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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…
Product Development, Project Management, Strategic Growth
• Chemistry professional (Ph. D Chemistry) with business administration education (MBA) having international academic teaching and research, and industrial work experience involving product development, project and people management, and financial administration. • Accomplished results-driven innovation leader with a track record…
Engineering, Construction, and Standard of Care
Expert has 25 years of engineering experience working on regional, national and global projects including the design, engineering, construction and commissioning of numerous residential, commercial and industrial facilities. He has provided subject matter expertise in engineering, engineering management, facility design…
Pharmaceutical Science; Preformulating, Development, Chemistry, Manufacturing & Control (CMC) Issues; Paragraph IV Hatch-Waxman & Canadian Notice of Allegation
As the development of a pharmaceutical reaches Phase 3, prior to submission of an NDA, method validation is required. Validation is a demonstration of optimization. By demonstrating the capacity of a method within the bounds of validation, optimal conditions for…
Medical Device Quality Assurance and Regulatory Compliance
Expert is a 34-year food, cosmetic, drug, biologic, clinical, medical device, and combination product non-technical quality assurance and regulatory compliance veteran with over 21 years of FDA/ governmental experience as an analyst and level II certified international medical device investigator…
Cosmetic Manufacturing
• Successfully Handled a new range of Ayurvedic Manufacturing Factory from the scratch. Efficiently Managed a Factory with 400 man power. • Managed Five 3rd party manufacturing plants successfully. • Successfully Handled Flavour & Perfume Blending unit. • Setting up…
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…
Mechanical Engineering
Expert specializes in the analysis of products and systems in the automotive, thermal design, consumer product, and industrial environments. His work includes investigations of technical issues related to vehicles, liquid and gas flows, consumer appliances, and consumer electronics. He has…
Sterile Process Validation, Microbiology, Steam Sterilization, Aseptic Filling, Rapid Micro Methods
Expert has over 25 years experience in various aseptic of sterile process validation. She has worked for Baxter, Fujisawa (now Astellas), Jordan Pharmaceuticals, Vectech Pharmaceutical Consultants and Excellent Pharma Consulting. This encompasses steam sterilization, aseptic filling, process validation, development of…
Global Procurement, Chemical Engineering, Manufacturing, Chemicals, International operations,
With over 17 years of experience managing new product development teams, Expert is currently Vice President of Research and Development. He is responsible for strategy, the new product pipeline, project management, resource allocation, product innovation, and intellectual property. His team…