Associate Director, Drug Substance

Associate Director role leading late-stage small molecule drug substance development and manufacturing at global CMO/CRO sites. Responsible for process development, regulatory compliance, technology transfer, and commercialization support for early and late-stage pipeline candidates.

Responsibilities

• Oversee all late-stage small molecule drug substance development and manufacturing activities at global CRO/CMO sites
• Lead process development efforts toward commercialization; troubleshoot scale-up and manufacturing issues
• Develop in-process controls, review specifications, batch records, and critical documentation
• Write and review regulatory documents including NDA and MAA submissions
• Collaborate with QC, supply chain, quality assurance, and process chemists to align deliverables

Requirements

• Bachelor's degree in chemical engineering or Ph.D. in organic chemistry
• 7+ years late-stage process development, manufacturing, and tech transfer experience in pharmaceutical industry
• Demonstrated expertise in cGMP, synthetic methodology, scale-up, and process validation
• Proficiency with QbD tools: risk assessment, design of experiments, process analytical technologies
• Strong outsourcing and vendor management experience with external CMO/CRO partners
• Comprehensive analytical chemistry skills including NMR, IR, mass spec, HPLC, GC, and solid-state characterization
• Knowledge of FDA, EMEA, and ICH regulatory guidelines; NDA/MAA filing experience required

Compensation: $145,000 - $207,000