Oversee late-stage drug substance/API development and manufacturing activities to support pivotal studies, regulatory submission, and commercial launch readiness
Help define and execute phase-appropriate API strategy for late-stage development, ensuring alignment with program milestones and submission goals
Ensure process design and control strategy are sufficiently established to support pivotal trials, registration, and commercial manufacturing readiness
Oversee external CDMO/CMO activities for late-stage API manufacturing, process performance, and supply continuity
Lead technology transfer activities between manufacturing sites to support scale-up, validation, and long-term commercial supply
Drive process characterization, CPP identification, validation planning, and PPQ readiness/execution for late-stage programs
Establish, maintain, and refine API control strategy, specifications, and supporting documentation for regulatory submission and commercial readiness
Oversee drug substance manufacturing campaigns, scheduling, site readiness, and operational execution to ensure timely supply for clinical and registration-enabling activities
Author, review, and approve technical reports and GMP documentation, including batch records, protocols, specifications, campaign reports, and regulatory CMC submission content
Partner closely with Quality, Regulatory CMC, Supply Chain, Analytical, Formulation, Legal, and external manufacturers to ensure cGMP compliance, inspection readiness, and successful health authority interactions
Help represent CMC/DS/API needs to core development team

Requirements

MS or PhD in Organic Chemistry, Chemistry, Chemical Engineering, or a related scientific discipline
10+ years of relevant experience in the pharmaceutical or biotechnology industry, including significant hands-on experience in small molecule drug substance/API development and commercialization
Strong late-stage development experience supporting Phase 3 programs through NDA/BLA or equivalent regulatory submission
Deep technical expertise in small molecule API process chemistry, development, and scale-up
Demonstrated experience leading drug substance manufacturing activities in support of late-stage development and commercial readiness
Experience with process performance qualification, process validation, and commercial launch preparation
Deep understanding of impurity control strategies, including ICH Q3A/Q3B and ICH M7
Strong working knowledge of cGMP requirements and global regulatory expectations, including ICH Q7, Q11, and Q2
Experience authoring, reviewing, or contributing to Module 3 and other CMC documentation for regulatory submissions
Proven readiness to support regulatory inspections, ensure reliable API supply, and deliver successful outcomes across PPQ, submission, and commercial manufacturing.

Benefits

Benefits are included and other incentives such as bonus and equity may be provided.

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

API developmentdrug substance manufacturingprocess validationprocess performance qualificationscale-upimpurity control strategiescGMP complianceregulatory submissionstechnical report authoringprocess characterization

Soft Skills

leadershipcollaborationcommunicationproblem-solvingstrategic planningproject managementattention to detailorganizational skillsinterpersonal skillsadaptability