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
- 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
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looks like Blogger doesn't work with anonymous comments from Chrome browsers at the moment - works in Microsoft Edge, or from Chrome with a Blogger account - sorry! CJ 3/21/20