Mfg Cell Processing Specialist 3

ProKidney

Winston, United States
On-site
Cgmp compliance expertise
Cell processing activities
Control rate freezer operation
ProKidney is seeking a Mfg Cell Processing Specialist 3 for their Winston location, responsible for advanced cell processing activities while ensuring compliance with cGMP guidelines. The role involves operating production equipment, mentoring team members, and driving continuous improvement in manufacturing processes

Job Summary

  • The Mfg Cell Processing Specialist 3 plays a critical role in supporting advanced manufacturing operations with a focus on cell processing activities and ensuring compliance with cGMP guidelines.
  • This position involves leading investigations into deviations, mentoring team members, and driving continuous improvement to maintain high levels of quality and safety.
  • Candidates must possess strong computer skills including ERP systems and the ability to exercise independent judgment while adhering to strict sterile techniques in a cleanroom environment.

Matching Summary

Match Score: 85

ProKidney is seeking a Mfg Cell Processing Specialist 3 for their Winston location, responsible for advanced cell processing activities while ensuring compliance with cGMP guidelines. The role involves operating production equipment, mentoring team members, and driving continuous improvement in manufacturing processes.

Skills & Requirements

Must-have

  • cGMP compliance expertise
  • cell processing activities
  • control rate freezer operation
  • aseptic cleanroom techniques
  • SOP implementation and revision
  • deviation investigation leadership

Nice-to-have

  • mentorship of junior team members
  • continuous improvement initiatives
  • strong problem-solving skills
  • ERP system transaction execution
  • process development support

Key Requirements

  • 4-6 years relevant experience in cell processing
  • 2-3 years proven cGMP regulated environment experience
  • AS/BS in Biotechnology, Biology, or Chemistry
  • Eligible to work in US without visa sponsorship

Work Rights

Must be eligible to work in US without visa sponsorship

Tailored Resume

Cover Letter