Director, Commercial Manufacturing – Process Engineering

🕒 Maio 30

🍂 Massachusetts – Remoto

🍂 Massachusetts – Remote

💵 $184.000 - $253.000 / ano

⏰ Tempo Integral

🔴 Especialista

🖥 Engenheiro de Software

🦅 Patrocina Visto H1B

Esta empresa já patrocinou vistos H1B no passado.

Candidatar-se

Encontrar Vagas Remotas Similares

Receber Emails de Vagas Remotas

📊 Verifique sua pontuação de currículo para esta vaga

Melhore suas chances de conseguir uma entrevista verificando sua pontuação de currículo antes de se candidatar.

Enviar Currículo

Deciphera Pharmaceuticals

SiteLinkedInTodas as Vagas

201 - 500 funcionários

Fundada em 2016

🧬 Biotecnologia

💊 Farmacêutico

Biotechnology • Pharmaceuticals

A Deciphera Pharmaceuticals é uma empresa de biotecnologia dedicada a combater o câncer, desenvolvendo inibidores de quinase inovadores para melhorar os resultados dos pacientes. A empresa se concentra em projetar inibidores de quinase de controle de chave para abordar os mecanismos de resistência tumoral e farmacológica, com o objetivo de aprimorar as respostas ao tratamento para pacientes com câncer. A Deciphera possui um portfólio diversificado de candidatos a medicamentos, incluindo ripretinibe e vimseltinibe, e está comprometida em causar um impacto significativo na vida dos pacientes com câncer. A partir de junho de 2024, a Deciphera é uma subsidiária integral da ONO Pharma e continua a trabalhar para melhorar a saúde humana por meio de suas inovações científicas e abordagem centrada no paciente.

Descrição

• 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.

🎯 Requisitos

• 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.

🏖️ Benefícios

• 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.