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Toxicologist, Dietary Supplement and Functional Food compliance
Experienced toxicologist with knowledge of product formulations, regulatory requirements, and analytical evaluation of test results. Worked as a toxicologist for NSF International for 15 years in dietary supplements and functional foods. Have been self-driven and working from home for the…
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.…
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…
Coatings; Powder, liquid, Electrocoating and metal finishing process
As a Continue Improvement Manager (holding a Managerial position company deems fit), Expert is offering his engineering education, managerial experience, training in Lean manufacturing principles and Kaizen facilitation expertise to Operations, Business Unit or Production Area at a Manufacturing, Pharmaceutical,…
Pharmaceutics
Expert is a process and chemical engineer with a Bachelor from Univercity Laval in Quebec City. He has more than 15 years experience in engineering, automation, validation of manufacturing equipments, clean utilities, pharmaceutical systems and computer systems (cGMP, GAMP5, CFR-21…
Industrial, Power and other Water Treatment, Root Cause of Operational Failures, Treatment Design and Optimization
Expert has served as a water treatment service representative, a manager and a consultant for more that 30 years. He has a thorough approach to system treatment which is data driven and knowledge based. Root causes and combined contributing causes…
Pharmaceutical Formulation
Expert received his M.S. and doctorate in Pharmaceutical science from Long Island University, Brooklyn campus in 2017. During his doctoral dissertation, he worked on the rheological characterization of transdermal formulation and application of rheological models in product development and scale-up…
Pharmaceuticals, Drug Delivery, OTC, and Rx products
Expert actively consults in nearly all routes of drug delivery, including oral, transdermal, topical, inhalation, injection/infusion, nasal, buccal and others. He holds a Ph.D in Polymer Science and Engineering, as well as an MS on the same topic. He holds…
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 Manufacturing, Combination Products, Medical Devices, and Good Clinical Practices
Expert is a retired Public Health Service (PHS) Officer with 16 years of FDA experience in Pharmaceuticals, Medical Devices, Biologics, and Bioresearch Monitoring. She has held the positions of Investigator, Pre-Approval Manager, Supervisory Investigator, and Foreign Inspection Cadre Member. She…