Associate Director, CMC Drug Substance

Location: Thousand Oaks, California, United States (Hybrid)

Company

hirify.global develops small molecule clinical programs and their associated drug substances.

What you will do

• Lead drug substance development for new chemical entity programs from preclinical development through clinical and commercial stages.
• Design, optimize, and scale synthetic routes with emphasis on efficiency, robustness, cost, and sustainability.
• Develop impurity control strategies, select starting materials, and control critical process parameters.
• Contribute to CMC development strategies, timelines, and regulatory submissions including IND, CTA, NDA, and IMPD filings.
• Manage CDMO activities including route scouting, process transfer, scale-up, cGMP manufacturing, troubleshooting, and performance oversight.
• Represent the drug substance function in CMC and project teams while coordinating deviations, investigations, QA, regulatory, and cross-functional activities.

Requirements

• Ph.D. or M.S. degree in Chemistry or Chemical Engineering.
• At least 5 years of hands-on experience in small molecule drug development.
• Strong knowledge of organic synthesis, cGMP regulations, and manufacturing.
• Experience directing and guiding Contract Development and Manufacturing Organizations.
• Strong written and verbal communication, organizational, computer, and project management skills.
• Ability to work independently and collaboratively while managing multiple projects.

Nice to have

• Experience with early-stage development of preclinical and clinical active pharmaceutical ingredients.
• Familiarity with US and international regulatory CMC guidance and processes.
• Prior IND filing or NDA experience.
• Experience managing internal or external projects.

Culture & Benefits

• Hybrid work arrangement in Thousand Oaks, California.
• Limited travel may be required, less than 20%.
• Cross-functional collaboration with CMC, QA, regulatory, and external manufacturing partners.