Manager, Project Management - MS & T Support

The Manager, Project Management is responsible for leading and coordinating project management activities that support post‑commercial launch and product lifecycle management projects at the commercial manufacturing site.

This role partners closely with MS&T, Manufacturing Operations, Quality, Engineering, Supply Chain, and Site Leadership to ensure effective execution of lifecycle changes, process optimization initiatives, validation activities, and supply continuity projects.

The role ensures projects are planned, governed, and executed in compliance with GMP and site quality systems while minimizing risk, maintaining commercial supply, and enabling continuous improvement of commercial manufacturing processes.

• Lead and manage post‑commercial launch and product lifecycle MS&T projects, including post‑approval process changes, continuous improvement initiatives, yield, robustness, and cost optimization efforts, and post‑launch technical remediation activities.
• Develop and maintain integrated project plans, timelines, milestones, and dependencies that support manufacturing stability and effective lifecycle execution.
• Serve as the central point of coordination for MS&T‑led lifecycle initiatives, partnering closely with Manufacturing Operations, Quality Assurance and Quality Control, Engineering and Automation, and Supply Chain, Planning, and Scheduling.
• Drive cross‑functional alignment to ensure lifecycle project execution is integrated with routine commercial manufacturing and production schedules.
• Plan, coordinate, and manage execution of engineering, validation, and re‑validation activities, CPV‑related initiatives, and change control–driven lifecycle workstreams.
• Ensure operational, quality, and technical readiness for lifecycle changes by confirming availability and alignment of approved change controls, validation strategies and protocols, resource capacity, and production timing.
• Implement standardized project management tools and governance to track progress against milestones, manage interdependencies, identify, assess, and mitigate technical, compliance, and supply risks.
• Proactively escalate risks, issues, and decision needs that may impact product quality, regulatory compliance, manufacturing performance, or supply continuity.
• Prepare and deliver regular project status updates to site and functional leadership, clearly communicating progress versus plan, key risks and mitigations, decision points, and potential impacts to operations and supply.
• Document meeting minutes, action items, and key decisions to ensure transparency, accountability, and effective execution.
• Ensure all project activities are executed in compliance with site quality systems and applicable GMP requirements.
• Support MS&T and Quality teams in the coordination and completion of validation documentation, lifecycle change execution packages, and project readiness and closure summaries, maintaining organized and inspection‑ready project records.
• Support MS&T‑led initiatives focused on improving process capability and robustness, operational efficiency, cycle time, and right‑first‑time execution, capturing and communicating lessons learned to strengthen future lifecycle project delivery.