Employee of Johnson & Johnson for more than 37 years prior to retirement with a proven record of designing and implementing innovative organizational synergy to proactively address changing Development and Regulatory environments. Established and led the U.S. based Pharmaceutical Sciences group for 14 years. Awarded 6 patents. Founded the Discovery/Development Interface Group as a predecessor to the Research-Early Development process intended to expedite First in Human evaluation of new molecular entities. Conceived, created, and led the Regulatory Sciences function within the Global Regulatory Affairs, Chemistry Manufacturing and Control (CMC RA) organization for 20 years. Provided guidance to Development Teams and their senior leadership on issues of scientific and regulatory importance impacting characterization/control of products and processes across portfolio life cycle. Coordinated all Due Diligence support provided by CMC RA in assessing value and risk of potential in-licensed products and company acquisitions. Served as an active member of the PhRMA Global Quality and Manufacturing Committee, China Working Group, and Technical Leadership Committee. Created the Users Network Group as a member of the IPEC-Americas Executive Committee. As inaugural member of ISPE Product Quality Lifecycle Implementation (PQLI) initiative, co-chaired the Criticality topic. Represented Johnson & Johnson on a variety of Product Quality Research Institute (PQRI) Working Groups. Interacted with global regulatory authorities to strategically influence the future policy landscape with primary focus on US and Asia Pacific region. Serving as an Adjunct Professor, Temple University – Department of Graduate Studies within the School of Pharmacy since 2003. Founded TRxS Consulting LLC following retirement from Johnson & Johnson in 2022 as a service to provide technical and CMC regulatory advice/training based on existing and evolving scientific/risk-based principles.