Associate Director, Drug Substance

Job Title: Associate Director, Drug Substance Department: CMC Location: Thousand Oaks, CA or San Francisco, CA Position Type: Full Time Reporting to: Director of Drug Substance and Development Company Description: Latigo Biotherapeutics, Inc. is a private, early-stage biotechnology company focused on discovering and developing the next generation of non-opioid medicines for pain and pain-related syndromes. Our mission is the development of novel therapies that transform the lives of patients. The company is headquartered in Thousand Oaks, CA and has a highly successful management team and an experiencedBoard of Directors. At Latigo, we value science, patient-focus, and innovation. Position Description: Latigo is searching for an Associate Director of Drug Substance Development/CMC. Reporting to the Director of Drug Substance and Development, the Associate Director will assist in the development and GMP drug substance manufacturing for Latigo's small molecule clinical pipeline. Job responsibilities Lead drug substance development activities for NCE programs from preclinical through clinical and commercial stages. Design, optimize, and scale synthetic routes with a 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 Experience and Required Skills: PhD or MS degree in Chemistry or Chemical Engineering, and at least 5 years of hands-on experience in small molecule drug development Strong understanding of organic synthesis and 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 either internal or external projects is a plus Additional Skills/Preferences: 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 and ability to manage multiple projects at once Ability to work both independently and in a team focused environment Limited travel may be required (less than 20%)

Created: 2026-03-04