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. 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 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.
- 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.
External Manufacturing & Supply
- 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.
Regulatory & Quality
- 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.
Who You Are
Required 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.
- 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.
Preferred Qualifications
- 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.
What Success Looks Like
- 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.
Location
This is a hybrid role, requiring 3 days per week onsite, in our NYC Headquarters.