Associate Director, Chemical Development/Drug Substance Manufacturing

139065
  • 175000 USD - 22000 USD
  • San Francisco, United States
  • Permanent
We are partnered with a late-stage biopharmaceutical company focused on developing small molecule drug candidates in the San Francisco area.

Responsibilities
  • Manage the development of chemical processes for manufacturing drug substances and mentor process chemists internally and at CMOs
  • Manage development activities for cGMP drug substance manufacturing of small molecule drugs at CMOs
  • Develop target drug substance profiles and specifications and maintain timelines for CMO manufacturing activities
  • Work cross functionally with CMC analytical team and formulations team, QA and Regulatory teams while representing the drug substance team in cross-functional working teams
  • Compile documentation and draft CMC sections for regulatory submissions
Qualifications
  • Ph.D. in Chemistry with strong synthetic organic chemistry knowledge
  • 8+ years of experience in small molecule drug substance development
  • Strong understanding of solid state properties of small molecules and solid problem solving skills
  • Direct experience with management of CMOs and managing direct reports
  • In depth understanding and knowledge of cGMP regulations and compliance
Reach out to learn more:
alanah@peoplewithchemistry.com
858-429-6147
Alanah Gaudreau Resourcer

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