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Intellectual Property and Regulatory Consultant Specializing in Patents on and FDA Regulation of Novel Medical Device and Biotech DevicesIntellectual property (IP) and regulatory strategy.FDA regulation of novel products such as wearable medical devices, and electronic cigarettes.Patent protection of drugs, medical devices, dietary supplements, and tobacco products.Patent landscaping and freedom-to-operate analyses.Consultation with and representation before U.S. Food and Drug Administration (FDA).IP and regulation surrounding novel technologies such as RNAi, gene editing, and synthetic biology.In vitro diagnostic medical device and consu...
Development and Design of High Current Electronics (Power Supplies, Amplifiers, AC and DC Converters), Automotive Starters and AlternatorsDevelopment and design of various switching power supplies with an emphasis on the development of soft switch and resonant power conversion systems; energy systems; and power amplifiers.Development and design of various electronic devices for automobiles; charge units and welding devices; starters and alternators.Cost effective solutions and reliable design in the electronics and high power industry.Complete design systems: Algorithms, magnetic component calculation, packaging and PCB.Power electronics...
Analytical Chemistry Consultant Specializing in Drug Stability and cGMP, FDA, and ICH Quality and ComplianceManage pharmaceutical commercial internal-external stability programs providing, guidance for laboratory investigations, input for laboratory information management systems, support sample management programs, and support data review. Provide support to Operational Excellence Projects.Ensuring stability studies are conducted to support regulatory commitments.Communicating trending stability data from the QC laboratory and contract laboratories.Drug stability program management for development and commercial products.Statistical anal...
Composites Mechanical Engineer with expertise in Design and Development, Quality Assurance, and Project Management for Plastics, Fiberglass, PVC and FRPComposites design and development in the plastics, fiberglass, PolyVinyl Chloride (PVC), Fiber Reinforced Polymer FRP.Composites Material analysis and testing.Composites manufacturing processes such as RIM, VARTM, Centrifugal casting, pultrusion, hand Lay-up, and continuous lamination.Quality Management and continuous improvement.Statistical analysis (Six Sigma - Black Belt).Project management.Product costing.
Rotating Equipment and Mechanical Failure Specialist in Petroleum, Synthetic Rubber, Sulfur Units, Pumps, Steam Boilers, and Olefins Cracking UnitsOver 30 years of experience in the machinery engineering, specializing in rotating equipment for the oil production, refining, and petrochemical industries.Pumps specialist; small metering pumps to ANSI, UMD, API pumps.Vessel mixers and CT fans, reciprocating compressors, integral gas engines.Pump reliability improvements beyond 100 months and compressor care programs.500-20,000 HP range Centrifugal Compressor and Gas Turbines in both mechanical drive and Cogen applications.Waste heat boilers an...
Petrochemical Commercialization Processes, Heavy End Upgrading and Clean Fuels Manufacturing, GTL Alternative Energy ProcessesSpecialization in syngas processes, Gas to Liquid (GTL), novel clean fuels technologies, and alternative energy processes as well as refining, gas processing, and petrochemicals industries.Development and commercialization of a variety of process technologies related to light gas processing, heavy end upgrading, and clean fuels manufacture.Identifying, assessing, and championing novel technology opportunities and solutions for integration into the company's assets.Consultant to major US. and international firms such...
Ph.D. Cosmetic and Personal Care Consultant with Expertise in Bio-Active Complexes for Formulation, Claim Substantiation, Active Ingredients, INCI Regulations, Skin Care, and Hair CareIdentifying and developing innovative biologically active raw materials leading to the formulation of successful skin care and topical dermatological OTC products.Development of formulations by designing the bio-active ingredient combinations.Help oversee In vitro and In vivo activity testing.Develop product claims and claim substantiation.Work with marketing and public relations to communicate technology to the press and consumers.Knowledge of labeling regu...
PhD Biology Consultant with Expertise in DNA-RNA Identifying and Sequencing, and Analysis of Genotyping and Expression MicroarraysGenomics, bioinformatics and biotechnology.Chip-seq, RNA-seq, DNA re-sequencing and de novo analysis.Analysis of Genotyping and Expression Microarrays.Strong programming experience with Perl, Bash, Java, R, and MySQL.Thorough knowledge of standard bioinformatics tools including UCSC and NCBI.High-performance computing including SGE clusters.Expert Witness ExperienceAnalyzed GenBank and PubMed to identify prior art for the BRCA1 patent litigation.
Industrial Organic Chemist with expertise in Acrylics, Smart Polymers, Small Molecules, Protein Synthesis. Patent Determination, and PatentabilityAcrylic polymer technology synthesis and technology.Development of acrylic polymer products for automotive and medical device markets.Smart polymers and optical control film.High heat acrylic polymers.Licensed U.S. Patent Agent specific to chemistry; organic chemistry, small molecules, polymers, plastics, medical devices, membrane filter contactors, and UV (Ultra Violet) curable nail gels.Patent portfolio planning and management: trademarks and copyrights.
Safety Assessment Expert - Chemical Hazards, Root Cause Analysis EH&S ConsultantHazard and risk assessments: Identification and quantification of hazards and risks, definition of practical protection measuresRoot cause analysis: Incident investigation, determining the cause and effect relationship and defining effective preventive measures.Working to systematically and significantly improve process safety performance in a sustainable fashion.Manufacturing performance improvements: Incident rate reduction, yields, and cycle time reduction.Expert Witness ExperienceConsultation and root cause analysis for engineering firm and law firm represe...