Manufacturing Associate II, Cell Therapy in Devens, MA

Role Summary

Manufacturing Associate II, Cell Therapy within Manufacturing responsible for supporting routine manufacturing operations for Cell Therapy with emphasis on safety and quality, under good manufacturing practices.

Responsibilities

• Performing patient process unit operations and support operations described in standard operating procedures and batch records.
• Demonstrates strong practical and theoretical knowledge in their work.
• Completing documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records.
• Performing tasks in a manner consistent with the safety policies, quality systems, and GMP requirements.
• Completing training assignments to ensure the necessary technical skills and knowledge.
• Collaborates with support groups on recommendations and solving technical and operational problems.
• Identifies innovative solutions.
• Assisting in setting up manufacturing areas and equipment/fixtures; perform facility and equipment commissioning activities.
• Training others on SOPs, Work Instructions to successfully complete manufacturing operations.
• Executing 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 per controlled area classification and meet global Health Authority requirements.

Knowledge and Skills

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

Preferred Qualifications

• Aseptic processing in ISO 5 biosafety cabinets, universal precautions for handling human derived materials in BSL-2 containment areas.

Education / Basic Requirements

• High school diploma and 2+ years of experience in cGMP bioprocessing manufacturing, cell therapy manufacturing or relevant experience.
• Bachelor's in relevant science or engineering discipline and relevant experience is preferred.
• Experience in cell therapy manufacturing, including cell washing processes and automated equipment is preferred.
• Experience with cell separation techniques and automated equipment and Cryopreservation processes and equipment is a plus.

Additional Requirements

• PHYSICAL / MENTAL DEMANDS: Stand and walk for extended periods, lift up to 50 pounds, climb, bend, kneel, overhead work, repetitive use of limbs, PPE and cleanroom garments required.