Highly motivated and accountable Executive with 2 decades of experience working on cross-functional projects and developing cell and gene therapy products with proven success in decision making, problem solving, troubleshooting and managing staff. ACCOMPLISHMENTS & EXPERIENCE:Provided strategic and technical CMC consultation for over 70 US and international cell and gene therapy clients ranging from academic virtual entities and small private biotech companies to large public biotech and pharmaceutical organizations.Led multiple process development and manufacturing functions at 3 different cell and gene therapy companies.Technical expert in both autologous and allogeneic cell therapy manufacturing process including for genetically modified cell therapy products (i.e. CAR-T cell technology).Deep knowledge of both Lentiviral and Adeno-Associated Viral (AAV) Vector technology, process unit operations and analytical test methods.Authored CMC sections and several CMC amendments in support of 20 different corporate sponsored FDA approved INDs for cell and gene therapy drug products.Led Lean Six Sigma time and motion studies to facilitate design and build-out of laboratory and office space for 4 biotech companies.Developed automated JMP® software based trend analysis systems for 4 companies which were used to monitor pilot and cGMP manufacturing processes and generated monthly reports to senior management.