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Director, CMC – Small Molecule Chemistry

Pathos · New York, NY · On-site

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About Pathos

Drug development shouldn’t be guesswork, not when patients are waiting. Pathos is building a next-generation biotech with AI at the core. Not as a feature, but as the operating system for how medicines get developed. Backed by NEA.

About the role

We are seeking a Director, CMC – Small Molecule Chemistry to lead the chemistry, manufacturing, and controls strategy for our small-molecule oncology programs. This individual will own drug substance and drug product development — from early clinical supply through late-stage development — ensuring phase-appropriate quality, robust processes, and regulatory-ready documentation. This is a foundational hire on the Pathos CMC/Technical Operations team.

What they're looking for

  • Expert in Synthetic, Organic or Medicinal Chemistry of Oncology Compounds and comfortable building phase-appropriate end-to-end CMC strategy
  • Define and execute the end-to-end small-molecule CMC strategy for one or more oncology programs, spanning drug substance (API) and drug product
  • Serve as the CMC program lead and single point of accountability, representing CMC on cross-functional program teams alongside Research, Clinical, Regulatory, and Quality
  • Translate program goals and timelines into phase-appropriate development plans, budgets, and risk-mitigation strategies
  • Direct route scouting, synthetic route selection, and process development for APIs, applying deep synthetic and organic chemistry expertise to deliver scalable, cost-effective, and controllable processes
  • Oversee drug product formulation and process development, including solid oral and other dosage forms appropriate to oncology indications
More about this role

We are seeking a Director, CMC – Small Molecule Chemistry to lead the chemistry, manufacturing, and controls strategy for our small-molecule oncology programs. This individual will own drug substance and drug product development — from early clinical supply through late-stage development — ensuring phase-appropriate quality, robust processes, and regulatory-ready documentation. This is a foundational hire on the Pathos CMC/Technical Operations team. You will help build and scale the chemistry, manufacturing, and controls function from an early stage, partnering with the Head of CMC and working with Research, Clinical, Regulatory, and Quality colleagues in a fast-moving, resource-conscious environment. You are equally comfortable rolling up your sleeves on technical detail and operating strategically across a portfolio.

What You Will Do

CMC Strategy & Program Leadership

  • Expert in Synthetic, Organic or Medicinal Chemistry of Oncology Compounds and comfortable building phase-appropriate end-to-end CMC strategy
  • Define and execute the end-to-end small-molecule CMC strategy for one or more oncology programs, spanning drug substance (API) and drug product.
  • Serve as the CMC program...

Read the full posting on Pathos's site ↗

Clinical

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