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Analytical Chemistry: HPLC, LC-MS, Bioanalysis. R&D projectmanagement; writing of publications
Expert’s scientific expertise includes the development, optimization and validation of quantitative bioanalytical methods for small molecules, peptides and biopharmaceutical drugs as well as for their metabolites in biological fluids (plasma, urine, tissue, etc.). These methods are essential for the pharma…
Managing the Interface Between Owners and Engineering Contractors
Expert has successfully directed engineering and construction projects with values up to $700 million, primarily in the U.S. Working directly for the Owner, he most recently completed a $200 million project, 5% under budget and 2 months ahead of schedule,…
Pharmaceutical Quality Assurance, Quality Control, Supplier Selection and Supplier Quality
Expert has extensive expertise in GMP matters in the pharmaceutical and medical device industries. During his 20 years in industry, he devised, managed and led programs to assure compliance to drug GMPs, GLPs and GCPs. Key areas of expertise included…
FDA, FTC, regulatory, fraud and abuse, e-discovery, OTC, pharma, sunshine act, social media
Expert currently serves as Regulatory Counsel for Allergan, providing proactive legal support to senior management, product brand teams, and client groups across organization, advising and educating on regulations pertaining to pharmaceutical products. He serves on multiple brand advertising and promotional…
Rheology, Nanotechnology, Particulate/Multiphase Processes, Chemical Engineering.
Expert operates his contract research & development small business incorporated in 1990 in Saint Paul, Minnesota, USA. Expert's professional experience spanning over four decades in chemical engineering has focused around the broad areas of particulate/multiphase processes and rheology. Chemical engineering…
Preventive Medicine, Epidemiology, Pharmaceutical and Biotechnology Industry
Expert received his M.D. degree from Baylor College of Medicine in 1982 and completed his resident training in general surgery at Baylor affiliated hospitals in 1985. His training includes postgraduate and/or postdoctoral experience in general surgery, epidemiology, and preventive medicine…
Product Development, Quality Assurance, GMP Audits, Qualifications, Troubleshooting, Pharmaceutical, Nutraceutical, Production Issues, GMP Compliance, Pharmaceutical Dosage Forms, Quality Control
Expert has more than 24 years of experience Internationally (New Zealand; Australia; Oman, and India) in pharmaceutical formulation plants, Product Development; Analytical development; Scale-up, Technology transfer; Manufacturing, Quality Assurance; quality control (testing and releasing); Lead regulatory audits and meet the…
Polymer Chemistry, Thermoset Polyimides, Epoxies, Cyanate Esters, BMIs, Ultrahigh Temp Polymers
He has worked on high-temperature resistant aromatic and heteroaromatic polymers, including thermoset polyimides, BMIs, cyanate esters, and other high-temprature polymers. He has designed a series of high-temperature poly(arylene ethers) for the semiconductor manufacturers to be used as interlayer low-k dielectric…
Industrial Hygiene, Non-Friable Asbestos-Containing Materials, Formaldehyde, Silica, Indoor Air Quality, Mold, Accident Investigation, Auditing and Hazard Assessment
He has conducted numerous indoor air quality and environmental mold assessments for commercial and residential environments. Assessment includes monitoring for applicable indoor air consituents, developing corrective action plans, and verification of correction/efficacy. He also lead the indoor air quality committee…
Due Diligence, Competitive Differentiation, Science Scouting, Innovation Assessment, Research Tools, Expert Witness, Cancer Biomarkers, Cancer Immunology, Assay Development, Research Devices
Developed multiple novel immunoassays and immunology products for start-up biotechnology company. Founding Director, Research and Development for privately held company in San Diego. Oversaw innovation and entrepreneurship at Mitchell Cancer Institute resulting in 5 spin-out biotechnology companies in the area…