Director, Commercial Manufacturing – Process Engineering

🕒 il y a 2 mois

🍂 Massachusetts – Distant

🍂 Massachusetts – Remote

💵 $184 000 - $253 000 / an

⏰ Temps Plein

🔴 Expert

🖥 Ingénieur Logiciel

🦅 Parrain de Visa H1B

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Deciphera Pharmaceuticals

Site WebLinkedInTous les Emplois

201 - 500 employés

Fondée en 2016

🏥 Santé

🏭 Fabrication

🧬 Biotechnologie

Healthcare • Manufacturing • Biotechnology

Deciphera Pharmaceuticals est une entreprise de biotechnologie dédiée à vaincre le cancer en développant des inhibiteurs de kinase innovants pour améliorer les résultats des patients. L'entreprise se concentre sur la conception d'inhibiteurs de kinase à contrôle de commutateur pour traiter les mécanismes de résistance tumorale et médicamenteuse, visant à améliorer les réponses aux traitements pour les patients atteints de cancer. Deciphera possède un portefeuille diversifié de candidats médicaments, y compris ripretinib et vimseltinib, et s'engage à avoir un impact significatif sur la vie des patients atteints de cancer. Depuis juin 2024, Deciphera est une filiale à part entière de ONO Pharma et continue de travailler à l'amélioration de la santé humaine grâce à ses innovations scientifiques et son approche centrée sur le patient.

Description

• Lead day-to-day oversight of commercial manufacturing operations, process engineering activities, and continuous improvement initiatives. • Drive process optimization, troubleshooting, scale-up, PPQ, validation, and lifecycle management activities for commercial products. • Support regulatory CMC strategy, including development and review of Module 3 CTD submissions and health authority responses. • Oversee CDMO/CMO relationships, ensuring strong technical, operational, quality, and regulatory performance across the supply chain. • Partner cross-functionally to support successful product launches, technology transfers, supply chain expansion, and post-approval improvements. • Lead operational improvement initiatives utilizing Lean/Six Sigma methodologies to improve efficiency, reduce costs, and enhance manufacturing performance. • Manage project timelines, deliverables, and budgets while ensuring alignment with overall business and technical operations strategy.

🎯 Exigences

• Bachelor’s or Master’s degree in Chemical Engineering, Pharmaceutics, Chemistry, or related life sciences discipline. • 10+ years of experience in pharmaceutical or biopharmaceutical CMC development, commercialization, and manufacturing. • Strong experience managing drug substance and/or drug product manufacturing programs in regulated environments. • Demonstrated success working with CDMO/CMO partners and leading cross-functional technical operations initiatives. • Deep knowledge of cGMPs, process validation, regulatory CMC requirements, and global drug development processes. • Experience authoring and supporting Module 3 CTD submissions through approval and commercialization preferred. • Strong leadership, communication, problem-solving, and stakeholder management skills. • Ability to travel up to 30% domestically and internationally.

🏖️ Avantages

• Competitive salary and annual bonus. • Comprehensive benefits package including medical, dental, vision insurance, 401(k) retirement plan with company match, and more. • Generous parental leave and family planning benefits. • Outstanding culture and opportunities for personal and professional growth.