Senior Pharma Regulatory Consultant with Expertise in Strategic Planning, Development, US Regulatory Preparation, Documentation (IND ANDA, DMF, CTD) and Quality AssuranceExpediting pharmaceutical services in: Pharmaceutical regulatory, Quality Assurance (QA), global pharmaceutical support, investigational and drug development.Enhancement and development of regulatory affairs with an overall development of regulatory strategy for business models through evaluation and control of pipeline products for commercial and drug development venture companies.Building pharmaceutical regulatory departments and assessing their effectiveness in paralle...

Oncology Therapeutics, RNA/DNA Isolation-Purification, PCR-Cloning and Mutagenesis, In Vitro Transcription (IVT), In Vitro Diagnostic and Antibody Production.Biotechnology/Nanotechnology Industry Expert - Oncology Therapeutics, RNA/DNA Isolation-Purification, PCR-Cloning and Mutagenesis, In Vitro Transcription (IVT), In Vitro Diagnostic and Antibody Production. Endogenous Biomarker Characterization, Aptamer and Nucleic Acid Technology DevelopmentPharmaceutical and Biotechnology drug discovery, diagnostic research and development, business development.Identify and implement technologies in strategically relevant areas to maximize value...

Professional Electrical Engineer and Patent Consultant with Telecom, Military and Consumer Products Experience in Broadband Access Networks, Data Centers, and Cloud Computing.Intellectual Property ServicesPortfolio valuation and technical analysis.Application/claim drafting and prosecution.Licensing, litigation, and IPR (inter parties review) support (reverse engineering, claim charts, damages, depositions, etc.)USPTO (Patent and Trade Mark Office) registered patent agent.Technical and Managerial ServicesBroadband access networks; (i.e., PON, xDSL, DOCSIS, DBS/DVB, LTE, and Wi-Fi), wired, wireless, and optical interfaces, (i.e., COFDM, CW...

Metals-Materials Consultant with expertise in Abrasive Corrosion, Adhesive Wear Problems, Alloy Selection, Nonmetallic Materials, Surface Engineering, Hard Materials; Carbides, Powder Metallurgy Tool Steels, Plant and Equipment Evaluation. FASMPhysical metallurgy, corrosion science and wear of materials.Failure analysis - mechanical fracture, corrosion (wear of metals), ceramics and polymers.Selection and specification of a wide range of metallic alloys and materials to meet process or product requirements: Carbon, alloy, stainless and tool steels,copper, nickel, cobalt and titanium alloys and nonmetallic materials.Corrosion in aqueous, hi...

Petrochemical Thermal-Fluid Systems Analysis and Design Expert for the Oil and Gas, Defense, Nuclear, and Aerospace Industries Domestic and Abroad.Risk analysis, the assessment of facilities to withstand explosions and fires, computational fluid dynamics (CFD), combustion analysis, and explosives engineering.Development and application of numerical modeling tools to characterize problems.Developed an analysis tool titled RisqCAD to determine release rates from process failures and the associated gas dispersion and fires.Developed a CFD based analysis tool to analyze the vulnerability of facilities to accidental explosions, it is now licens...

Manufacturing, Engineering/Maintenance, Quality/Compliance Expert: Supply Chain, R&D, Operational Excellence, and EH&S. Pharmaceutical -Medical Turnarounds, Quality Systems, Regulatory Compliance, Process Improvement, Lean, Six-Sigma & Problem Solving Methodology, Environmental, Health & Safety, New Product Development & Launch, Strategic Vision, Planning & Execution, and Culture Development & Transformation SpecialistPharmaceutical and medical device strategic planning, organizational development, supply chain management, and business focus.Implementing creative and innovative processes and solutions from a strategic, overall perspectiv...

Chemical Engineer with expertise in FEL (Front End Loading) processes design and economic analysis for Hydrofluoric Acid Alkylate- High Octane RefineriesPetroleum refining business development management for the petrochemical and chemical industries.Petroleum project scope development, detailed process design, and project justification economics.Computer modeling of processing units on simulators (HYSIM, HYSYS, Aspen).Design and evaluation of petroleum processing equipment.Operating unit revamps and debottlenecking with key in process design.Identify plant environmental concerns and EPA regulations.FEL (Front End Loading) processes design...

Oil and Gas Production and Processing Facilities Design Expert: Pressure Relief Devices, Headers, Vent and Flare Stacks, and Chemical Plant Operations. Maintenance and troubleshooting, Process Safety Management (PSM)Plant Engineering follow-up, completion to closure. Reviewed PSM drawings and gatherer and develop process safety information for the operating facilities.Implement Management of Change (MOC) for the operating facilities.HYSYS process simulations of current and proposed new process to identify opportunities in operations improvements and/or revenue growth.Detail design of oil and gas production and processing facilities, det...

Chemical Engineering Strategy and Formulation Expertise in the Pharmaceutical, BioRefinery, Polysilicon-Solar Wafer and Perfumery Products Markets.Market research of green chemicals.Well versed with ChemCAD.Field experience in production and project.Green chemicals, Polymers, perfumery chemicals, ethanol and derivatives.Basic Engineering of 20 TPD biodiesel plant.Basic engineering of revamp of molasses to yeast plant.Basic engineering of 10 K TPA, maleic anhydride plant.Market research report on green chemicals, maleic anhydride.Cost estimation of catalyst project.

Process Engineering Expert with Design Experience Integrating Other Disciplines Including Instrument, Electrical and Mechanical Design in the Petrochemical IndustriesProcess engineering and design experience integrating other disciplines including instrument, electrical and mechanical design in the petrochemical industries.Fluent with Aspen process flow sheeting software and good working knowledge of Aspen HYSYS.Process operations and troubleshooting, hands-on console and outside operator experience.Operator training.Project economic analysis.OSHA 1910 compliance.TCEQ and USEPA compliance and permitting processes.Working in diverse operat...