This role requires a strong technical background across multiple scientific disciplines and manufacturing/validation fundamentals, including biopharmaceutical best practices, statistical analysis, and regulatory requirements for validation. The role also involves cross-functional collaboration with MSAT leadership, Manufacturing, Quality, and customers to develop and execute the process validation strategy.

Primary Responsibilities

• Responsible for change control impact assessments, investigations, and other quality system deliverables.
• Lead commercial readiness strategies to ensure smooth, efficient, and compliant gene therapy product lifecycles.
• Lead process validation and PPQ activities.
• Perform process risk assessments (e.g., FMEA) and comprehensive gap assessments to identify manufacturing vulnerabilities, regulatory misalignments, or opportunities for optimization.
• Lead and evaluate the manageme...