NIGHT SHIFT: Senior Manufacturing Associate, Cell Therapy in Devens, MA

Role Summary

Senior Manufacturing Associate, Cell Therapy – Devens, MA. Performs routine manufacturing operations for cell therapy products under cGMP, including aseptic processing in a cleanroom, documentation, and equipment setup. Collaborates with production planning and cross-functional teams, supports investigations, and trains others while maintaining safety and quality. Shift: 6pm–6am, rotating with holidays and weekends, onsite.

Responsibilities

• Execute operations described in standard operating procedures and batch records.
• Demonstrate strong practical and theoretical knowledge in their work.
• Complete documentation required by process transfer protocols, validation protocols, SOPs, and batch records.
• Solve simple problems; apply existing solutions from new perspectives.
• Perform tasks in a manner consistent 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.
• 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 per controlled area classification specifications and conduct area disinfection as required to meet global Health Authority requirements.

Qualifications

• Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing. Required
• Ability to work assigned shift (Day, Night, Weekends and/or Holidays). Required
• Ability to work in a cleanroom environment and perform aseptic processing. Required
• Comfortable being exposed to human blood components. Required
• Ability to be in close proximity to strong magnets. Required
• Experience in cell therapy manufacturing, including cell washing processes and automated equipment; cell separation techniques and automated equipment; cryopreservation processes and equipment. Required
• Experience in aseptic processing in ISO 5 biosafety cabinets, universal precautions for handling human derived materials in BSL-2 containment areas. Preferred
• Cell expansion using incubators and single-use bioreactors. Preferred
• High school diploma and 3+ years of experience in cGMP bioprocessing manufacturing, cell therapy manufacturing or relevant experience. Required
• Bachelor's in relevant science or engineering discipline and relevant experience strongly preferred. Preferred

Skills

• Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing.
• Must have the ability 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.
• Experience in cell therapy manufacturing, including cell washing processes and automated equipment; cell separation techniques and automated equipment. Cryopreservation processes and equipment.
• Experience in 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 for several hours at a time.
• Carry, lift, push, and/or pull up to 50 pounds several times a day.
• Climb (stepladders or stairs) several times a day.
• Bend and kneel several times a day.
• Overhead work requiring reaching up to 25 pounds several times a day.
• Repetitive use of arms/wrists/hands while handling equipment and materials.
• Wear personal protective equipment (PPE) and clean room garments daily (e.g., safety shoes, safety glasses, aprons, face shields, lab coats, gowns, hairnets, gloves, hearing protection).