Director, Commercial Manufacturing & Process Engineering

Deciphera Pharmaceuticals • Waltham, MA

2h • $184,000 - $253,000 • Remote

About The Position

We are seeking an experienced manufacturing and process engineering leader to support the commercialization and lifecycle management of our commercial-stage pharmaceutical products. Operating within a fully outsourced manufacturing model, this role will oversee commercial manufacturing, technical transfer, process optimization, scale-up, validation, and continuous improvement activities across drug substance and drug product programs. The Director will serve as a key technical and operational leader, partnering cross-functionally with Technical Operations, Quality, Supply Chain, Regulatory, and external CDMO/CMO partners to ensure reliable product supply, regulatory compliance, and operational excellence from late-stage development through commercialization.

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.
• Strong leadership, communication, problem-solving, and stakeholder management skills.
• Ability to travel up to 30% domestically and internationally.

Nice To Haves

• Experience authoring and supporting Module 3 CTD submissions through approval and commercialization preferred.
• Experience supporting oncology and/or orphan disease products.
• Advanced degree or MBA preferred.
• Experience with statistical analysis tools such as JMP is a plus.

Responsibilities

• 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.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Director