Currently Chief Technology Officer Porton Pharmatech/J-Star Research, Inc.
SME in continuous processing API, continuous processing DP, particle engineering, pharmaceutical composite material, co-processing and pharmaceutical process scale up in both API and DP. Research Professor at Rutgers University Department of Chemical Engineering. Research projects on continuous manufacturing and material science related to pharmaceuticals. Championed work flow in pharmaceutics development that eliminates DS/DP boundary. Thirty five years of pharmaceutical development and technology transfer experience in Bristol-Myers Squibb covering both Active Pharmaceutical Ingredient (API) and Drug Product (DP) areas. Expertise in crystallization, particle engineering, reaction engineering, continuous processing (both DP and API), pharmaceutical composite material (PCM) and co-processing. PCM is a relatively new technology in which API and excipients are combined under controlled conditions to produce a composite material with unique properties that can be used to address some common issues in formulation development, such as content uniformity, stability, powder flow, taste, drug release profile, bioavailability, and material handling containment requirements.
PhD chemical engineer with experience in directing multi-disciplinary teams in the scale-up of pharmaceutical, chemical and biochemical processes from development to manufacturing. Participated in 11 NDA projects that were eventually commercialized. Successfully participated in QbD filing with the inclusion of risk assessment and process modeling to emphasize fundamental approach to process design. Focus on problem-solving through mechanistic understanding. Results and execution oriented manager. Comprehensive knowledge of cGMP, advanced development techniques, strategic sourcing, plant facilities and issues at the API-DP interface. Pioneer in pharmaceutical engineering and the application of PAT. Recognized expert in crystallization and particle engineering issues. Maintains extensive network with FDA, universities, research centers and technology consortia.