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Laboratory Management and Development: ISO and Internal Audits, Statistical Process Control, Sampling and Process Improvement
LABORATORY MANAGEMENT AND DEVELOPMENT: Expert managed and developed an analytical laboratory from department side service for basic soil analysis to independent profitable Laboratory unit for soil, plant and water analysis. The laboratory supported research and also performed testing services for…
Environmental and Spatial Statistics, Especially Site Assessment and Remediation
Expert is a statistician with many years of experience in environmental statistics, especially related to site characterization and remediation. He has developed numerous environmental sampling designs for field projects and experimental designs for studies and has analyzed and reported the…
Polymer Chemistry and Organic Chemistry
Expert has over 35 years' career experience in industry. Throughout his career, he was involved almost exclusively with polymer chemistry, spanning a wide range of experiences conducting fundamental research and within various businesses. He has demonstrated the ability to lead…
Diving Accident Investigation
Bob notes that corrosion is a major problem that affects many industries. Bob has spent over forty years studying and solving corrosion problems in the construction, aerospace, defense, petroleum, utility and related industries. He was also the technical editor of…
BioStatistics, Pharmaceutical Devices, Biotechnology, and FDA and EMA Submissions
Expert holds a Ph.D in Statistics and has 25 years' applicable industry experience. He currently serves as a biostatistical expert witness in high-stakes pharmaceutical and medical device litigations. He has expertise in pre- and non-clinical, Phases I-IV in biostatistics, data…
Lyophilization
Expert's career in the pharmaceutical industry spans over 20 years. His work has focused on the following: • Supervision of pharmaceutical plants and technological transfers. • Development and implementation of operational standard procedures related to manufacturing processes and quality control.…
Organic Chemistry, Biocatalysis, Fermentation, Industrial Biotechnology, Chemical Process Development, Patent Liaison, Expert Witness for Patent Litigation
Expert has over 30 years of experience leading process development groups in a variety of fields. He employs biocatalysis and other biological methods to perform organic synthesis. In his current role, Expert offers executive-level technical strategy, project management, and due…
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…
Industrial Piping Design and Construction
As a consultant, Expert can lend experience-backed technical assistance in cost-effective installations of process piping system assemblies, either by verifying compliance with a design package or by modifying a design package as required to ease constructability and control costs. Expert…
Pharmaceutical Discovery and Preclinical Development
SPECIFIC PRODUCTS IVIG (Gammar-P IV ) Rhone Poulenc Rorer Marketed AMP – 579 Rhone Poulenc Rorer Phase II Fenofibrate (TriCor) Abbott in-licensed from Fournier. Over $1 Billion in annual sales. ABT-538/ABT-378 (Kaletra) Abbott over $1 Billion in peak annual sales…