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Expert ID: 734985 California, USA

Expert in Instrument Design and Development; Medical Devices, In-vitro Diagnostic Instruments; Clinical Laboratory Automation; Project Management; Planning, Scheduling, Budgeting. QSR and Design Control

Expert possesses a 30-plus-year track record managing medical device and in-vitro diagnostics development from concept to successful market introduction. A proven manager, he has accrued significant skills in leading diverse and multi-organizational teams in the successful development of leading edge,…

Expert ID: 723693 Florida, USA

Expert in Pharmaceutical Science; Preformulation, 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…

Expert ID: 736031 India

Expert in Formulation Development of Cosmetic Products

Science- Based Formulation Development Expertise for Cosmetic (Skin and Hair care) products. Set up a product development centre for a Skin care Startup. Previous experience includes: Applied Research Head for Loreal, Japan; Head of Personal Care R&D, Himalaya Wellness and…

Expert ID: 732325 Minnesota, USA

Expert in Medical Devices, Business Development, Regulatory Affairs, Project Management

Expert successfully launched over 25 new instrument and disposable medical devices. He developed and managed numerous cross-functional and cross-cultural new product and process teams. He has developed rich experience in team leadership and assembly, grounded in RA/QA fundamentals (RAC Certified).…

Expert ID: 735397 Connecticut, USA

Expert in Pharmaceutical Development

He brings 39 career-years’ experience, including service at FDA as a Review Chemist. He began his career in pharmaceutical research and development with Purdue Pharma (Stamford, CT – MS-Contin®, Uniphyl®, Oxycontin®)(3 years), and continued on to Bayer (West Haven, CT…

Expert ID: 735143 Arizona, USA

Expert in Semiconductor Packaging, SMT, Flip Chip and WLCSP Assembly, Failure Analysis, Advanced Packaging Substrates, Printed Circuit Boards, Product Development

Advanced Semiconductor Packaging, Expert Witness & Technology Due Diligence, Technology Investment Advising Dynamic Senior Engineering Manager with more than 15 years of International Semiconductor Packaging development and high-volume manufacturing of advanced IC packages for mobile, automotive and medical end applications.…

Expert ID: 735168 Colorado, USA

Expert in Biopharmaceutical Process and Product Development; Patents and Trade Secrets in the Biotechnology Industry; and Biosimilar Patent Infringement

Expert is a classically trained biochemist with 30 years of experience in the biopharmaceutical industry as both a hands-on scientist and scientific leader in process, analytical, and formulation development, product commercialization, and product quality assessment. During his long tenures at…

Expert ID: 734608 Texas, USA

Expert in Human Resources and Business Development

Expert has over 20 years of functional and consulting experience across several industries and spanning all stages of the business life-cycle. She has accrued extensive hands-on experience leading all phases of HR initiatives including recruiting, policy design, training, workforce development,…

Expert ID: 733788 North Carolina, USA

Expert in IVD Assays and Diagnostic Tests Development

Expert's areas of expertise include the following: IVD (in vitro diagnostics) clinical laboratory regulation molecular diagnostics blood assay diagnostic instrumentation assay development CLIA-88 (Clinical Laboratory Improvement Amendments of 1988) clinical laboratory regulation quantitative risk analysis (risk assessment) laboratory management GLP…

Expert ID: 733329 California, USA

Expert in 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…

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