Director, Process Chemistry

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Enliven Therapeutics

SiteLinkedInTodas as Vagas

11 - 50 funcionários

🧬 Biotecnologia

💊 Farmacêutico

⚕️ Seguro de Saúde

Biotechnology • Pharmaceuticals • Healthcare Insurance

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

• 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

🎯 Requisitos

• 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.

🏖️ Benefícios

• Benefits are included and other incentives such as bonus and equity may be provided.