Director, Process Chemistry

Job Description

Enliven Therapeutics is seeking a Director of Process Chemistry to oversee late-stage drug substance/API development and manufacturing activities, ensuring they support pivotal studies, regulatory submissions, and commercial launch readiness. This role involves defining and executing phase-appropriate API strategies aligned with program milestones and submission goals. You will ensure robust process designs and control strategies are in place to support pivotal trials, registration, and commercial manufacturing readiness. Responsibilities include: * Overseeing external CDMO/CMO activities for late-stage API manufacturing, process performance, and supply continuity. * Leading technology transfer activities between manufacturing sites to support scale-up, validation, and long-term commercial supply. * Driving process characterization, CPP identification, validation planning, and PPQ readiness/execution for late-stage programs. * Establishing, maintaining, and refining API control strategies, specifications, and supporting documentation for regulatory submission and commercial readiness. * Overseeing drug substance manufacturing campaigns, scheduling, site readiness, and operational execution to ensure timely supply for clinical and registration-enabling activities. * Authoring, reviewing, and approving technical reports and GMP documentation. * Partnering closely with cross-functional teams to ensure cGMP compliance, inspection readiness, and successful health authority interactions. * Representing CMC/DS/API needs to the core development team.

Qualifications

To be considered for the Director of Process Chemistry role, candidates should meet the following requirements: 1. Possess an MS or PhD in Organic Chemistry, Chemistry, Chemical Engineering, or a related scientific discipline. 2. Have 10+ years of relevant experience in the pharmaceutical or biotechnology industry, with significant hands-on experience in small molecule drug substance/API development and commercialization. 3. Demonstrate strong late-stage development experience supporting Phase 3 programs through NDA/BLA or equivalent regulatory submission. 4. Exhibit deep technical expertise in small molecule API process chemistry, development, and scale-up. 5. Have demonstrated experience leading drug substance manufacturing activities in support of late-stage development and commercial readiness. 6. Experience with process performance qualification, process validation, and commercial launch preparation is essential. 7. Demonstrate a deep understanding of impurity control strategies, including ICH Q3A/Q3B and ICH M7. 8. Possess a strong working knowledge of cGMP requirements and global regulatory expectations, including ICH Q7, Q11, and Q2. 9. Experience authoring, reviewing, or contributing to Module 3 and other CMC documentation for regulatory submissions is required. 10. Proven readiness to support regulatory inspections, ensure reliable API supply, and deliver successful outcomes across PPQ, submission, and commercial manufacturing.

Benefits

Enliven Therapeutics offers a comprehensive benefits package, which may include: - Health insurance - Paid time off - Retirement plan - Other incentives such as bonus and equity.