Associate Director, CMC Drug Substance

Latigo Biotherapeutics, Inc.; Thousand Oaks (CA); On-site; USD 180,000 - 240,000; Full time

Job summary

Latigo Biotherapeutics, Inc. seeks an Associate Director of CMC, Drug Substance to lead development activities from preclinical through clinical and commercial stages, design scalable routes, and guide impurity control strategies.

You will coordinate with CDMOs, ensure cGMP compliance, contribute to regulatory submissions, manage external partnerships, and work with cross-functional teams to meet program timelines.

Qualifications

• Ph.D. or M.S. in Chemistry or Chemical Engineering with 5+ years in small molecule drug development.
• Strong organic synthesis knowledge and ability to guide CDMOs.
• Solid understanding of cGMP regulations and manufacturing.
• Experience in early-stage development of API for preclinical/clinical.
• Experience managing internal or external projects.

Responsibilities

• Lead drug substance development from preclinical through clinical and commercial stages.
• Design, optimize, and scale synthetic routes focusing on efficiency, robustness, cost.
• Provide input on impurity control, starting material selection, and critical process parameters.
• Contribute to CMC development strategy and timelines.
• Prepare and support drug substance sections of regulatory submissions (IND, CTA, NDA, IMPD).
• Oversee CDMOs: route scouting, tech transfer, scale-up, and cGMP manufacturing.
• Ensure communication and performance management of external partners.
• Review deviations and investigations with CMC, QA, and regulatory teams.
• Represent DS in CMC teams and coordinate with cross-functional groups to meet timelines.

Skills

Drug substance development

Organic synthesis

cGMP knowledge

Regulatory submissions input

Cross-functional collaboration

Project management

Education

PhD in Chemistry or Chemical Engineering

MS in Chemistry or Chemical Engineering

Tools

ChemDraw

Microsoft Office

Job description

Position Description

Latigo is searching for an Associate Director CMC, Drug Substance. Reporting to the Senior Director of Drug Substance and Development, the Associate Director will assist in the process development and cGMP drug substance manufacturing for Latigo's small molecule clinical pipeline.

Job responsibilities

• Lead drug substance development activities for New Chemical Entity 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 Contract Development and Manufacturing Organizations, including route scouting, 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

• Ph.D. or M.S. 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 Contract Development and Manufacturing Organizations.


• Strong understanding of cGMP regulations and manufacturing.


• Early-stage development of pre-clinical and clinical Active Pharmaceutical Ingredients 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., ChemDraw, Microsoft Office, etc.)


• 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 (less than 20%) may be required.