Director, Commercial Manufacturing – Process Engineering

🕒 4 days ago

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $184k - $253k / year

⏰ Full Time

🔴 Lead

🖥 Software Engineer

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Deciphera Pharmaceuticals

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2016

🧬 Biotechnology

💊 Pharmaceuticals

Biotechnology • Pharmaceuticals

Deciphera Pharmaceuticals is a biotechnology company dedicated to defeating cancer by developing innovative kinase inhibitors to improve patient outcomes. The company focuses on designing switch-control kinase inhibitors to address mechanisms of tumor and drug resistance, aiming to enhance treatment responses for patients with cancer. Deciphera has a diverse pipeline of drug candidates, including ripretinib and vimseltinib, and is committed to making a significant impact on the lives of cancer patients. As of June 2024, Deciphera is a wholly-owned subsidiary of ONO Pharma and continues to work on improving human health through its scientific innovations and patient-centric approach.

📋 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.

🎯 Requirements

• 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.

🏖️ Benefits

• 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.