Director, Drug Product

🕒 Setembro 11

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $200.000 - $260.000 / ano

⏰ Tempo Integral

🔴 Especialista

👔 Diretor

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Enliven Therapeutics

SiteLinkedInTodas as Vagas

11 - 50 funcionários

🏥 Saúde

💼 Consultoria

🧬 Biotecnologia

Healthcare • Consulting • Biotechnology

A Enliven Therapeutics é uma empresa dedicada ao desenvolvimento de soluções inovadoras para o tratamento do câncer. Focam na criação de inibidores de quinase de pequenas moléculas, projetados para melhorar a eficácia, segurança e conveniência para o paciente. Com programas que visam alvos como BCR-ABL, HER2 e vias adicionais, a Enliven Therapeutics busca aprimorar a precisão e a seletividade dos tratamentos contra o câncer, combater a resistência e abordar metástases cerebrais. A empresa se orgulha de ter uma equipe de desenvolvedores de medicamentos experientes e visa ajudar pacientes com câncer a viverem vidas mais longas e melhores.

Descrição

• 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

🎯 Requisitos

• 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

🏖️ Benefícios

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