Associate Director, CMC Drug Substance

Role Summary

Associate Director, CMC Drug Substance at Recursion. The role advances current and future clinical assets through development and ultimately to patients in need. This is an office-based, hybrid position in Salt Lake City, Utah, with expectations to work in the office at least 50% of the time.

Responsibilities

• Lead external drug substance development across the portfolio, including oversight of CDMOs and strategic technical development relationships
• Provide technical leadership, project management, and oversight of drug substance process development and manufacturing activities supporting Recursion’s clinical programs
• Ensure delivery of drug substance from external manufacturing campaigns adhering to current quality guidelines and delivery timelines (typical travel to external manufacturing sites 10-20%)
• Critically analyze process and analytical data to identify and resolve key synthetic challenges during drug substance development
• Participate in developing and extending CDMO relationships, budget planning, and forecasting for drug substance expenditures and quality requirements

Qualifications

• Ph.D. in organic chemistry or closely related field with a minimum of 5–8 years of experience, or M.S. with 8–12 years of experience
• Strong knowledge and experience in small molecule drug substance process development and manufacturing best practices across all phases of drug development (from initial regulatory filings through registration, validation, and launch)
• Prior experience leading external development and CDMO relationships is a plus
• Demonstration of cross-functional understanding related to drug substance development, including salt/polymorph screening, phase-appropriate analytical development, standard process of drug product development, quality, and regulatory affairs
• Well-versed in the latest trends impacting drug substance technology, manufacturing, and the outsourcing industry

Education

• Ph.D. in organic chemistry or closely related field with 5–8 years of experience, or M.S. with 8–12 years of experience

Skills

• External development leadership
• CDMO relationship management
• Project management and strategic planning
• Analytical data interpretation and problem-solving
• Cross-functional collaboration across chemistry, manufacturing, and regulatory domains

Additional Requirements

• Location: Salt Lake City, Utah (office-based, hybrid; in-office at least 50% of the time)
• Travel: 10–20% to external manufacturing sites