Latigo Biotherapeutics, Inc. · 23 hours ago
Associate Director, Drug Substance
Thousand Oaks, CA
Full-time
Onsite
Lead/Staff
5+ years expLatigo 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. The Associate Director will assist in the development and GMP drug substance manufacturing for Latigo’s small molecule clinical pipeline, leading drug substance development activities and managing CMO relationships.
BiotechnologyHealthcareHealth CareMedicalTherapeutics
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
Qualification
Required
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
Preferred
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%)
Company
Latigo Biotherapeutics, Inc.
Latigo Biotherapeutics Inc., headquartered in Thousand Oaks, CA, is a privately held clinical-stage biotechnology company developing best-in-class non-opioid pain medicines that target the fundamental mechanism of pain transduction.
11-50 employees
H1B Sponsorship
Latigo Biotherapeutics, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
Funding
Current Stage
Growth StageTotal Funding
$300MKey Investors
Blue Owl5AM Ventures,Foresite Capital,Westlake Village BioPartnersCorner Ventures
2025-03-17Series B· $150M
2024-02-14Series A· $135M
2020-08-21Series Unknown· $15M
Leadership Team
Nima Farzan
Chief Executive Officer
Tim Lugo
Chief Financial Officer
Recent News
BioWorld Financial Watch
2026-01-17
Company data provided by crunchbase