Manufacturing Team Leader

1 week ago


Santa Monica, California, United States Neogene Therapeutics Full time
Job Summary

We are seeking an experienced Manufacturing Team Leader to join our team at Neogene Therapeutics. As a key member of our manufacturing operations, you will be responsible for ensuring the successful manufacture and release of cell therapy products in compliance with cGMP regulations.

Key Responsibilities
  • Lead the manufacturing operational readiness and successful tech transfer using knowledge of cGMP regulations.
  • Develop and implement Standard Operating Procedures (SOPs) for manufacturing processes.
  • Ensure all materials and equipment are identified and available in time for manufacturing activities.
  • Support Process Development to align manufacturing plans with product development plans.
  • Ensure that all production operations are controlled and performed within cGMP regulatory guidelines.
Requirements
  • 8+ years of experience in cGMP or cell therapy manufacturing.
  • Experience with cGMP process and knowledge of CMC regulatory framework for biologics.
  • Experience of aseptic techniques for primary human cell cultures and GMP manufacturing.
  • Direct experience supporting tech transfer and GMP clinical/commercial manufacturing operations.
What We Offer

We offer a competitive salary range of $105,000 to $124,000, depending on experience. We are an equal opportunity employer and celebrate diversity and inclusion in the workplace.



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