Director, Drug Product

Description

Position: Director, Drug Product

Department: CMC

Location: Remote

Status: Full-time Exempt

About Us

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 medicine 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.

Role Summary

We are seeking an experienced Director, Drug Product to provide technical, strategic, and operational leadership for small molecule drug product development and manufacturing across Enliven’s portfolio. This individual will lead phase-appropriate formulation and process development activities from early clinical development through late-stage development and commercialization, including scale-up, technology transfer, process characterization, validation, and lifecycle management.

The Director will serve as Enliven’s drug product subject matter expert and lead technical oversight of external development and manufacturing partners. This role will partner closely with internal CMC, Analytical Development, Quality, Regulatory, Clinical Supply, and program teams to ensure robust drug product strategies and the reliable delivery of clinical and future commercial supplies. The successful candidate will combine strong scientific and technical judgment with a hands-on, pragmatic approach suited to a fast-paced and highly outsourced biotechnology environment.

The role reports to the SVP, CMC and Supply Chain.

Core Responsibilities

• •Lead drug product CMC strategy and execution for small molecule programs from early clinical development through late-stage development, registration, commercialization, and lifecycle management
• •Lead phase-appropriate formulation and process development activities for oral solid dosage forms, including formulation selection and optimization, manufacturing process development, scale-up, and establishment of appropriate control strategies
• •Provide technical leadership for drug product technology transfers, process characterization, process validation, and manufacturing readiness activities
• •Lead the selection, onboarding, and technical oversight of CDMOs and other external partners responsible for drug product development, manufacturing, packaging, and related activities
• •Establish clear expectations, work plans, timelines, budgets, and performance measures for external partners and hold CDMOs accountable for quality, timing, and delivery
• •Provide technical oversight of GMP manufacturing campaigns, including review of batch documentation, manufacturing performance, deviations, investigations, change controls, and corrective and preventive actions
• •Analyze and interpret formulation, manufacturing, analytical, and stability data to identify trends, troubleshoot technical issues, assess risks, and guide product and process decisions
• •Develop robust and phase-appropriate drug product manufacturing processes and control strategies that support product quality, scalability, supply continuity, and regulatory expectations
• •Partner closely with Analytical Development, Quality, Regulatory CMC, Clinical Supply, and other CMC functions to develop integrated product development, manufacturing, and supply strategies
• •Support clinical supply planning and execution by ensuring alignment among drug product development, manufacturing schedules, packaging requirements, stability programs, and clinical timelines
• •Author and review drug product sections of regulatory submissions, technical reports, development plans, specifications, risk assessments, and other CMC documentation
• •Apply relevant FDA, EMA, ICH, cGMP, and global regulatory expectations to drug product development and manufacturing activities and support health authority interactions as needed
• •Develop and maintain program plans, budgets, timelines, and risk assessments for drug product activities, proactively communicating issues and recommending mitigation strategies
• •Communicate technical risks, recommendations, and business implications clearly to cross-functional teams and senior leadership
• •Contribute to technical due diligence, product evaluations, and broader CMC strategy as needed
• •Stay current with advances in small molecule drug product development, manufacturing technologies, regulatory expectations, and industry best practices
• •Help curate a strong patient-focused department and company culture

Requirements

• •Advanced degree in Pharmaceutical Sciences, Chemical Engineering, Chemistry, Pharmaceutics, or a related discipline with 10+ years of relevant experience in the pharmaceutical or biotechnology industry; equivalent combinations of education and experience will be considered
• •Demonstrated experience leading therapeutic product formulation and process development
• •Strong technical experience spanning formulation development, process development, scale-up, technology transfer, process characterization, validation, and GMP manufacturing support
• •Experience supporting drug product development from early clinical stages through late-stage development and commercialization; commercial launch or commercial manufacturing experience is highly preferred
• •Demonstrated success managing CDMOs and external development and manufacturing partners in a highly outsourced operating model
• •Strong working knowledge of drug product manufacturing processes, pharmaceutical analytical testing, stability programs, specifications, and control strategies
• •Ability to interpret complex manufacturing, analytical, and stability data and translate findings into sound technical and business decisions
• •Strong understanding of cGMP requirements, ICH guidelines, and global regulatory expectations for pharmaceutical development and manufacturing
• •Experience authoring and reviewing CMC regulatory submission content and supporting responses to health authority questions
• •Proven ability to lead investigations, troubleshoot manufacturing and product performance issues, and implement pragmatic risk-mitigation strategies
• •Strong scientific judgment and the ability to balance technical requirements, product quality, regulatory expectations, timelines, cost, and supply considerations
• •Demonstrated ability to influence cross-functional stakeholders and external partners without direct authority
• •Excellent written, verbal, and presentation skills, including the ability to communicate complex technical issues clearly to senior leadership
• •Comfortable operating independently and working hands-on in a fast-paced, agile, and growing biotechnology company

The expected salary range for this position is: $200k - $260k. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.

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.