Job Description
Job DescriptionSalary: $180,000 - $200,000
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 Latigos 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 APIs 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%)