Consultant for Medical Device Validation and Blood Bank Operations and Collection Devices per FDA RegulationMedical device submissions, regulatory affairs related to medical devices and pharmaceutical, good manufacturing practices (GMP) and Quality Systems Regulation (QSR).FDA compliance procedures including process validation, product validation, software validation, warning letters, consent decree resolution, compliance audits, supplier audits and ISO registrations.Extensive and broad knowledge of U.S. FDA quality and regulatory body regulations.Specializing in medical device submissions, regulatory affairs, and Good Manufacturing Prac...

Global Automobile Electronics Expert for Telematics, Auto Entertainment Systems and Electronic Part Manufacturing: General Manager and Engineering Executive Consultant for Automobile Electronic SystemsAutomotive Electronics and Telematics Executive and General Manager.Energy storage focused on lithium-ion storage manufacturing systems in aqueous based cell technologies.New business growth: New products, new markets, customer development and existing product price enhancement.Strategic planning: Market assessment, SWOT, gap resolution, partnerships, actionable business and technology plans.Product development and launch: Project managem...

Consultant for Oncology Drug Targeting and Validation of Cell Based Assay DevelopmentPharmaceutical / biomedical research scientist with 34 years of experience in the area of oncology.Drug discovery research in the Cancer Department at Merck Research Labs.Demonstrated track record identifying protein targets involved in the cancer disease process and developing small molecules that inhibit their functional activity.Evaluate and integrate outcomes data from a variety of sources.Recognized as an excellent mentor and motivator of research staff and colleagues, capable of maintaining a high level of productivity and achieve program objectives....

Polymer Blends and Alloy Consultant: Thermoplastics and PVC FormulationsPolymer modification specializing in thermoplastics including all engineering resins and some thermosetting resins.Polymer product development, particularity for reinforced thermoplastic systems and polymer blends.Polymer blends and alloys technology and formulations.PVC formulations and property modification and optimization with additives.Polymer rheology.Polymer processing, particulars extrusion and injection molding.Polymer analysis and characterization.Polymer composites.Plastic and polymer impact resistance; technology of improving fracture and toughening of pol...

Innovative Electromechanical Designer and Parts BuilderDesign and construction of specialized technical testing equipment and device such as: Light pipe couplers, capacitive biosensors, robotic flexural tester, polymer electrolyte battery cells, translation stage for laser annealing and helium leak detector.Lead a five staff member optical waveguide fabrication group for a world leader in specialty glass and ceramics.Obtained funding for, and directed scientific research in micro/nanotechnology and micro fabrication laboratory.Devised reflective infrared spectroscopy methods for detecting asbestos in soil and air samples used to evaluate...

Pharmaceutical and Biotech Statistics Expert Providing Analysis and Experimental Design for Computational Biology and High Throughput Genomics and ProteomicsGenomics and bioinformatics research and development:Statistics, bioinformatics and data analysis consulting and the use of centric analytical software design and development.Statistical analysis for bioinformatics, microarray, genomics, miRNA, systems biology, gene networks and biomarker developments.Statistical support in work related to high throughput genomics and proteomics.Statistics, experimental design, software design, user interface specialization, data acquisition, testing a...

Canadian License Applications for Natural Health Products, Cosmetics and PharmaceuticalsPerforming key pre approval and post approval activities for drugs intended for the Canadian marketplace.Preparation of DIN applications for submission to Health Canada.Product license and site license applications and amendments for natural health care products.Drug establishment licenses for Canadian importers, packagers and distributors.Responses to Health Canada deficiency notices.Expert WitnessRelated to Notice of Compliance (NOC) issues.Independent Consultant,...

Consultant Specializing in Chemicals and Energy from Biomass and Toxic Metals, including Mercury, RemediationCarbohydrate chemistry synthesis and product and process development.Chemicals from biomass including cellulose derivatives.Green energy and biofuels product and process evaluations.Biofuels development.Synthetic organic chemistry manufacturing.Heavy metal remediation including mercury.Undisclosed Company, President, 2008 - PresentBusiness development strategy formulation.Leveraging environmental improvements.Independent Cons...

Chemical Synthesis Consultant of Natural Products for Medicinal ApplicationsSynthesis of natural products for medicinal applications.Understanding and cataloging of non-prescription drugs.Synthesis of aristolochic acid and derivatives.Synthesis of substituted indole-3-caboxamide compounds as local anesthetics.Photochemical synthesis of phenanthrenes.Synthesis of biotin analogs for biochemical enzymatic studies.Synthesis of anthracycline derivatives as anticancer drugs.Synthesis of novel heterocyclic ring systems as potential drugs.Education in medicinal chemistry and pharmacology.Poison ivy and poison oak remedies.

Microbiologist Consultant for Microbial Cell Culture and Fermentation, Process and Equipment Validation ExpertOver thirty years of research, development, QA/QC, technical service, validation, manufacturing and engineering management experience in the food, pharmaceutical and biotech industries.Design, construction, scale-up, start-up, validation and operation of biotechnology and pharmaceutical manufacturing equipment and processes.Validation activities for pharmaceutical processes, for example, in an aseptic fill and finish facility for ophthalmic and parenteral solutions.Microbial physiology, biochemistry and genetic mechanisms controll...