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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.…
Delivery Systems: Pharmaceutical and Consumer Products
Accomplished chemist with a Ph.D. in Pharmaceutical Chemistry and the proven ability of leading, coordinating and successfully executing the complete project lifecycle from initial idea through to final implementation and closure combined with a strong ability in creating international partnership…
Reaction Engineering, Process Reactor/ Technology Development, Design, Debottlenecking/ Revamp/ Upgrade, Modeling/ Application Software, Process Intensification
He is a recognized expert in design, development, scale-up, demonstration and debottlenecking of commercial reactors. With a track record of successful commercialization of three new technologies, currently working for a fourth, and zero-failure, he offers a unique set of capabilities…
Unsaturated Polyester Resins, Polyester Gel Coat, and Composites
Expert has 40 years of experience with international companies producing gel coats and resins. He has been involved in formulation, manufacturing, control, application and subject matter consulting for end products and problems. He has served as a manager in the…
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…
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…
Medicated Aerosol and Inhalers
Expert has been in the field of Medicated aerosol (MDI, DPI and nebulizers) since 2004. His PhD was in this field and most of his 77 published paper and 48 conferences presentations are in this field. Expert has a respiratory…
Pharmaceutical Formulation (Tablets, Capsules, Semi-solids, Liquids), QbD, and CMC Regulatory/Risk Assessment Issues
Expert is a Pharmaceutical Formulation Scientist with 25+ years' industry/FDA experience developing and commercializing tablets (fast dissolving, effervescent, chewable, coated), capsules, ODT's, coated beads (i.e., controlled release and taste-masked), topicals (liquids and semi-solids), & CBD/hemp products. He also has experience…
Pharmaceutical Formulation, Process Development and Manufacturing of Products Focusing on Poorly Water Soluble Drugs
Extensive experience in formulation design and manufacturing process development and optimization gained working for large, medium and smaller companies.Having worked on the development of a relatively large number of small molecules at all stages of development, Expert has gained specialist…
Pharmaceutical Development
Expert has over 28 years experience as a pharmaceutical executive managing various aspects of drug product development, including outsourced pharmaceutical manufacturing and broad aspects of the CDMO industry. Previously, Expert was the President of Pharmaceutical Development Services and the Chief…