Associate Director, MSAT Operations

4 weeks ago


San Diego, California, United States Tanvex BioPharma Inc Full time
Job Summary

The Associate Director, MSAT is responsible for leading and enabling MSAT as a strategic champion, manager, and Subject Matter Expert (SME) for mammalian and microbial drug substance manufacturing of biologics for clinical and commercial use in our contract development and manufacturing (CDMO) and in-house programs.

Key Responsibilities
  • Apply advanced engineering principles to transfer, monitor, validate, and troubleshoot drug substance manufacturing processes.
  • Partner with cross-functional teams to drive implementation of new technologies, improve manufacturing efficiency, and ease of operations.
  • Manage and develop the MSAT team through individual goal setting, performance reviews, and coaching.
  • Lead manufacturing and process-related deviation investigations, assess impact to product quality, and propose corrective and preventative actions.
  • Implement new equipment and process technologies, train manufacturing personnel, and serve as a technical resource on equipment capabilities and troubleshooting.
Requirements
  • Bachelor's or advanced degree in chemical/biochemical engineering, chemistry/biochemistry, biological sciences, or related disciplines.
  • 15 years of relevant experience, or MS with 10 years of relevant experience, or PhD with 5 years of relevant experience in biopharmaceutical research and manufacturing settings.
  • 5 years of management experience required.
  • Advanced experience with biopharmaceutical manufacturing process and equipment.
  • Proven track record of leading MSAT functions and implementing MSAT strategies.
  • Extensive knowledge of cGMP regulations/guidance and quality systems.
Work Environment

This role requires spending up to 80% of time working in a standard office environment, with regular use of standard office equipment and occasional work in a biosafety level 1 laboratory environment.



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