Enliven Inc. - Director, Process Chemistry

Enliven Inc.

Position Title: Director, Process Chemistry

Job Status: Exempt, Full Time

Location: Remote

Department: CMC

Company Overview

Enliven Therapeutics is a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule inhibitors to help people with cancer not only live longer but live better. The Company aims to address existing and emerging unmet needs with a precision oncology approach that improves survival and enhances overall well-being. Its discovery process combines deep insights in clinically validated biological targets and differentiated chemistry with the goal of designing therapies for unmet needs.

Summary

Enliven is seeking a Process Chemistry Lead to serve as the drug substance/API subject matter expert, defining and executing phase-appropriate CMC strategy to advance product candidates through late-stage development, pivotal trials, and potential commercial launch. Establish and maintain the API control strategy, including specifications and process controls, ensuring they are locked for pivotal studies and regulatory submission. Review and approve technical reports and GMP documentation such as batch records, protocols, campaign reports, specifications, and regulatory filing content. Oversee drug substance scheduling and manufacturing campaigns, ensure cGMP compliance and inspection readiness, and represent drug substance/API priorities on core cross-functional teams. Partner closely with CMOs and internal teams across Quality, Supply Chain, Regulatory CMC, Formulation, and Analytical Development to drive operational excellence and timely release of drug substance for clinical use.

Responsibilities

• 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

• 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

The annual salary range Enliven reasonably and in good faith expects to pay for this position at the time of this posting is $190,000 – $238,000. The actual salary offered will be determined based on factors such as experience, qualifications, skills and expertise, geographic location, and other job-related factors permitted by law. Benefits are included and other incentives such as bonus and equity may be provided. This range is subject to change based on business needs, job scope changes, market conditions, and individual qualifications. Employees and applicants may request the pay range for their position or for a position to which they are applying.

Enliven Therapeutics is proud to be an equal opportunity employer. All employment offers are contingent upon the applicant successfully completing a background screen.

Notice to agencies: Our in-house Talent Acquisition Team manages all employment opportunities at Enliven. Agencies and independent recruiters must be approved as a vendor by our HR team. To protect the interests of all parties, Enliven will not accept unsolicited resumes, profiles, or biographies. Any unsolicited submissions will be considered referrals and become the property of Enliven. Contacting hiring managers, executives, or any member of the HR team will not influence vendor approval and is strongly discouraged. Repeated outreach may impact future consideration.