Associate Director, CMC Drug Substance

Latigo Creative

. Lead drug substance development activities for New Chemical Entity programs from preclinical through clinical and commercial stages .

Posted 10/8/2026full-timeThousand Oaks • California • United StatesSenior💰 $200,000 - $220,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in drug substance development, including organic synthesis, cGMP regulations, and regulatory submissions. Proven ability to manage cross-functional teams and oversee Contract Development and Manufacturing Organization activities to ensure project success.

Highest-signal resume keywords

Ph.D. Or M.S. Degree In Chemistry Or Chemical EngineeringSmall Molecule Drug Development ExperienceOrganic Synthesis ExpertiseCGMP Regulations KnowledgeIND And NDA Filing Experience

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Drug Substance DevelopmentSynthetic Route DesignImpurity Control StrategiesProcess Parameter ControlRegulatory Submissions AuthoringProject ManagementActive Pharmaceutical Ingredients DevelopmentDeviation Event ManagementTechnical OversightProcess Transfer And Scale-Up

Soft Skills

Excellent Written And Verbal CommunicationStrong Organizational SkillsAttention To DetailTeam PlayerAbility To Work Independently

Tools & Technologies

ChemDrawMicrosoft Office

Industry Keywords

Contract Development And Manufacturing OrganizationCGMP ManufacturingCMC Development StrategyRegulatory CMC GuidancePreclinical And Clinical Development

About the role

Key responsibilities & impact

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, including IND, CTA, NDA, and IMPD
Manage and oversee Contract Development and Manufacturing Organization activities, 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 the drug substance function in CMC teams and project meetings
Work closely with cross-functional teams to meet project timelines and goals
Report to the Senior Director of Drug Substance and Development

Requirements

What you’ll need

Ph.D. or M.S. degree in Chemistry or Chemical Engineering
At least 5 years of hands-on experience in small molecule drug development
Strong understanding of organic synthesis
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
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 and Microsoft Office
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

Benefits

Comp & perks

Limited travel (less than 20%) may be required