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Medical Device & Pharmaceutical Quality Systems; Regulatory. Affairs; Quality Fitness Reviews
Advised and trained Operations and QA employees in a large pharmaceutical plant on effective practices to investigate and document deviation events on the manufacturing floor and quality control laboratory. The aim of such investigations was to determine a root cause…
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Analytical Chemistry, HPLC, LC/MS, GC/MS, GC/MS/MS, Data analysis, method development, qPCR, Western Blotting
Areas of expertise: LC-MS/MS, GC-MSD/FID/ECD, GC-MS/MS, HPLC, Thermofisher QXactive, ABSCIEX Triple quadrupoles, Agilent Triple quadrupoles, Agilent GC/MS, Shimadzu HPLC/UHPLC systems, Analytical method development and validation for extraction, identification and quantitation of small molecules, Data analysis, Team management and training, Project…
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Pharmaceuticals: Formulations, Injectables, Topicals, Analgesics, Pharmaceutical Analysis
CORE SKILLS Instrumentation skills. APIs/preformulation: X-ray diffraction; Raman spectroscopy; HPLC (potency, degradants, purity, linearity, accuracy, precision, LOQ, LOD) with detection via UV-Vis, fluorescence, and conductivity; content uniformity, dissolution/elution incl. sustained- and immediate release formulations, paddle wheel apparatus; forced degradation incl.…
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Pharmaceutical Development
Expert is a former FDA Review Chemist, with > 39 years of career experience in pharmaceutical R&D, Quality Operations and Regulatory Affairs. For 25+ years as a consultant in his own pharmaceutical development advisory firm, Expert has furnished clients with…
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Material Science and Engineering; Polymer Science
Expert is actively involved in scientific research and the development of new materials and applications in energy storage, including supercapacitors, Li-ion batteries, photovoltaics, thermal storage, and hydrogen storage, as well as rectenna, corrosion plasma cooling, sensors, biosensor, membrane filtration, decontamination,…
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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…
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Microbiology, Biocides, Biotechnology, Renewable Chemicals, Bioremediation
Expert is a microbiologist with expertise in microbiology and biotechnology with 7 years of consulting experience advising large and small industrial clients as well as venture capitalists and investment groups on emerging technologies in areas such as biocides, biofouling, biofilms,…
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Concentrated Apple and Fruit Juice Production & Plant Management, Process Design, R&D
M.S. degree in chemical engineering, 27 years of experience in R&D, process design, quality systems and plant management mainly for concentrated apple and pear juice production, but also grapes and peaches. Responsible for processing more than 1.3 billion tons of…
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Drug Delivery Technologies;Therapeutic Polymers; Biomaterials
Expert is the Principal and Consultant at a consulting company. The company provides advisory and consultancy services in the areas of drug discovery, therapeutic polymers and biomaterials. He has extensive experience in these areas and co-invented eight therapeutic polymers to…
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Biochemistry, Drug Development, Antibiotics, Proteins, Medicines, Pathogens, and Pharmaceuticals
Expert serves on the faculty of a University, Department of Chemistry and Chemical Biology. He previously held a senior scientist and lecturer position at ETH Zurich, Switzerland. His interests are at the interface of chemistry and biology, where he is…