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Testifying Chemical Engineering Expert and Investigator for Multiple Chemical Exposure and Environmental Cases for EPA, US DOJ, USDOL-OSHA, and Civil and Criminal casesExpert Witness In:Toxic chemical exposure.Explosions and fires.Regulatory agency enforcement.Medical devices.Environmental contamination.Animal farming nuisance.Railroad tank car accidents.Methamphetamine labs.Industrial and consumer products.Chemical burns.Business interruption loss.Chemical patents.Expert witness for the automotive industry covering, seat belts, airbags, infant and child seats.Retained as expert for U. S. Department of Justice, U. S. Environmental Protecti...
Broad Based Health Care Regulatory Consultant: Operational Excellence, IT, Product Portfolio Management, Health Care Product Portfolio Management and Quality System ConsultantOver 16 years in the pharmaceutical, medical device, biotechnology and healthcare industries.Subject matter expert in health care product portfolio management, project management, operational excellence, quality system improvements, system development life cycle (SDLC), computer system validation (CSV) and regulatory compliance in global operations.Assessments of business operations, quality assurance programs, regulatory, compliance, information technology and manufa...
Strategic CMC development and planning of ophthalmic, respiratory, and nasal products. Formulation development of ophthalmic, respiratory, nasal, and dermatological productsStrategic CMC development and planning of ophthalmic, respiratory, and nasal products.Formulation development of ophthalmic, respiratory, nasal, and dermatological products.Manufacturing process development, technology transfer, and scale-up of ophthalmic, respiratory, and nasal products.Extractables and leachables testing planning and execution for ophthalmic, respiratory, and nasal products.CMC regulatory writer: Pharmaceutical development and stability reports; CMC...
Energy and Power Plant Expert for Combustion Turbine Plants, Nuclear Plants, Petrochemical Power Plants, Coal Plants, and Boiler Islands.Environmental project and permitting management for electrical power plants.Design, construction, and startup or electric and petrochemical power plants.Combined cycle project development.Integrated gasification technology development.Clean air act and multi-pollutant compliance project implementation.Power plant betterment/life extension project implementation.Chemical plant/power plant startup and commissioning.
Clinical and Legal Nurse Expert Specializing in all Aspects of Medical Device Product Development and Regulatory StrategyProduct development expert in recognition of clinical problems that can generate important medical device solutions that meet or exceed sales expectation.Clinical Research Director for large Maternal Infant Care (MIC) Medical Device Business.Expert in developing claims and regulatory strategy for product development.Patient safety and clinical risk assessment process for MIC portfolio.Risk assessment activities during product development.Planned and directed pre and post-market research projects with more than 60 studies...
Consultant and Expert Witness for Building Diagnostics, Building Roofs and Curtain Wall ConstructionBuilding diagnostics and building condition surveys.Building envelope evaluations.Construction testing and constructability analysis.Infrared thermography.Non-destructive moisture surveys; nuclear moisture meter; roof moisture problem analysis and roof moisture surveys.Building quality assurance and performance evaluations.Building forensic studies and litigation support.Roofing: Built up, single ply, and metal roofing.Window performance analysis and curtain wall designs.Building sealants, below grade waterproofing and plaza deck waterproof...
Professional chemical engineer with over 40 years of experience in the petroleum refining, chemical and petrochemical industries.Professional chemical engineer with over 40 years of experience in the petroleum refining, chemical and petrochemical industries.Extensive technical engineering and business skills with strong emphasis towards economics and cost controls, competitive analyses, project management, acquisitions and divestitures. project management.Undisclosed Company, President, 1978 - PresentCompleted p...
Mining and Refinery Operations Consultant: Best Practices, Reliability and SafetyOpen pit and underground mining operations and management.Open pit coal mining operations.Mining equipment purchasing, operation, utility of use and maintenance.Petroleum and refinery operations, including coker operations.Process Hazards Analysis (PHA) Certified Trained Leader and Occupational Safety & Health (OSHA 1910) Certified Training Guide Development.Turnaround optimization and defect elimination programs at major mining and petrochemical facilities.Identification of operational improvements and implement of plans for oil and mining operations, resu...
Chemical Engineer Consultant: Water, Process Utilities, Sustainable Fuels and Biomass to Energy.Pharmaceutical water system design, equipment, pharmaceutical water standards, P&ID, facilities construction and validation.Process engineering expert with a focus on water treatment facilities, process utilities, sustainable fuels, petrochemicals and biomass to energy.Analysis of construction contracts, engineering claims and engineering standard of care issues for process design and construction.Twenty years of experience in membrane filtration with a focus on pharmaceutical and biotechnology waters, water for injections and purified water sy...
Life Sciences Consultant Specializing in Intellectual Property, Marketing, Business Development, R&D, Product Development, Product Evaluation, Manufacturing, and International Sales (Biotechnology and Pharmaceutical Industries)Over 20 years of Life Sciences experience in academia, government and biotechnology and pharmaceutical industries.Scientific discovery, development and marketing knowledge for pharmaceuticals and diagnostic equipment medical devices.Development of novel high-throughput screening products for crystallography, genomic, and proteomic technologies.Development of automated and miniaturized biologic testing kits for nuclei...