Manager

• Provide leadership and oversight for team responsible for New Product Introduction (NPI), Process Ownership (PO), Single-Use Systems (SUS), and Cleaning Validation within site manufacturing operations
• Accountable for performance, goals, and management of NPI, PO, SUS, and Cleaning Validation functions to ensure operational readiness and compliance
• Lead site activities to introduce new products and process changes, conduct facility fit assessments, manage change controls, documentation, project management, and cross-functional alignment
• Lead NPI core team meetings to drive scope, schedule, risks, and decisions; present at Tech Transfer Steering Committee (TTSC) meetings
• Oversee process ownership teams responsible for lifecycle management, continuous improvement, and compliance of core manufacturing processes including change controls, CAPAs, and SOPs
• Provide leadership for design, implementation, change management, and ongoing support of Single-Use Systems, including leak and defect management
• Direct cleaning validation programs and activities related to equipment cleaning validation (CIP/COP), sterilization (SIP/Autoclaves), and controlled temperature chambers
• Build, mentor, and develop a high-performing team with clear goals, accountability, and results
• Act as liaison with Manufacturing, Quality, Process Development, Supply Chain, Facilities & Engineering, and Finance to align priorities and execution
• Drive operational excellence, ensure regulatory compliance, and foster a culture of safety, Lean Manufacturing, and continuous improvement

Senior Manager, Manufacturing – Manufacturing Support, Manufacturing Systems

Senior Manager, Manufacturing – Deviation Investigations