Director, Drug Product

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $200k - $260k / year

⏰ Full Time

🔴 Lead

👔 Director

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Enliven Therapeutics

WebsiteLinkedInAll Job Openings

11 - 50 employees

🏥 Healthcare

💼 Consulting

🧬 Biotechnology

Healthcare • Consulting • Biotechnology

Enliven Therapeutics is a company dedicated to developing innovative solutions for cancer treatment. They focus on creating small molecule kinase inhibitors designed to improve efficacy, safety, and patient convenience. With programs targeting BCR-ABL, HER2, and additional pathways, Enliven Therapeutics aims to enhance the precision and selectivity of cancer therapeutics, combat resistance, and address brain metastases. The company prides itself on a team of experienced drug developers and aims to help cancer patients live longer and better lives.

📋 Description

• 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 for oral solid dosage forms, including formulation selection and optimization, manufacturing process development, scale-up, and control strategies • Provide technical leadership for technology transfers, process characterization, process validation, and manufacturing readiness • Select, onboard, and technically oversee CDMOs and external partners for drug product development, manufacturing, packaging, and related activities • Establish 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 batch documentation, manufacturing performance, deviations, investigations, change controls, and corrective and preventive actions • Analyze formulation, manufacturing, analytical, and stability data to identify trends, troubleshoot issues, assess risks, and guide product and process decisions • Develop drug product manufacturing processes and control strategies supporting quality, scalability, supply continuity, and regulatory expectations • Partner with Analytical Development, Quality, Regulatory CMC, Clinical Supply, and other CMC functions on integrated development, manufacturing, and supply strategies • Support clinical supply planning and execution by aligning development, manufacturing schedules, packaging, 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 FDA, EMA, ICH, cGMP, and global regulatory expectations and support health authority interactions • Develop and maintain program plans, budgets, timelines, and risk assessments; communicate issues and recommend mitigation strategies • Communicate technical risks, recommendations, and business implications to cross-functional teams and senior leadership • Contribute to technical due diligence, product evaluations, and broader CMC strategy • 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 • Report to the SVP, CMC and Supply Chain

🎯 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 ability to balance technical requirements, product quality, regulatory expectations, timelines, cost, and supply considerations • 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 • Successful completion of a background screen

🏖️ Benefits

• Discretionary annual bonus may be available based on individual and Company performance • Equal opportunity employer • Full-time exempt position