CMC Drug Substance Lead for Small Molecule Programs

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

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.