Hiring: Director, CMC – Small Molecule Chemistry Company: Pathos Location: New York, NY Job Posted Time: 2026-09-03 14:41:45 Employment Type: Hybrid Target Skills & Keywords : ACLS About the job Experience: •10+ years of pharmaceutical/biotech CMC experience with demonstrated depth in synthetic, organic, or medicinal chemistry. Required Skills: •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 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. •Process & Analytical Development •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. Qualifications: •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. •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. •Operational familiarity with high-potency (HPAPI/OEB) handling and containment relevant to oncology compounds. •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. Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!