Director

• Develop and execute the global strategy for cell therapy manufacturing process changes, ensuring alignment with commercial and CMC objectives.
• Own the technical project portfolio for designated cell therapy products, managing schedules, budgets, and resources.
• Lead cross-functional matrix teams to deliver process transformation, improvement, and cost reduction initiatives.
• Drives alignment across CTTO, analytical, quality, regulatory, operations, development, supply chain, program strategy, third-party manufacturing, and manufacturing sites.
• Implements lifecycle management projects and harmonizes manufacturing processes across multiple sites.
• Lead Manufacturing Success Rate (MSR), Robustness, and Cost Reduction initiatives to ensure reliable drug product supply and continuous commercial process transformation.
• Oversee process validation, technology transfer, process qualification, and comparability strategies.
• Lead continuous improvement projects and change control management to enhance product quality, compliance, and supply reliability.
• Lead and oversee the technical package, including project and process risk assessments, governance presentations, and standalone actions to ensure effective project execution.
• Lead and oversee global change controls, CAPAs, proactive initiatives, and standalone actions to maintain compliance and drive improvement.
• Author and review technical content for regulatory submissions (e.g., PPQ, comparability assessments), annual product quality reviews, and technical reports.
• Manage and mentor a technical team, assigning projects and tasks based on strategic priorities.
• Foster a culture of accountability, inclusion, integrity, and innovation.
• Promote diversity, equity, and inclusion in team composition and project execution.

Associate Director – Drug Product Lifecycle Management

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