Consultant Bios
« Previous EntriesIVD Research Director
Wednesday, March 10th, 2010Most recently he was Scientific R&D Director at Genzyme Diagnostics in San Diego, CA. He was responsible for the development of Influenza and other respiratory virus rapid tests, established a cell and viral culture laboratory and was instrumental in introducing automation for the development and manufacture of lateral flow tests. Additional experience includes the instrument [...]
Biotech and IVD Operations Executive
Wednesday, March 10th, 2010Over 25 years experience building, managing, and improving manufacturing, quality, and supply chain systems and processes in innovative IVD and RUO diagnostics companies. Skilled in new product development processes, technology transfer, commercialization and scale-up. Expertise in identifying and eliminating defects and waste in pursuit of world-class cost, quality, and service. Hands-on problem solver, leader and [...]
Assay Development and Project Management Professional
Tuesday, March 2nd, 2010Over 18 years of research and product development experience in the diagnostics industries. Most recently he was Scientific R&D Director at Genzyme Diagnostics in San Diego, CA. He was responsible for the development of Influenza and other respiratory virus rapid tests, established a cell and viral culture laboratory and was instrumental in introducing automation for [...]
Quality and Management Professional
Wednesday, September 16th, 2009Quality and Management Professional with over 20 years in the Medical Device/Diagnostic industry. Experience has been gained from starting in the Medical diagnostic business as a Project Engineer for Abbott Laboratories before moving in Quality and R&D Management in the early 1990’s. He has held many positions within both major international and start up companies [...]
Regulatory Affairs Professional
Wednesday, September 16th, 2009RAC certified in both United States and European Union regulatory affairs by the Regulatory Affairs Professionals Society, of which he has been a member since 1997. Over 20 years’ experience in the medical devices and diagnostics industries in various roles, including product development, manufacturing, quality and regulatory affairs, augmented by over 9 years of direct [...]
Quality Systems Expert
Wednesday, September 16th, 2009Areas of speciality include gap analysis, process mapping, establishment of documentation systems, training, quality planning and implementation of ISO 9001:2000, ISO 9001:2008, ISO 13485 and 21CFR820 QSR, internal auditing, practical corrective & preventive action guidance and vendor assessments. Certified lead auditor and ASQ member.
Market Analyst
Wednesday, September 16th, 2009This consultant has been involved in the health care industry since 1971. She has worked as a laboratory technologist, a marketing services manager for a diagnostics company, and a freelance journalist and editor for medical trade journals. She currently owns and operates her own company that provides market information services to the diagnostics and medical [...]
Marketing and Sales Professional
Wednesday, September 16th, 2009Over 25 years’ experience in the medical diagnostics field, at Vice President and Director level of major medical diagnostic companies. Areas of specialization include Business Development/Sales/Marketing, Licensing, International and Domestic Distribution, Market Intelligence and General Corporate Affairs
Corporate Strategy, Technology Assessment, Gap Analysis & High Level Quality System
Wednesday, September 16th, 2009Strategic and board level market and technology advice based on 20 year’s experience at high levels within industry leaders including Quidel, Inverness Medical Innovations and Response Biomedical Quality, regulatory compliance and operations professional with experience in designing, implementing, assessing and improving product and process life cycle systems, augmenting product development, quality and regulatory compliance, post-market [...]
Bioengineer with more than 10 years Experience in Microfluidics and Bioinstrumentation
Wednesday, September 16th, 2009Overall he has worked on microfluidic and bioinstrumentation for 10 years and has numerous patent applications covering his work. Highly skilled in designing and developing reconfigurable and reusable component architectures that can be assembled into programmable applications to drive complex fluidic functions. Relevant experience includes Director and Senior Scientist level positions at companies including Akonni [...]
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