Clinical and commercial manufacturing subject matter expert experienced in cell culture, purification, aseptic filling, quality, medical devices, pre-approval inspections, commissioning facilities, disposable technologies, combination products, and transfer of technology.Specialties: Operational Excellence, Experience in Lean Manufacturing, Kaizen events, MDI (manufacturing daily improvements) metrics, and 5S organizational methodology. White Belt Certified.Deviation Management: Versed in TrackWise and SmartSolve software applications as well as Root Cause Analysis, Cause and Effect Diagrams, and implementation of corrective and preventive actions