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Process Engineering, Project Management
Expert brings 15+ years of Process Engineering and Project Management experience in the Chemicals/Oil and Gas/Pharmaceutical/Green Hydrogen domain (in the USA and Singapore) and has also worked in manufacturing and the EPC environment. Expert has led multiple projects concurrently throughout…
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…
General Industrial Hygiene; Toxicology; Laboratory Safety; Hazard Communication; Chemical Hygiene
Expert has worked as a consulting industrial hygienist for 24 years. He is both a Certified Industrial Hygienist (CIH) and a Certified Safety Professional (CSP). He has conducted many detailed compliance evaluations/inspections and has developed helpful code interpretations for clients.…
Medical Device & Pharmaceutical Quality Systems; Regulatory. Affairs; Quality Fitness Reviews
Advised and trained Operations and QA employees in a large pharmaceutical plant on effective practices to investigate and document deviation events on the manufacturing floor and quality control laboratory. The aim of such investigations was to determine a root cause…
Customer Experience of Digital Transformation, Digital Strategy, eCommerce
Expert has spent the last 24+ years delivering award-winning omni-channel Customer Experience (CX) and thought leadership in digital transformation, retail (e-commerce), intelligent enterprise, and design thinking. Expert is a digital vision and strategy executive who translates consumer (CX) and employee…
Medical Excellence- Management (Preauthorization/ Reimbursement)
An astute and skilled professional with over 7 years of experience in the field of healthcare operations. - Currently serving as Medical Excellence Manager; qualified MBBS, Lean Six Sigma Black Belt from Michigan institute and Gold Medalist in MSc Healthcare…
Formulation Chemistry
Spray drying expertise in volatile solvents and end-user food powder products. A lead formulation chemist with over eight years of experience in the area of the formulation. A talented chemist that excels in a high-performing multidisciplinary research environment in the…
Infusion Nursing
Energetic, self-directed clinical educator with 25 years’ experience in infusion and oncology therapy in the home, clinic, and hospital setting. Expertise in all aspects of home infusion, standards of care, and evidence-based practice to promote clinical excellence and positive outcomes…
Bioanalytics, Chemistry
As an active contributor in the R&D scientific division of both industry and government for the past 20+ years, Expert has had the opportunity to leverage his strong structure elucidation background from graduate school for application in clinical, and forensic…
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…