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Medical or Pharmaceutical R&D and Manufacturing – New Product Approval and Launch Including FDA, EMA, and Asia
40 years in design, manufacturing, R&D, and compliance. For the last twenty years have directed and led projects leading to over thirty 510(k), PMA, and NDA approvals in drug delivery, ophthomalogy, dental, cosmetics, emergency medicine, obstetrics, oncology, and diabetes. Clients…
Product Development and Regulatory Approval of In-Vitro Diagnostics and Companion Diagnostics
PhD in Biochemistry, MBA in Business and RAC (US) Certification with 15 years of experience in diagnostic assay and system development at top global in-vitro diagnostic (IVD) companies including Roche, Bio-Rad Labs, Siemens Healthcare Diagnostics and Employer. A proven track…
Pharmaceutical Manufacturing & Packaging: Sterile Pharmaceuticals, Blow Fill Seal, Liquid Filling, Solids Filling, Facilities & Equipment
Pharmaceutical Industry Expert with over 35 years of experience in all aspects of pharma manufacturing and packaging. He is a leader in manufacturing facilities and equipment, with in-depth knowledge of design, construction, start-up, validation, operations, and maintenance. He is an…
Medical Device and Product Development Expert
Expert is a seasoned Engineering Leader with over 20 years of experience in Medical Devices, including Product Development and Product Management. He set up the Global Technology Centre for TE Connectivity and Medtronic in India and has established a Catheter…
Utility-Scale Energy Storage, Solar Operations, Renewable Energy, Grid-Scale Battery Storage Systems
Operations and Engineering professional in the renewable energy sector, specializing in energy storage and solar technical operations. Expert is a U.S. Military veteran with expertise in technical asset performance in the energy sector. Expert is familiar with The Electric Reliability…
Building Products and Glass Innovation
Experienced business leader and entrepreneur with a successful track record of generating profitable, sustainable growth through material science innovation. Core strength is building teams to scale new product innovation technologies and applications that leverage true competitive advantage improving bottom line…
Operations, Manufacturing, and Supply Chain
Expert is an experienced operations, manufacturing, and supply chain leader. Summary: Former Engagement Manager at McKinsey and Company -- with over 9 years' industry experience Post-McKinsey. Interests: Consulting, Private Equity, Operations, Manufacturing, Supply Chain, Food, and Consumer Goods. Expertise: Manufacturing…
Financial Risk Management, Risk, Governance, Regulatory Change Management, Financial Services, and Financial Literacy Coaching and Teaching
A financial services executive, Expert specializes in the development and implementation of enterprise risk management and governance frameworks. She advises companies on aligning mission and strategy with operating models and controls. She also troubleshoots and remediates operational and regulatory issues.…
Fermentation, Scientific and Regulatory Affairs
Expert is dedicated to commercializing novel ingredients for health and sustainability Proficient in human pathology, plant biology, synthetic biology, and fermentation technology. Her specialties include Product Innovation and Formulation, CPG Application Testing COGS and Process Improvement, Food Science, Safety and…
Digital Solutions, Mobility, AI, Autonomous Driving, Industrial IoT
Outstanding innovation expert with broad knowledge of Digitalization, Artificial Intelligence, Industrial IoT and Smart Mobility. He combines in-depth technical expertise with strategic vision, and blends key technologies and concepts from a variety of disciplines to develop new, innovative and sustainable…