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Operational Excellence & Six Sigma Black Belt
Expert is a Six Sigma Black Belt with over 20 years of experience building infrastructures to achieve operational excellence. He has experience with ERP systems implementation, leadership, strategic planning and organizational development with operational and technical skills. His track record…
Biotechnology, Nucleic Acids, DNA and RNA, and Research and Drug Development
Subject matter expert on biotechnology and nucleic acids with over 20 years of experience. He is an experienced developer of tools for the detection and quantification of both DNA and RNA for diagnostics, and research and drug development. Expert currently…
Green and Clean Energy: Petrochemical, Refining, and Downstream Chemical and Utilities Sectors: Pre-commissioning, Commissioning, and Plant Startup
Executive summary: Expert has 17 years' experience in the petrochemical, refining, and downstream chemical and utilities sector. His experience includes pre-commissioning, commissioning, plant routine startup, shutdown, and emergency operations. His management roles include service as process trainer and process commissioning…
Pharmaceutical Development
Expert is a former FDA Review Chemist, with > 39 years of career experience in pharmaceutical R&D, Quality Operations and Regulatory Affairs. For 25+ years as a consultant in his own pharmaceutical development advisory firm, Expert has furnished clients with…
Laboratory Management and Development: ISO and Internal Audits, Statistical Process Control, Sampling and Process Improvement
LABORATORY MANAGEMENT AND DEVELOPMENT: Expert managed and developed an analytical laboratory from department side service for basic soil analysis to independent profitable Laboratory unit for soil, plant and water analysis. The laboratory supported research and also performed testing services for…
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…
Hospital Tests and Kits, Clinical Chemistry, Coagulation, Serum Controls, Manufacturing Processes
Expert received his PhD in Biochemistry (Enzyme kinetics on NAD kinase in 1981), where he proposed a mechanism, Rapid Equilibrium Random with two dead end complexes for the enzyme, using enzyme inhibition studies. He was able to apply this knowledge…
Diagnostic Reagents Formulations & Trouble shooting; Disinfectants and Hand Sanitizers; Stains
Mr . Expert has aquired efiiciancy in the field of formulating various clinical chemistry analytical kits. He had more than 5 yrs of experience in designing and setting various products manufacturing units with complete transfer of technology. He is post…
Clinical Diagnostics, Immunoassay Product Development, Clinical Toxicology
Expert has two major areas of Expertise: 1) He has been involved in all aspects of In Vitro Diagnostic Immunoasasy and Clinical Chemistry Product Development Including Laboratory Research and Development, Transfer to Manufacturing, Documentation to meet QSR including Design History,…
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: •…