Vice President, Product Development - CMC, Small Molecules

Role Summary

Vice President, Product Development – CMC, Small Molecules. Lead all CMC activities for the company’s small molecule pipeline, overseeing drug substance and drug product development, analytical development, and combination product development. Ensure programs meet scientific, quality, regulatory, and commercial standards, while coordinating internal teams and external partners.

Responsibilities

• Define and execute the CMC strategy for all small molecule programs across their lifecycle, from preclinical development through commercialization.
• Lead drug substance (API) and drug product development, including formulation development, process chemistry, and scale-up operations.
• Oversee analytical method development and validations; manage experience with combination devices.
• Ensure manufacturing readiness for clinical and commercial supply chains.
• Support global CMC regulatory strategies aligned with clinical and commercial objectives; author, review, and approve CMC sections of regulatory submissions (INDs, NDAs/MAAs, etc.); ensure compliance with ICH, FDA, EMA, PMDA, and other guidelines.
• Build and lead a high-performing CMC team; manage relationships with external manufacturing partners and CDMOs.
• Collaborate cross-functionally with Discovery, Clinical Development, Quality, Regulatory Affairs, Operations, and Commercial teams; provide technical due diligence support for business development.
• Provide strategic leadership and contribute to overall product development strategy as a Technical Operations leadership team member.

Qualifications

• Ph.D. or advanced degree in Chemistry, Pharmaceutical Sciences, Chemical Engineering, or related field.
• 15+ years of progressive CMC development experience for small molecule pharmaceuticals, with at least 7 years in senior leadership.
• Proven track record in advancing programs from preclinical to commercial launch.
• Deep knowledge of small molecule process chemistry, formulation, and analytical development.
• Demonstrated success in regulatory submissions and global CMC regulatory requirements.
• Experience managing external partners (CMOs/CDMOs).
• Strong leadership, strategic thinking, and communication skills.

Skills

• Strategic leadership in CMC
• Regulatory affairs for CMC (INDs, NDAs/MAAs)
• Process chemistry, formulation development, analytics
• Team building and external partnerships management
• Cross-functional collaboration and due diligence

Education

• Ph.D. or advanced degree in a relevant field (Chemistry, Pharmaceutical Sciences, Chemical Engineering, or related).

Additional Requirements

• Travel: Occasional global travel (approximately 30%).
• Location: Remote work possible; some in-person collaboration as needed; option for remote work with occasional in-person meetings if within driving distance of Bridgewater, NJ.