Thursday, January 9, 2014

Job postings: Director of Chemistry, San Diego, CA

From the inbox, a position with Retrophin, a startup with a lab in San Diego, CA:

Department: CMC
Position/Title: Director of Chemistry, Validation and Tech Transfer

Responsibilities:
  • Coordinate analytical chemistry testing and evaluation of Retrophin’s drug substances, drug products and excipients, for identity, purity and strength 
  • Verify suitability, qualification and validation of analytical chemistry methods at Contract Manufacturing Organizations (CMO) and other external laboratories
  • Coordinate technology transfer of analytical methods to and from internal or external laboratories
  • Write technical reports on a wide variety of chemistry-related subjects
  • Maintains up-to-date knowledge of US and EU GMPs, USP, Ph.Eur, and ICH guidelines as applicable to analytical methods development and validation
  • Provide analytical support, trouble shooting, on internal and external project teams
  • Assist management during regulatory inspections and internal, and external audits
  • Assist with the development of CMC sections of regulatory submissions
  • Manage group of CMC experts
Requirements:
  • Ph.D. degree in Analytical Chemistry or closely related discipline
  • 10 years relevant experience (biotech, pharma, etc.)
  • Expert knowledge in analytical separation techniques, validation and technology transfer procedures
  • 2 years management experience
  • Excellent verbal and written communication skills
Interested? Contact Fazela Mohamed at  fazela -at- retrophin.com

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