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Director, Analytical Development in South San Francisco, CA



$200K - $250K*


Physical Sciences, Life Sciences, Other Sciences


11 - 15 years

Job Description

Essential Job Functions:

  • This position will lead analytical development and quality control activities for Phase 1 to late stage drug development
  • Manage technology transfer and validation of analytical methods to support starting material, intermediate, drug substance and drug product testing at CMOs/CTOs
  • Establish and justify specifications for drug substances, starting materials, intermediates and drug products
  • Identify and characterize drug impurities and degradation products
  • Perform analytical method development for drug substances and drug products, including in-process control methods, and characterize physical and chemical properties of drug candidates
  • Oversee release testing and stability studies of drug substances and drug products at CMOs/CTOs, and trend stability and release data using statistical methods
  • Review and approval analytical results, protocols and reports
  • Support evaluation of packaging configur
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Valid through: 2020-4-8

About Principia Biopharma Inc.

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* Ladders Estimates

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