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Product Development and Manufacturing Technology Transfer in Composite Materials for Industrial, Biotech and Medical Devices
Expert's principal expertise lies in conducting original research, development, and evaluation of alternative process capabilities, in support of new product development. His work has typically led to the establishment of new manufacturing platforms for a variety of material science-oriented businesses…
Disposable Medical Device Manufacturing
Expert has extensive experience in the areas of disposable medical devices. Utilizing his B.S. in Plastics Engineering and 20+ years experience in medical device manufacturing, Expert assists start-ups and Fortune 500 Medical Device OEM's with their medical device manufacturing challenges.…
Biotech, Pharma and Medical Device Product and Process Development, Scale-up & Commercialization
His approach to process validation is that PV begins at the process development phase. A process that is well understood, well defined as per the critical to quality attributes with an understanding of the variable interactions prior to the definition…
Medical Device Product Development; Machine Design; Biomedical Engineering
Medical device product development engineer. He performed research on adding an antimicrobial agent to a silicone rubber medical device molded using LIM. The research included materials, methods of molding, color changes, and effects on biocompatibility. His library contains many materials…
Plastic and Coating Stabilization; Controlled Degradation Analysis and Design; Analytical Services
Expert's knowledge in the area of amorphous and crystalline polymers is based on 36 years in the field, having worked with all commercially available amorphous, crystalline, and semicrystalline resins. His knowledge includes physical properties and stabilization at many levels and…
Business Management, Change Management, International Trade and Licensing, Technology Management
Considering his multi disciplinary education, and diversified experience, coupled with international and cross cultural expertise with futuristic outlook, Expert is eminently suited for international trade, strategic planning, diversification and global growth. He has helped different organizations develop their business -at…
Aseptic Process Design, Airflow Visualization, HACCP, PAI Preparation, Cleaning Validation
Expert has performed validation of aseptic processes including technologies such as blow-fill-seal, high-speed automated liquid and powder filling lines, lyophilization, barrier and isolation technology, and bulk pharmaceutical and biological processes. Expert has developed an airflow visualization procedure to assist the…
Membranes, Filters, Separations, Validation, Extractables, Leachables
Expert was responsible for building a new manufacturing facility for hollow-fiber thin film composite membranes for industrial gas and liquid. He helped design the equipment, created the plant layout, hired staff, and led the trouble-shooting phase. He led the engineering…
Registration of Drugs, Medical Devices, Cosmetics,Borderline Products; Reimbursement, expert witness
Expert has more than 30 years experience in the registration of ethical and OTC pharmaceuticals. He has worked with solid dosage forms, aerosols, sterile injectables, vaccines, topical products, and biotechnology products. He has registered new chemical entities, novel dosage forms,…
Adhesives, Sealants, and Coatings
ADHESIVE MATERIAL; SEALANT; COATING PROCESS. Expert spent 17 years in technical work at Loctite Corp., a leader in specialty adhesives. As Chief Engineer - Europe, he spent seven years in product development, technical service, packaging and dispensing equipment. He has…