Remote Regulatory CMC Director

Location: Nationwide

Compensation: To Be Discussed

Staff Reviewed: Wed, Mar 31, 2021

This job expires in: 13 days

Job Category: Healthcare

Remote Level: 100% Remote

Weekly Hours: Full Time

Employer Type: Employer

Career Level: Experienced

Education Level: Doctorate

Job Summary

A company dedicated to the development of gene therapies is seeking a Remote Regulatory CMC Director.

Must be able to:

  • Provide Regulatory CMC leadership
  • Participate in definition and implementation of Chemistry, Manufacturing and Controls (CMC)
  • Regularly assess and communicate regulatory risks associated with assigned program

Qualifications Include:

  • M.S. or PhD in chemistry, cell biology, pharmacology, pharmacy, bio/chemical engineering or
  • Closely related field
  • (8 -10 years) regulatory CMC experience with biologics and/or ATMPs
  • Experience with life cycle management of biologics or ATMPs required
  • Understanding of manufacturing, testing and regulation of of biotechnology and/or gene therapy products
  • Experience in leading Module 3 sections for investigational and marketing applications for biotech/ATMP

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