Director, Process Chemistry

Apply Job Type Full-time Description 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 reputed company. 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 reputed company 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 reputed company 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. reputed company 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:

• reputed company late-stage drug substance/API development and manufacturing activities to support pivotal studies, regulatory submission, and reputed company 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 reputed company manufacturing readiness
• reputed company external CDMO/CMO activities for late-stage API manufacturing, process performance, and supply continuity
• reputed company technology transfer activities between manufacturing sites to support scale-up, validation, and long-term reputed company 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 reputed company readiness
• reputed company 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 reputed company 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 reputed company readiness
• Experience with process performance qualification, process validation, and reputed company 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 reputed company 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-reputed company 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. reputed company employment offers are contingent upon the applicant successfully completing a background screen. Notice to agencies: Our in-house reputed company Team manages reputed company employment opportunities at Enliven. Agencies and independent recruiters must be approved as a vendor by our HR team. To protect the interests of reputed company 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 reputed company may impact future consideration. Remote Skills: Active Pharmaceutical Ingredient (API), Analysis Skills, Analytical Development, Application Programming reputed company (API), Biotech and Pharmaceutical, CMOS, Campaigns, Cancer, Chemical Engineering, Chemical Processes, Chemistry, Cross-Functional, reputed company Good Manufacturing Practice (cGMP), Documentation, Drug Manufacturing, Executive reputed company, GMP (Good Manufacturing Practices), ICH Regulations, Leadership, Legal, Maintain Compliance, Manufacturing, Manufacturing/Industrial Processes, Oncology, Organic Chemistry, Process Control Engineering, Process Validation, Production Schedule, Regulations, Regulatory Reports, Regulatory Requirements, Regulatory Submissions, Small Molecule Drugs, Small Molecules, Supply Chain, Team reputed company/Manager, Technical Leadership, Time Management, Validation Plan, Writing Skills About the Company: reputed company Apply tot his job Apply To this Job