Biotechnology executive and subject matter expert in technical operations and clinical development of cell and gene therapy (CGT) products with over three decades of work in multiple small startups as well as established pharmaceutical companies. Extensive expertise in process development, project management, biologics manufacturing, analytical development and product development, building highly effective teams across industrial, academic and clinical institutions.Key Strengths Include:TEAM LEADERSHIP• Organized and led cross functional team to rapidly build internal manufacturing capability for supplying our clinical trial after identifying deficiencies in an external contract partner affecting our timeline. The team designed and constructed a pilot manufacturing facility within six months and built an internal production group that made the clinical trial possible.PRODUCT DEVLOPMENT, OPTIMIZATION AND TESTING • Created a development strategy for prioritization, cost control and manufacturing of a new product creating a road map identifying critical decision points, available resources and investment options at different stages of clinical testing and commercialization, enabling a disciplined approach to prioritize investment and preserve capital in the initial stages of testing.PRODUCT SUBJECT MATTER EXPERT (SME) • The company required specialized expertise to register a new type of medicinal product with the regulatory agency (FDA) to begin clinical testing. Leveraged my knowledge of similar products, to complete the CMC section of the IND and negotiated with the FDA about details of the manufacturing process, resulting in the approval of manufacturing process design and allowing the company to test its first product in the clinic.EXTERNAL PARTNER MANAGEMENT • Collaborated with the Primary Investigator Partner on gaining critical information and data required to define manufacturing processes and final product testing requirements for technical transfer. Provided guidance for process startup including batch record review, cGMP standards, risk management and regulatory insight resulting in successful execution and providing the IND enabling data required to begin the clinical trial.INVESTOR RELATIONS & COMMUNICATION • Served as the point person answering inquiries from potential investors, in writing and in person, on regulatory filings providing needed technical insight during due diligence discussions which provided the required assurance to the investors that the FDA accepted our proposals, and our team was technically capable.