Optical Sensor Expert Technologist: Optical Sensor Devices Development, Analytical Instrumentation and Spectroscopy (FTIR) ApplicationsSensor expert, particluarly optical sensors.Development and application of analytical instrumentation and their use of sensors.Development and manufacturing of specialized instruments, miniaturized instrumentation and use of optical sensor-oriented systems.Expert for optical sensor devices for automotive applications such as oil, fuels and lubrication measurement.Fourier transform infrared spectroscopy (FTIR) application and marketing.Sensor expert witness services for analytical, spectroscopic and instrum...

Expert in analytical chemistry for pharmaceuticals, FDA issues and detection of bio hazards for Homeland SecurityCenter for Drug Evaluation and Research (CDER), former FDA employee.FDA review of new drug (NDA) and generic drug (ANSA) application submissions, FDA national Field operations, FDA compliance.Research and development programs related to homeland security.Department of Defense force protection and agent detection (novel devices, sensors and samplers) for the detection and identification of chemical and biological agents.Technology related to infectious disease countermeasures.Analytical chemistry related to drugs.Pharmaceutical a...

Polymer and Plastic Additive Consultant with Strong Analytical Skills and Plastic and Olefin Application ExperiencePolymer material analysis expert for amorphous and crystalline polymers in commercial markets.Plastic and polymer physical property analysis and stabilization of properties.Molecular modifications and use of compatabilizers to reuse waste plastic materials for new products, such as recycled tire rubber and carpet fiber wastes.Polymer additive expert: Plastic additives, plastic antioxidants, UV stabilizers, fillers, minerals and lubricants.Plastic color concentrate expert focusing on plastic colorants, discoloration, pigment,...

Analytical chemist specializing characterization and analysis of unknown materials, laboratory operations and REACH compliance, Certified Quality Auditor, CQA,Specialize in the analytical in-process / laboratory problem resolution and cGMP auditing / compliance and gap analysis of pharmaceutical suppliers.Process analytical technology solutions and project management.Preparations for REACH compliance in the European Union (EU).Established a satellite pharmaceutical testing laboratory in Hyderabad, India.Pharmaceutical ingredient supplier (cGMP) auditing (ASQ-CQA) including quality systems and regulatory affairs.Qualification of Asian sun...

Pharmaceutical Consultant Specializing in Drug Dissolution, Liquefaction, Laboratory Management and Regulatory ComplianceDissolution (reduction to a liquid form; liquefaction) method development, validation, transfer and troubleshooting.HPLC method development, validation and transfer.Laboratory instrument qualification and calibration.GMPs/ICH/USP: laboratory Quality Assurance and regulatory inspection readiness.Regulatory specification development.Preparation of the CMC (Chemistry, Manufacturing and Controls) section of IND (Investigational New Drug) and eCTD (Electronic Common Technical Document).Development of SOPs and Quality System...

Analytical Chemistry Consultant for Size Exclusion Chromatography (SEC)SummarySize Exclusion Chromatography (SEC, also known as Gel Permeation Chromatography, GPC) and its application to the compositional and failure analysis of polymers for pharmaceutical, medical device and the chemical Industry. Specific SEC experience includes:Molecular mass distribution (MMD) of natural and synthetic polymers, blends and oligomers.Analytical method development, validation, transfer, stability studies, quality control, cleanup and release testing procedures.Environmental resistance of polymers, including chemical exposure, oxidative resistance, weathe...

Drug Stability and Drug Quality Consultant and Analytical ChemistProduct experience includes brand, generic and drug substance (active pharmaceutical ingredient, API); small molecules, biologics, vaccines; Rx and OTC products; oral, topical, and parenteral dosage forms.Pharmaceutical compliance and remediation, quality systems management, data integrity audits, product quality assessments, gap assessments, batch reviews, laboratory and manufacturing oversight.Authoring of policies, procedures, training programs. Technical and business writing, editing, and proofreading: Proposals, quality agreements, standard operating procedures (SOPs), p...

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...

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...