records.
• Demonstrate 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 alignment with safety policies, quality systems, and GMP requirements.
• Complete training assignments to ensure necessary technical skills and knowledge.
• Train others on SOPs and Work Instructions to successfully complete manufacturing operations.
• Support investigations and 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 and compliant with cGMP.
• Work with production planning to execute daily unit operations schedule across multiple shifts.
• Work in a cleanroom environment and perform aseptic processing; maintain environmental conditions per area classifications.

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).
• Experience in cell therapy manufacturing, including cell washing, cell separation, automated equipment, and cryopreservation processes.
• Experience with aseptic processing in ISO 5 cabinets and handling human-derived materials in BSL-2 containment (preferred).
• Cell expansion using incubators and single-use bioreactors (preferred).
• High school diploma with 3+ years of experience in cGMP bioprocessing or cell therapy manufacturing; Bachelor’s degree strongly preferred.

Skills

• Proficiency with SOPs, batch records, and documentation in a GMP environment.
• Strong problem-solving, communication, and collaboration skills.
• Ability to operate in a cleanroom and perform aseptic processing.

Education

• High school diploma required; Bachelor’s degree in a relevant science or engineering field preferred.

Additional Requirements

• Standing/walking for extended periods; ability to lift up to 50 pounds; ability to climb and perform overhead work as needed.
• Willingness to wear PPE and cleanroom garments daily.