Director, Commercial Manufacturing & Process Engineering

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.

Key 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.