Description

You will provide technical leadership for late-stage drug substance development, technology transfer to CDMOs, and commercial readiness. You'll oversee process validation, manufacturing campaigns, and CMC regulatory submissions to ensure robust, compliant processes for NDA filing and commercial launch.

Requirements

• Ph.D. in Organic Chemistry with ~10+ years experience (or M.S. with ~15+ years) in small molecule CMC drug substance development
• Experience leading technology transfer, scale-up, and validation of API processes to GMP sites
• Strong experience managing CDMOs with technical oversight of manufacturing campaigns
• Proven success authoring CMC sections of IND/NDA submissions and supporting regulatory responses
• Deep understanding of cGMP requirements and global regulatory expectations

Responsibilities

• Lead technology transfer of drug substance processes to CDMOs
• Provide technical oversight of CDMO activities and serve as primary technical contact
• Review and approve manufacturing documentation including batch records and deviations
• Drive process robustness, control strategy development, and PPQ readiness
• Author and review CMC sections of IND/NDA submissions and support regulatory interactions