Director, CMC – Small Molecule Chemistry

Drug development shouldn’t be guesswork, not when patients are waiting.

• 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.
• Guide analytical method development, qualification/validation, specifications setting, impurity and genotoxic impurity control strategies, and stability programs.
• Apply QbD and risk-based principles to build robust control strategies and process understanding.

• Select, manage, and technically oversee CDMOs/CMOs for API and drug product manufacture, tech transfer, and scale-up.
• Ensure timely, phase-appropriate clinical supply (Phase 1–3) and lead process performance and validation activities to support late-stage development and eventual commercialization.
• Author and review batch records, development reports, and technical transfer packages; troubleshoot process and analytical issues.

• Author and review CMC sections of regulatory filings (IND, IMPD, briefing documents, and later NDA/MAA modules) and support health-authority interactions.
• Partner with Quality to ensure GMP compliance, manage deviations and change control, and support internal and external audits.

• Ph.D. in Synthetic Organic Chemistry, Medicinal Chemistry, or a closely related field (or an M.S./B.S. with commensurate additional experience).
•  8–10+ years of pharmaceutical/biotech CMC experience with demonstrated depth in synthetic, organic, or medicinal chemistry.
• Direct experience in oncology drug development.
• Proven track record across the full development lifecycle: phase-appropriate development for Phase 1–3 as well as hands-on experience with late-stage development.
• Experience in BOTH a small/emerging biotech and a large pharma environment, with the versatility to operate effectively in each.
• Deep, hands-on knowledge of API route design and process development, drug product formulation, analytical development, impurity control, and stability.
• Demonstrated success managing CDMOs/CMOs and leading technical transfer and scale-up.
• Strong command of ICH, FDA, and EMA CMC guidance and phase-appropriate GMP expectations, with experience authoring CMC regulatory submissions.

• Experience taking a small-molecule oncology asset through pivotal/late-stage development and toward registration.
• Familiarity with high-potency (HPAPI/OEB) handling and containment relevant to oncology compounds.
• Experience with continuous manufacturing, complex/novel formulations, or drug–device combinations.
• Comfort operating in a data- and technology-forward organization; interest in leveraging AI/ML to accelerate CMC decision-making.

• Reliable, phase-appropriate clinical supply that never gates the clinical program.
• Robust, well-understood processes and control strategies that de-risk the path to late-stage development.
• Clean, defensible CMC regulatory submissions and successful health-authority interactions.

This is a hybrid role, requiring 3 days per week onsite, in our NYC Headquarters.