Manufacturing Associate, Cell Therapy in Devens, MA
$52,707–$63,856 year
On-siteDevens, Massachusetts, United States
Job Summary
Perform patient process unit operations and support operations per standard operating procedures and batch records. Complete documentation for process transfer, validation, and batch records. Execute daily unit operations schedules managing people, product, and material flow across shifts in a cleanroom environment. Assist with setting up manufacturing areas and equipment, including commissioning activities. Maintain aseptic processing standards and disinfect areas to meet global health authority requirements. Refer to batch records and work instructions to ensure safety policies and GMP compliance. Complete training assignments to acquire necessary technical skills.
Required Qualifications
- High school diploma
- 0-2 years of experience in cGMP bioprocessing manufacturing, cell therapy manufacturing or relevant experience
- 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
Desired Qualifications
- Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing
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