Director of Drug Substance

Overview: Our client is a clinical-stage biotechnology company advancing a pipeline of innovative small molecule therapies for diseases with significant unmet medical need. As the organization continues to expand its technical operations and CMC capabilities, they are seeking a Director of Process Chemistryto support the advancement of drug substance development across multiple programs. This individual will provide scientific and operational leadership for process chemistry activities, working closely with external manufacturing partners and internal cross-functional teams to progress compounds from late preclinical development through clinical stages.

Key Responsibilities: Lead process chemistry activities for small molecule drug candidates, including route selection, process optimization, scale-up, and process characterization. Manage external CDMOs and development partners, providing technical oversight for process development, manufacturing campaigns, technology transfers, and troubleshooting efforts. Drive the development of efficient, scalable, and regulatory-compliant synthetic processes to support clinical supply requirements. Collaborate with Analytical Development, Formulation, Quality, Regulatory Affairs, Supply Chain, and Project Management teams to ensure alignment of CMC activities with development timelines. Contribute to the preparation and review of regulatory submission content related to drug substance development, including INDs, amendments, and supporting documentation. Identify technical, manufacturing, and supply chain risks and develop mitigation strategies to support successful program execution. Provide leadership and mentorship within the technical organization while helping establish best practices across process development activities. Support longer-term development planning, including preparations for late-stage clinical studies and commercial manufacturing readiness. Qualifications & ExperiencePhD in Organic Chemistry or Organic Synthesis required 10+ years of experience in process chemistry or chemical process development within the pharmaceutical or biotechnology industry. Demonstrated experience advancing small molecule programs from preclinical development into clinical-stage manufacturing. Hands-on experience managing CDMOs and external manufacturing networks. Strong understanding of process development, scale-up, manufacturing operations, and CMC regulatory requirements. Ability to operate effectively in a fast-paced, evolving environment with multiple development programs. Excellent communication, leadership, project management, and cross-functional collaboration skills. Proven ability to influence technical strategy and execute against aggressive development timelines.

Preferred Qualifications: Experience supporting Phase 2/Phase 3 development programs and commercial process readiness activities. Track record of working within emerging biotechnology organizations and contributing to the growth of technical development functions. Knowledge of global regulatory expectations for small molecule drug substance development and manufacturing.