Director, Process Chemistry — Drug Substance

EPM Scientific; New York (NY); On-site; USD 180,000 - 210,000; Full time

Job summary

EPM Scientific represents a clinical-stage biotechnology client seeking a Director of Drug Substance in New York to lead process chemistry efforts across late preclinical to clinical manufacturing. The role requires managing CDMOs, driving scalable, regulatory-compliant syntheses, and partnering with cross-functional teams to align CMC activities with development timelines.

PhD in Organic Chemistry and 10+ years in pharmaceutical process chemistry are required; strong leadership and

Qualifications

• PhD in Organic Chemistry or Organic Synthesis is required.
• 10+ years of process chemistry or chemical process development experience in pharma/biotech.
• Experience advancing small molecule programs from preclinical to clinical manufacturing.
• Hands-on CDMO/external manufacturing management experience.
• Strong understanding of process development, scale-up, and CMC regulatory requirements.
• Ability to lead in a fast-paced, evolving drug development environment.
• Excellent communication, leadership, and cross-functional collaboration skills.

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.
• Drive development of efficient, scalable, regulatory-compliant synthetic processes to support clinical supply requirements.
• Collaborate with Analytical Development, Formulation, Quality, Regulatory Affairs, Supply Chain, and Project Management teams to align CMC activities with development timelines.
• Contribute to regulatory submission content related to drug substance development, including INDs and amendments.
• Identify technical, manufacturing, and supply chain risks and develop mitigation strategies.
• Provide leadership and mentorship within the technical organization.
• Support longer-term development planning, including late-stage clinical studies and commercial manufacturing readiness.

Skills

Leadership

Project management

Cross-functional collaboration

Regulatory awareness

Education

PhD in Organic Chemistry or Organic Synthesis

Job description

EPM Scientific represents a clinical-stage biotechnology client seeking a Director of Drug Substance in New York to lead process chemistry efforts across late preclinical to clinical manufacturing. The role requires managing CDMOs, driving scalable, regulatory-compliant syntheses, and partnering with cross-functional teams to align CMC activities with development timelines.

PhD in Organic Chemistry and 10+ years in pharmaceutical process chemistry are required; strong leadership and