Associate Director, Drug Substance

Role Overview

• Lead drug substance development activities for NCE programs from preclinical through clinical and commercial stages
• Design, optimize, and scale synthetic routes with focus on efficiency, robustness, cost, and sustainability
• Provide expert input on impurity control strategies, starting material selection, and control of critical process parameters
• Contribute to overall CMC development strategy and timelines for assigned programs
• Author, review, and support drug substance sections of regulatory submissions (IND, CTA, NDA, IMPD)
• Manage and oversee activities at CMOs, including process transfer, scale-up, cGMP manufacturing, and troubleshooting
• Ensure effective communication, technical oversight, and performance management of external partners
• Manage and review deviation events and investigations in coordination with CMC counterparts, QA and regulatory team members
• Represent drug substance function in CMC teams and project meetings, and work closely with cross-functional teams to meet project timelines and goals

Requirements

• PhD or MS degree in Chemistry or Chemical Engineering
• At least 5 years of hands-on experience in small molecule drug development
• Strong understanding of organic synthesis
• Ability to direct and guide the work of CMOs
• Strong understanding of cGMP regulations and manufacturing
• Early-stage development of pre-clinical and clinical API’s experience is highly desirable
• Prior experience in managing internal or external projects is a plus
• Familiarity with US and international regulatory CMC guidance and processes
• Prior experience filing INDs and NDA experience is a plus
• Strong team player with excellent written and verbal communication skills
• Excellent computer skills (e.g., Microsoft Office, Excel, Project)
• Strong organizational skills with attention to detail
• Ability to work both independently and in a team focused environment
• Limited travel may be required (less than 20%)