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Polymer Consultant Expert in Softgel Capsule Technology and Paint Ball Formulation and ManufacturingSoftgel capsule technology for pharmaceuticals and recreational products.Chemical research related to medical polymers, analytical methods and personal care and cosmetic product formulation.Formulation of paintball fills, shells and colors.Paintball manufacturing technology.Independent Consultant, 2000 - PresentPolymer processing and paintball manufacturing technology.R. P. Scherer, Clearwater, FL, Technical Service Scientist, 1993 - 2000Devel...
Seasoned pharmacists with years of experience in drug development, drug delivery, controlled release and statistical quality assurance of production.Expert in managing drug product development of new chemical entities, novel drug delivery systems (film coated tablets, chewable tablets, rapidly disintegrating tablets, effervescent tablets, controlled release tablets, liquids, suspensions, parenterals, etc.). Highly experienced in formulation development, quality assurance, PAIs, and authoring NDA/CMC documents.Thoroughly familiar with GMP, GLP, and FDA expectations.Pharmaceutical Product R&DDrug DeliveryStatistical Optimization of Pharmace...
Expert chemist consults on biodegradable polymer formulations and microencapsulation, applicable to biocides, fungicides, herbicides, also consults on leather chemistryBiodegradable Polysuccimimide and PolyaspartatesIsothiazolone Biocide FormulationsMicroencapsulation for a broad range of application areas - biocides, fungicides, herbicides, coating cross-linkers, fragrancesAcrylic dispersionsLeather Chemistry, including curing, tanning, coatings and analysisBiodegradable polymers based on aspartic acid chemistry, including manufacturing, synthesis, analysis, derivatization, and application studies based on aspartic acid chemistry.
Expert consultant for MEMS microfluidics, analyses and manufacturing processesMicroelectromechanical systems, MEMSMEMS microfluidics and MEMS manufacturing processStandard and specialized machining and fabrication processes for MEMSMEMS instrument design and microarrays"LabView and Data Acquisition SystemReverse engineeringSensors and portable instrumentsIR-JKR SpectroscopyProject Scientist, University of California, Irvine, Irvine, CADesign MEMS manufacturing processes for biomedical and space satellite equipment. Clean room fabrication of MEMS components.Postdo...
Over 15 years experience in pharmaceutical manufacturing of solid dose, liquid/semi - solids, and transdermal products.Expert in solid oral, liquids and transdermal pharmaceutical dosage forms.15 years of pharmaceutical Quality Assurance, research and development and commercial manufacturing experience.Process expertise in development and manufacture of solids, liquid and transdermal dosage forms.Supply chain experience in warehouse and distribution operations, including design and operation of Automated Storage and Retrieval Systems (AS/RS).Technical expertise in qualification of equipment, utilities and facilities, cleaning and process v...
Neurobiologist Consultant: Central Nervous System, Spinal Cord Injury, Hemostasis, Thrombosis and Autoimmune DiseasesEight (8) years of experience in biotherapeutic drug discovery and development with a focus on neurobiology, hemostasis, thrombosis and autoimmune diseases.Drug discovery research for hemophilia and in critical bleeding indications.Development of therapeutics for spinal cord injury, multiple sclerosis and other central nervous system disorders.Experienced with molecular and cellular pharmacology, cell-based assays with central nervous system (CNS) and immune cell types, immunohistochemistry and thrombosis pathology, animal m...
Expert in Drug Stability, Drug Chemistry, Drug Development Test Method Development, Data Management, Outsourcing, Technical Training and Regulatory ComplianceDrug stability: Pharmaceutical analysis and validation and transfer.Technical knowledge across multiple disciplines of drug development.In depth knowledge of drug stability, cGMP/GLP and method development and validation.Experience with current FDA regulations and compliance, ICH, and global requirements, cGMP/GLps, CMC, IND, NDA, sNDA and annual reporting.Experienced addressing commitments related to FDA Consent Decrees.National and international oral presentations on "Stability" an...
Pharmaceutical R & D consultant specializing in strategic and operational planning, safety assessment, toxicity study protocols and re-engineering.Pharmaceutical research and development methodology.Pharmaceutical research and development portfolio strategy and management.Drug development modeling, scenarios and matrices for decision support.Re-engineering and R&D core business systems; R&D budget and resource forecasting.Pharmacoeconomics, health outcomes and disease management.New Chemical Entities (NCE) drug development.Phase I to Phase IV drug pre-clinical and clinical safety assessments.Pharmaceutical IND, NDA and ANDA registrations....
Dosage From Pharmaceutical Consultant: Facilities Management and GMP ComplianceFormulation and process development of multiple types of pharmaceutical dosage forms.Research and development, optimization, manufacturing and packaging of solid, liquid and powdered dosage forms.Scale up and technology transfer of multiple dosage forms.Equipment and processing knowledge, product processing/equipment trouble-shooting and facility validation and qualification activities.Identifying and implementing significant operational cost savings in pharmaceutical operations.Auditing of diverse cGXP operations (API manufacture, laboratory operations, clinica...
Analytical Chemistry Consultant for Size Exclusion Chromatography (SEC)SummarySize Exclusion Chromatography (SEC, also known as Gel Permeation Chromatography, GPC) and its application to the compositional and failure analysis of polymers for pharmaceutical, medical device and the chemical Industry. Specific SEC experience includes:Molecular mass distribution (MMD) of natural and synthetic polymers, blends and oligomers.Analytical method development, validation, transfer, stability studies, quality control, cleanup and release testing procedures.Environmental resistance of polymers, including chemical exposure, oxidative resistance, weathe...