Experienced Research And Development Manager with a demonstrated history of working in the pharmaceuticals industry. Skilled in Good Laboratory Practice (cGLP), Good Manufacturing Practices (cGMP), U.S. Food and Drug Administration (FDA), ICH, Analytical Chemistry, and Technology Transfer. Strong research professional with a Master of Business Administration (MBA) from University of Utah. Lead R&D projects in support of product development, scale up, and ANDA filings. Oversight of product, analytical, formulation, validation, and scale up development. Responsible for activities at contract testing labs in support of method establishment. Manage GMP batch release, stability, and additional studies to support ANDA regulatory filings. Oversight and management of contract development and manufacturing organizations supporting development and scale up for parenteral and OSD products.
Listed skills include Gmp, Glp, Technology Transfer, Analytical Chemistry, and 11 others.