Pharmaceutical Statistics Data Analysis and Clinical Trial DesignPharmaceutical bio-statistician.Pharmacokinetics and data analysis for clinical trials.CNS: Schizophrenia, bipolar disorder, Alzheimer's disease, migraine and over-active bladder.CV: Hyperlipidemia, diabetes (novel PPAR y & %u0105, atrial fibrillation, anti-platelet agent.Oncology: VEGFR EGFR inhibitors, lung and thyroid cancer, non-small cell lung cancer, chronic lymphocytic leukemia (CLL), acute myeloid leukemia (AML), advanced solid tumors.Immunology: Malignant melanoma (DNA immunotherapy, hepatitis B and C (PEG-Inetrferon), H5N1 vaccine, RNAactive-derived vaccine (for p...

Chemical and Biopharma Trade Consultant, Licensed Customs BrokerOrganic and medicinal chemist with import, export, and economic sanctions experience. Provides import (Harmonized Tariff Schedule) and export (Schedule B and ECCN) classifications. Assists with import requirements of partner government agencies e.g. USDA, FDA, FWS. Chemical and biopharmaceutical product import classifications for the global Harmonized Schedule (HS) and the Harmonized Tariff Schedule of the United States (HTSUS). Export control regulatory compliance of the U.S. Department of Commerce, Bureau of Industry and Security (BIS). Export classifications to give Sc...

API Quality Assurance, SOPs, batch production records and protocols, CAPA and SMF Activities, Clean Room ValidationsCompliance to cGMP Systems and Regulatory requirements. Application risk assessment, as applicable at various QMS documentation. Review of all the SOPs, batch production records and protocols (validation and qualifications) prior to the approval along with change request forms. Review of all equipment qualification documents like reactors, centrifuges, different types of dryers, blenders, powder process equipment etc., (DQ, IQ, OQ, PQ) and related test reports. Review of clean room HVAC qualification documents and relat...

Lab Testing Design: Drugs-Pharmaceutical Testing, Lab Operations, Maintenance, and Quality Control of Drug Testing Labs: Toxicology, Cannabis, Bioequivalence), Regulatory Requirements, BioequivalencSummary Over 17 years of drug testing experience on the development, validation, and application of analytical methods.  Equal experience in drug testing Labs design, operation, maintenance, and quality control of drug testing labs: Toxicology, cannabis, drugs, bioequivalence), cannabis regulatory requirements, bioequivalence studies, quality control studies, analytical laboratories’ quality assurance procedures.&n...

Consulting and manufacturing expert focusing on silicone products and technology. Manufacture customized formulations of specialty silicone adhesives, sealants, gels and coatings.Custom manufacturing and formulation of specialty silicone adhesives, sealants, gels and coatings.Owner of fully equipped labs to develop and characterize coatings, both thixotropic and self-leveling sealants and adhesives, thermally conductive products, high temperature stable products, greases, compounds, and many cure chemistries.Specific silicone experience including: Silicone coatings and adhesives (both thixotropic and self-leveling), silicone sealants, the...

Dietary Supplement and Functional Food Consultant Specializing in NPD Innovation and Quality/GMP ComplianceNatural product development and formulation; vet new product opportunities: Navigating IP infringement avoidance, scientific validation, efficacy, dosage, market viability, and regulatory compliance. Natural product ingredient assessments, technical review, and scientific approval. Provide marketing content, direction and guidance for new product launch. New product positioning and marketing strategy, product naming and tag line creation. Natural product: Product quality and marketing integrity: IP protection, regulatory complia...

Consultant for Internal Combustion Engines, Combustion Technology, Alternative Fuels, Emissions and Exhaust TreatmentConventional and alternative fuels for passenger cars and trucks.Gasoline and diesel engine combustion.Exhaust gas analysis.Gasoline and diesel exhaust after treatment (TWC, DOC, fuel reformer, LNT, SCR, DPF).Undisclosed University, Assistant Research Scientist, 2003 - PresentGasoline combustion technology.Exhaust after treatment and catalysis of gasoline engine emissions.Exhaust hydrocarbon identification and...

Power Train Expert Specializing in Research and Development, Advanced Engineering, Technology Planning and Strategy.Senior Power Train Technologist specializing in research and development, advanced engineering, technology planning and strategy.Pragmatic, results-oriented engineering executive and mentor with extensive background in leading powertrain developments and technical strategies for global companies.Proven ability to lead developments of "game changing" technologies.Emissions and after treatment.Renewable fuels and CO2 reduction.Technology assessment and planning.International training and team building.Core competency and new bu...

Ph.D. with Metallurgy Experience and NACE Corrosion Specialist with Expertise in Oil and Gas Production, Refining, and Transport35 years of experience with corrosion, materials engineering, water treating, inspection, fabrication, and pipeline engineering for oil and gas refineries.All phases of refinery materials engineering projects.Exxon Research and EngineeringSenior Engineering Associate (and other technical positions)Technical leader of materials engineering section.Implemented new materials and developed st...