Mr. Stock has +35 years of process/operations and compliance experience in the pharmaceutical, biotech and medical device industries. He has started-up, commissioned and validated cell culture, vaccines, oral solids and liquids, bulk chemical and medical device facilities. His direct experience encompasses facility and system design and qualifications, including process validation and process development. Direct operations and compliance experience (owner side) includes start-up and line management in aseptic processing, blood component processing, in-vitro diagnostics manufacturing, dry powder processing, lyophilization processes, cell culture (small and large scale) and protein processing. He has recently implemented Lean/Value driven approaches for quality system implementations/renovations to remove waste and “right size compliance” as well as streamlining engineering and qualification quality system elements based on current ASTM E2500 and ISPE standards and guides. He has led several manufacturers in employing Risk Management Practices in decision making related to compliance, product quality, technology transfer and implementation of Lean.