Director, Process Chemistry

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Enliven Therapeutics

WebsiteLinkedInAlle Stellen

11 - 50 Mitarbeiter

🧬 Biotechnologie

💊 Pharmazie

⚕️ Krankenversicherung

Biotechnology • Pharmaceuticals • Healthcare Insurance

Enliven Therapeutics ist ein Unternehmen, das sich der Entwicklung innovativer Lösungen für die Krebsbehandlung widmet. Es konzentriert sich auf die Entwicklung von kleinen Molekül-Kinase-Inhibitoren, die darauf abzielen, die Wirksamkeit, Sicherheit und den Komfort für Patienten zu verbessern. Mit Programmen, die auf BCR-ABL, HER2 und zusätzliche Signalwege abzielen, strebt Enliven Therapeutics an, die Präzision und Selektivität von Krebstherapien zu erhöhen, Resistenzen zu bekämpfen und Hirnmetastasen anzugehen. Das Unternehmen ist stolz auf ein Team erfahrener Arzneimittelentwickler und möchte Krebspatienten dabei helfen, länger und besser zu leben.

Beschreibung

• 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

🎯 Anforderungen

• 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.

🏖️ Vorteile

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