Polymer and Nano-Composite Innovator and Expert for Aircraft, Automotive, Construction, Medical Equipment, Major Appliances and Sporting GoodsResearch and development and research management in polymeric materials systems, particularity polycarbonate polymers and plastic blends.Polymer manufacturing processes and application development and validation testing for thermoplastic and thermoset polymers.Intellectual property strategy and management related to polymer types, polymer manufacturing and polymer applications.Patent, trademark and portfolio analysis; license agreements; innovation techniques; strategic portfolio leveraging.Automotiv...

Pharmaceutical Quality Auditor: Excipient GMP auditing, International IPEA, and ISO standards, 9001, 17025, 14065Certified Quality Auditor with 20 years experience of working with quality systems.Trained in a number of ISO standards, Pharmaceutical Excipient GMP auditing and is an approved auditor for International Pharmaceutical Excipients Auditing (IPEA).Experienced with ISO 9001, ISO 17025, ISO 14065 and Lexcel, Law Society's practice management standard.Undisclosed Company, Director, 2008 - PresentA consulting firm servici...

FDA Regulatory Compliance Expert for Medical Devices and PharmaceuticalsNew medical device product development and transfer to manufacturing.Compliance consulting to medical device and pharmaceutical clients.Writing and executing validation documents for new medical device facilities.Remediation of 483 and warning letters.Thorough knowledge of FDA regulations with particular expertise in design controls, controlled documentation, validations and change control.Project management expert.Undisclosed Company, Senior Consultant, 2001 - PresentPharmaceutical consultant for...

Low Loss Polymer Materials Consultant and Polymer Expert: Telecommunications, Wire, Cable, Antenna, Testing, and Plastic Flame Retardant SystemsPolymer selection for telecommunications equipment, wire, and cable applications.Real time polymer degradation, stabilization and failure analysis.Flame retardant polymers for wire and cable.Flame, smoke and toxicity testing protocols on wire and cable products.Characterization and analysis of polymers and polymer additives.Low dielectric loss polymer materials.Low dielectric loss and ultra low density foam insulation for coaxial cables.Polymer structure-property relationships.Global materials sou...

Analytical Chemistry Consultant for Drug Development, Drug Identity and Expert Witness for Patent LitigationDrug development focused on chemistry manufacturing and control for drug substances and drug products.Analytical method development, validation, technology transfer, trouble-shooting.HPLC, GC, chiral analysis, other separations techniques, trace analysis.Physical property and solid state characterization, polymorphism, crystal form, particle size.IND, NDA, CTD regulatory document preparation, briefing documents for end-of-phase 2 meetings, pre-NDA meetings, responding to regulatory questions.Pharmacopeial monograph development, ant...

Medical Devise Regulatory Affairs - Audits: ISO 13485, cGMP Part 211, Due Diligence, GCP, (QSIT), (QSR), CAPA , Failure Investigations, FDA- 483 (OOS), SOP, IDE and PMA,LED lighting optical design, component and patent analysis (LED, OLED, lenses, diffusers, lightguides, edge-lit, edge-illuminated, panels, downlights, bulbs, remote phosphor).Optical film design and analysis (prismatic, reflective, refractive, retroreflective, TIR, total internal reflection).Display and backlight technology (edge-lit, LED, lightguide, light extraction, laser scribing, screenprinting), BEF films, diffusion films and prismatic films.Intellectual property...

Chemical Laboratory Manger Supporting Specialty Chemical and Plastic ManufacturingSenior quality control and quality assurance manager with extensive experience, including plastics, ion exchange resins, bulk pharmaceuticals and agricultural herbicides.Managed three quality control laboratories in the past twenty years with up to eight chemists and analysts.GC, HPLC and FTIR, including training, troubleshooting and method development procedures.Installed and managed client server, TotalChrom Lab Data and control system.Managed in-house and contract quality cGLP assurance and control lab.Developed new test methods and introduced new "Fast GC...

Consultant for Characterization of Nanomaterial SurfacesPolarimetry techniques to study surfaces and periodic structures.Polarimetry technology applied to lithography and photonic structures.Mueller polarimetry and Mueller matrices optics and advanced developments.Metrology technology, metrology study groups and metrology equipment suppliers.Optical and polarization characterization of nanomaterials.Optic instrumentation applied to thin films deposition technologies including epitaxial deposited thin films.Optics thin films Instrumentation: spectroellipsometry (SE), Infrared (IRSE) and Ultra Violet Ellipsometry (VUVSE).Thin films semicond...

Expert in Refiner Maintenance Turnaround Specializing in Heavy Crude Oil RefineriesTen years experience in refinery maintenance operation processing heavy oils (crude, coker and cat); worked as a maintenance superintendent.Responsible for all day to day routine maintenance as well as turnarounds and preventive maintenance on fluid cat crackers, crude units and fluid coker.Involved in refinery turnaround (T/A) maintenance of 30 years. Participated in every level of the turnaround process for every major turnaround on the fluid cat cracker, crude unit and fluid coker at the Delaware City Refinery.Oil refining and energy expert in the field...

High Power Electron Beams Technology and Business ConsultantTechnical and business expertise for industrial electron accelerator projects.Led the team that developed Atomic Energy of Canada's high energy, high power electron beam technology.Managed research and development programs to develop new uses for electron beams, including food irradiation, plastics, composites and cellulose treatment.Evaluate products for feasibility of electron beam sterilization - including materials compatibility, dose distribution and process efficiency.Determine electronic beam equipment requirements - power, energy and other.Estimate dose distributions and p...