Director, CMC Product Development – Small Molecule

About the role

The Director, CMC Product Development – Small Molecule leads end‑to‑end CMC development of small‑molecule drug product candidates, from early formulation through process development, clinical supplies and regulatory submission. This senior technical leader works cross‑functionally and with external CDMOs, without direct reports.

Key responsibilities

• Define and execute drug product development strategy, including formulation approach, manufacturing platform and roadmap.
• Lead formulation development across all clinical phases, covering excipient screening, compatibility studies, optimization and final composition selection.
• Oversee process development, scale‑up, technical transfer, validation and PPQ for solid oral dosage forms and other delivery systems.
• Serve as primary technical interface with CDMO partners, managing scope, scientific oversight, document review and deviation resolution.
• Author and review regulatory submission sections (IND, IMPD, NDA, MAA) and respond to FDA/EMA queries.
• Integrate Quality by Design (QbD) and Design of Experiments (DoE) to establish CQAs, CPPs and design spaces.
• Collaborate with Analytical Development on release specifications, stability and comparability strategies.
• Lead packaging development and container‑closure system selection, including child‑resistant requirements.

Required profile

• Ph.D. in Pharmaceutical Sciences, Pharmaceutics, Chemical Engineering or equivalent experience.
• 10+ years of small‑molecule drug product development and manufacturing experience.
• Proven track record as primary scientific lead from early to late clinical phases.
• Experience managing CDMO relationships, technical oversight and performance monitoring.
• Deep knowledge of ICH Q8/Q9/Q10/Q11, cGMP and regulatory expectations.
• Strong communication skills and ability to influence cross‑functional teams without direct authority.

Required skills

• Formulation development of solid oral dosage forms (immediate release, modified release, amorphous solid dispersions).
• Process development, scale‑up, technical transfer and validation for tablets and capsules.
• Quality by Design (QbD) and Design of Experiments (DoE) methodologies.
• Regulatory writing for IND, IMPD, NDA submissions.
• ICH guideline implementation (Q8/Q9/Q10/Q11) and cGMP compliance.