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Medical Device Regulatory Affairs, Quality Assurance, FDA 820 EU ISO 13485 510(k) & Medical Software
Lead and developed regulatory plan and strategy for Molecular Diagnostic System. Blood Analyzer, Gene Profiling Reagents, Blood Analyzer etc. Assembled with team regulatory submission and obtained 510(k) clearance, EU CE Mark, Health Canada, China SFDA, Mexico, Australia, South Korea, and…
Gas Separations Membranes, CO2 Capture, Hydrogen, Industrial Gases, Renewable Energy, Algae
Expert is a former Praxair Corporate Fellow with over 60 patents and 30 years of broad industrial experience in developing and commercializing new technologies. He is a recognized technical expert in separations with extensive business development experience. At Praxair he…
Real-Time Embedded Control Software
Experience and expertise is in real-time embedded software and its development, IP, training and support. Having experience working with small to mid-sized companies in communications, automation, consumer electronics and automotive industries, Expert has participated in many facets of business, obtaining…
Metabolomics, Mass Spectrometry and Plant Pathology
Expert has developed expertise in metabolic reprogramming during susceptible and resistant interactions of Magnaporthe grisea with host plants, Brachypodium distachyon and rice as well as abiotic stress resistance in plants such as drought or cold tolerance. Such systems present many…
Life Science, Biotech, Pharmaceuticals: Research and Development, Smart Manufacturing/ Supply Chain, and Market Launch/ Commercialization
Expert has over 20 years of experience in strategic innovation, system building, and delivering value solutions for global markets. His focus is on building infrastructure synergies between science, technology, and finance. As a Strategic Advisor, he has experience with: •…
Near Infrared Spectroscopy, Multivariate Analysis, Pharmaceutical Analysis, (GMP)
Expert is an internationally recognized expert in pharmaceutical analysis, regulatory compliance, laboratory management, design quality, and process analytical technology using spectroscopic methods, including near-infrared and multivariate analysis. Nineteen years of industry experience with increasing responsibility and five years of policy…
Process Plant Design and De-bottlenecking, Gas Phase Polymerization and Material Handling
Expert has two decades of process plant expertise with significant proficiency developed in polyethylene and polypropylene technology, process evaluation and plant design. Expert has applied his process engineering knowledge to improvements, optimization, trouble-shooting and projects in chemical and petrochemical plant…
Drug Development (Small Molecules, Peptides, Biologics, Parenteral Nanoparticles); Drug Delivery
Expert is an expert in analytical instrumentation and analytical methods development and validation, especially for drug regulatory filings with the FDA and EMEA according to all FDA and ICH guidelines. He established a state-of-art core instrument department at Altus Pharmaceuticals…
Chemical and Pharmaceutical Development – Comprehensive CMC
Expert has worked on research, development and manufacturing problems involving stereochemistry throughout his academic training and industrial career. Relevant examples include: development of scalable chiral and asymmetric syntheses; improvement of reaction stereoselectivity; tracking of chiral integrity in chemical processes; chiral…
Phased Array Radar Systems, Antenna, Microwave, Guidance and Control Systems
Expert has more than 20 years with defense industry (Lockheed Martin, and Raytheon). He is a Radar System Expert and Analyst of Radar System performance and Phased Array Radar Systems for more than 15 years (recently designed EQ-36 mortar radar,…