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Associate Director, Drug Process Development & Manufacture in South San Francisco, CA



$100K - $150K*


Life Sciences


8 - 10 years

Job Description



The key focus of this role is oral-drug product process development and optimization, scale-up, tech transfer & validation, and clinical supplies manufacturing activities at CMOs to support on-going clinical trials as well as commercial for our small molecule portfolio.

Key Responsibilities include:

  • Oversee drug product manufacturing activities at CMOs to ensure cGMP compliance, drug products meeting all quality standards, and timely delivery of clinical supplies from Phase 1 through commercial launch.
  • Understand QbD concepts, apply effective DoE approaches to generate and execute process development/optimization plans, enable deep understanding of the manufacturing processes and possible impacts on drug product critical quality attributes.
  • Review, summarize and interpret process development data generated by CMOs, conduct statistical design and analysis, identify critical material attribu
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Valid through: 2020-5-19

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