Scott Duncan

Experience

1. Process Development and Manufacturing Lead - Small Molecules

   Gates Medical Research Institute

   Jan 2023 — Present · Cambridge, MA, US

   Drug Substance Pharmaceutical Process Development & Manufacturing Leader for TBD09 & TBD10 programs. • Responsible for end-to-end CMC oversight of pharmaceutical development programs consisting of synthetic route selection, process development, scale-up, tech transfer, clinical manufacturing, and commercial scale development. • Oversee late-phase and commercial-facing route selection, process development, and analytical activities with a focus on access and affordability. May also manage and oversee corresponding early clinical phase activities. • Manage drug substance process transfers to the CMO network and subsequent manufacturing. • Develop and implement solutions for robust, scalable, safe, and cost-effective manufacture of drug substances to provide high-quality drugs to the Global Health sector. • Author CMC sections for regulatory filings. • Represent the CMC function on project teams and project sub-teams.

Education

• University of Wisconsin-Madison

  Doctor of Philosophy, Organic Chemistry

• Mercer University

  Bachelor of Science, Chemistry