Ph.D. Legal Consultant, Providing Various Expert Support in: FDA Approvals, Evaluations-Patents Medical Devices and Drugs, Data Integrity and Software Development, Author and Expert Report Writings.  Regulatory, Food and Drug Administration (FDA)-related provisions and cases providing support to legal clients in areas: Death or injury caused by drugs, biologics or medical devices, (patents, insurance claims, wrongful termination, trade secrets, merger and acquisitions. Develop and present more than 40 FDA related technical, regulatory and compliance topics to over 50,000 participants. Depositions. Develop case-specific informat...

Expert in acrylic emulsion polymerization chemical engineering, ink jet and pigment dispersion and coating rheology.Emulsion polymerization, process development, scale up, process control and steam stripping.Emulsion polymerization operational excellence.Effect of mixing and process variables on polymerization process.Quality, SPC, productivity, process safety of emulsion polymerization processes.Ultra low VOV latex.Intellectual Properties (IP) landscape mapping, new process pipeline initiative.China joint venture (equipments modification, technology transfer, startup the new plant, training, raw material qualification, QC).Continuously po...

Toxicology Consultant Specializing in Inhalation, In Vitro and High Content Screening, Consumer Product Additives, Tissue Regeneration Research, Cancer Cell Biology, Nutrition Research, Preclinical, Experimental Design and AnalysisPreclinical toxicology of consumer products. Design and manage external toxicity studies and summarize study reports. Research on natural compounds and cancer reversion, and toxin induced pathways involved in disease. Inhalation, reproductive, and in vitro toxicology. High content screening assays and new in vitro toxicology assay development. Proof-of-concept for new products, and regulatory toxicology (F...

Petrochemical Engineer Operations Manager Specializing in Facility Assessments, Operations, EH&S Practices. Expert Knowledge in Risk Reduction and Refinery Safety Management ProgramsRefinery safety management systems evaluation and recommendations.Fire and explosion investigations.Emergency response planning.Petrochemical operations and troubleshooting.Evaluations of refinery EH&S (Environmental Health and Safety) procedures and practices.Process improvement projects for refinery operations, EH&S practices.Improving petrochemical industry and regulatory agencies communication.Expert Witness ExperienceRefinery and petrochemical process oper...

Pharmaceutical Regulatory Affairs Consulting in: Project Management, Quality and Compliance - NDA, ANDA, DMF and eCTD - Domestic and InternationalHigh-performing Regulatory Affairs and Compliance Professional with over 25 years of diverse pharmaceutical experience in sterile injectable, solid dosage, oral solution, and inhalation product environments. Demonstrated knowledge of regulations and the NDA/ANDA/DMF eCTD submission process with a successful track record in obtaining over 200 drug product approvals. Proven expertise in negotiating effectively with the U.S. FDA applying broad understanding and experience in handling p...

Ph.D. Metallurgist with Expertise in the Oil and Gas Industry: Regulatory Compliance, Corrosion and Management, International Standards-Implications on HSE and Regulatory Requirements.Oil and gas operations oversite, risk corrosion and H2S management technologist. Materials specialist for the oil and gas industries. Energy alloys providing technical services in metallurgy and materials worldwide. Sour services (H2S, hydrogen sulphide) and technical support, domestic and abroad. Asset Integrity Management specialist in the oil and gas industry. Metallurgist with proven record in the oil and gas industry. Corrosion specialist servici...

Industrial Gasses (Oxygen, Nitrogen, Liquid Nitrogen) Refining Applications and Vessel Consultant: Fluid Catalytic Cracking, Sulphur Recovery Units, Nitrogen Cryogenics, Tank Inerting and PurgingImplementing Gases Technologies into RefiningIndustrial gas industry production: Methods, supply modes, application technology, identifying hazards, creating safe practices in design, engineering, fabrication, and operation.Oxygen enrichment of combustion processes such as fluid catalytic cracking (FCC), sulfur recovery units (SRU), cement clinker, lime kiln, and non-ferrous metal melting.Oxygen enrichment of chemical oxidation processes such as c...

Phosphates, Phosphoric Acid, and Alkali Process Development ConsultantChemical and process development.Analytical method development.Membrane filtration and separation.Carbon treatment and absorption.Solvent extraction of phosphoric acid.Electrochemical cell operation.Crystallization processes for carbonates, phosphates and peroxides.Ion exchange processes to remove heavy metals.Processing of phosphate salts including dipotassium phosphate (DKP).Statistical process control.Experimental design.Undisclosed Company, Senior Chemist and Laboratory Manager, 2007 - PresentGlass...

Accounting Specialist with Focus to: Full Cycle Accounting, Bookkeeping, Reconciliations, Balance Sheet Presentation, Profit and Loss Reporting Fully Cycle Accounting Public Accounting Payroll Cash Management Sales Tax Submission Auditing Income Tax Preparation Financial Presentation QuickBooks Online and Desktop Certified Pro Advisor E.B.B.LLC, President, 2016 - Present Bookkeeping and accounting services. Business and corporation start-ups. Reconciliations. Catch-up accounting P...

Construction Consultant Specializing in Glass, Mirrors, Curtain Walls, and Building Envelope Failure for National and International Insurance, Construction, and Legal firmsSpecialist in windows, glass, mirrors, curtain walls, entrances, skylights, panel systems, louvers, window films, sealants and similar architectural products. Over 30 years' experience in construction materials, particularly window systems, curtain walls and skylights. Consulting experience includes laboratory and field testing, forensic investigations, insurance claims and expert work on window systems. Expert work related to component use and performance to window...