Expert in applied statistics, biostatistics and mathematics - designs analyses for clinical trials, pharmaceutical exposure and efficacy, Medicare/Medicaid effectiveness and learning methodologiesClinical trials protocols, statistical analysis plan and clinical study reports.Bayesian inferential and decision analysis.Integrated Analyses of Efficacy and Safety.Due diligence.Pharmaceutical adaptive designs: blinded and un-blinded sample size adjustment, group sequential designs.Clinical trials sample size determination.Mixed models repeated measures models.Pharmaceutical product exposure modeling.Statistical programming in SAS (MACROs, IML,...

Developing Abradable Coatings for Ceramic Matrix Composites, Develop New Processes such as Chemical Vapor Deposition and Thermal Barrier Coatings, and Super alloy DevelopmentSummary Materials researcher and manager providing many years of diverse managerial and technical experience in process and product development, primarily with companies requiring “world class” level of product quality, including wide experience in gas turbine materials and coatings. New processes development and introduction into production.  Specific areas of knowledge in chemical vapor deposition; oxidation and corrosion; diffusion coatings; thermal barri...

Chemical Process and Catalyst Technology Evaluation, Licensing, Patent Analysis, Sales and Marketing, Mergers & Acquisitions, Market Studies, & Strategic PlanningCatalyst and Process Technologies ProductionAcetic acid and acetic anhydride.1,4-butanediol, tetrahydrofuran and gamma butyrolactone.n-butanol and isobutanol, n-butyraldehyde, isobutyraldehyde, 2-ethylhexanol.Carbon dioxide and carbon monoxide.Ethylene, ethylene oxide, ethylene glycols, ethylene glycol ethers, ethanolamines, ethyleneamines, ethoxylates, and polyetherpolyols..Formaldehyde and formic acid.Hydrogen and hydrogen peroxide.Maleic anhydride and phthalic anhydride.Methyl...

Ph.D. Electrical- Professional Engineer-Possessing Numerous Certifications and Licenses Execution of various Projects in overseeing; maintenance of petrochemical and oil refineries, fertilizer plants,Summary Electric Engineer executing detail design, engineering management, and project management in the energy and petrochemical industries.  This includes petrochemical-oil refinery operations, EIC-Engineer, Charge Management overseeing; maintenance of petrochemical and oil refineries, fertilizer plants, CTL (Coal To Liquid), oil and gas commissioning, refinery oil and gas infrastructure, LNG (Liquid Natural Gas) and Coal Mining. ...

Licensed Pharmacist Skilled with Patent Litigation and Pharmaceutical Product Development Projects, Including Regulatory IssuesExpert Witness for pharmaceutical patent litigation.Pharmaceutical reformulation and the physical-chemical characterization of new chemical entities (NCE) and APIs.X-Ray diffraction, polymorphism, solubilization, stabilization and kinetics of pharmaceutical materials.Author of regulatory (IND/NDA/CTD) CMC sections and support documents.Project planning and management for pharmaceutical development projects, including virtual contract research (CRO) companies.Pharmaceutical method development preformulation and pilo...

Plastic Extrusion Consultant Focused of Plastic FilmsInternationally recognized consultant in film processing and formulation.Expert in plastics processing techniques including blow molding and extrusion.Extensive knowledge of plastics processing equipment design.Screw and die design.Polymer raw material selection.Polymer film process troubleshooting.Plastic processing equipment specifications and capital equipment procurement.Expertise in physical and chemical test methods used in the plastics fabrication and packaging industries.On-site training for production staff.Product design.Quality control.Project management.Expert witness testimo...

Plastic Compounding Consulting Expert with Twin-Screw Extrusion and Plastics Testing Laboratory and Underwriters Laboratories Experience and Significant Far East Experience30 years of plastics testing and consulting businesses with continuing Asian technical and business contacts. In-depth technical and operations knowledge of plastics processing and compounding. Formulations expert in polyethylene (PE), polypropylene (PP), polybutylene terephthalate (PBT), nylon, polycarbonate (PC) and alloys, acrylonitrile-butadiene-styrene (ABS) and other engineering resins. Process design and experience in single screw, twin screw and FMC compound...

Very Experienced Chemical Engineer for Polymers and Elastomer Plant Design and Operations Expert in Polymer DevolatilizationSummaryOver 25 years of chemical engineering experience in the polymer and chemical industries. Proven ability to commercialize new products and processes in a cost-effective and schedule-driven manner. Engineering work includes process concept, pilot plant, plant design, construction, operator training and start-up and commercial operation. Broad development, chemical engineering, manufacturing base in plastics, elastomers and chemicals.Specific ExpertiseChemical engineering technology development.Pilot plant desi...

Ph.D. Analytical Expert in Pharmaceutical Development and Sustenance from Development through Registration Stability.Drug product development: Global leadership to analytical teams responsible for developing and sustaining drug products from development, registration stability, regulatory submission, and commercial launch. CRO management: Direct Global teams responsible for strategic alliances with Indian CROs (200 FTEs for new products and product sustenance) with an annual budget of about $14 million Analytical: Method validations, troubleshooting, and SOPs using a variety of techniques such as UPLC, HPLC, GC, IC, SEC, GPC, AA, ICP-M...

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...