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Medical Devices, Combination Products, Biotech, Pharma, R&D, Operations, Manufacturing, and Supply Chain
Experienced global leader of R&D, Technical Operations, and Manufacturing organizations. Industrial focus in Medical Devices, Small Molecule Pharmaceuticals, Biotech, Packaging/Labeling, and Combination Products. Broad functional experience in the fields of Project and Personnel Management, Logistics, Supply Chain, and Finance. Successful…
Business Strategy & Development, Strategic Planning, and Management
Led launch teams to expand into 14 EU countries, generating over $100M in sales. Designed org structure of EU regional hub and managed functional shifts. Established strategic planning function through companywide profitability campaign, recovering $10M. Streamlined sales and operational launch…
Traffic Accident Reconstruction, Motorcycles, All-Terrain Vehicles ATVs/ROVs/UTVs, Industrial Accident Reconstruction, Amusement Ride Accidents, Product Defect and Failure Analyses
Expert has more than 15 years of experience providing forensic engineering services in motor vehicle crash reconstruction to law firms, public defenders and insurance companies; Automotive engineer; worked in the automotive industry for approximately nine years; Board certified Forensic Engineer…
Food Science
Expert is a Food Scientist with extensive and diversified experience in multiple food technologies and product types working for global food companies. He is a recognized expert in commercial product launches, technology implementation, factory optimizations and start-ups, cost reductions, and…
Food Processing, Packaging, Quality, Business Development, Cost Reduction, Warehousing and Material
Expert is a Food Processing and Packaging Consultant with active membership in the IOPP Packaging Consultants Council, SPE Consultants Circle, and Food and Beverage Industry Executive Advisory Panel Member. He has over 40 years of product, process, and package development…
Food Labeling; Food, Spring/Bottled Water, Drug and Medical Device Good Manufacturing Practices
Expert was a California Food & Drug Investigator for 26 years enforcing federal GMPs and California health & safety codes. She has traveled throughout California inspecting a wide range of wholesale food, drug, and medical device manufacturers. She was responsible…
Flavors & Fragrances Operations Efficiency, Site Relocation / Consolidation, Quality, MES, Process Engineering
Expert has improved flavors manufacturing, flavors compounding and sample lab best practices across multiple international sites for a top multinational Fragrance and Flavors company. Expert applies this experience to evaluate facilities, develop and justify proposals to optimize and deploy practical…
Food, Confectionery and Pharmafoods Technology
Expert has over 35 years of industrial experience in product development, quality systems, food regulatory, allergen management, contract manufacturing, packaging, product labeling, educational training, food safety and food security. He began his career in food consulting while in graduate school,…
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…
Construction Safety
Expert has over 40 years' experience in worldwide professional safety. His work experience includes tenure as Corporate Safety and Security Director for four Engineering, Design and Construction Management Firms. This work has involved over 600 worldwide construction projects. Additionally, as…