Associate Director, Drug Substance

Job Title

Associate Director, Drug Substance

CMC

Thousand Oaks, CA or San Francisco, CA

Full Time

Director of Drug Substance and Development

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 experienced Board of Directors. At Latigo, we value science, patient-focus, and innovation.

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.

• 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.

• 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.

• 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%).