PhD with expertise in Pharmaceutical Assessments, Investigations, 3rd party certifier, and Regulatory; FDA EMA, MHRAOver 33 years' experience in quality, microbiology and regulatory affairs.Pharmaceutical assessments, prioritization, establishment of realistic timelines for the implementation of consent decree commitments and 3rd party certifier of deviations-investigations.Ensure the robustness of quality systems - change control, product complaint handling, revision of SOPs, and control of 3rd parties.Quality assessment of sterile injectable, small molecules and biological as well as other dosage forms.Solid and liquid oral dosage forms...

Regulatory Pharmaceutical Compliance Consultant with Expertise in Clinical, Pharmacovigilance, Biologics, Biosimilars, Orphan Drug, Medical Device, Natural Health Product, Dietary Supplement, Cosmetic, and Food.Regulatory strategy, pathways and gap analyses.Regulatory submissions and applications for diverse product types to global regulatory agencies: Health Canada, US FDA and EU EMA (CTA, IND, IDE, DMF, NDS, SNDS, ANDS, SANDS, DIN, NDA, NDA 505(b)(2), BLA, ANDA, PAS, CBE, CBE-30, 510(k), PMA, HUD, HDE, Class II, III and IV Device License Applications, ITA, MAA, Type I and II variations, Technical File, PLA, Amendments, Notifications, a...

Pharmaceutical Development Expert: Planning, Portfolio, Technical Analysis and LicensingPharmaceutical and biotechnology business development and new product planning.In and Out licensing and strategic partnering.Commercial analysis and forecasting.Pharmaceutical life cycle management.Start-up of Pharmaceuticals, business building in proprietary, generic, and OTC pharmaceuticals and biotechnology, providing modeling and commercial assessments.Undisclosed Company, Chief Consultant, 2014 - PresentPrepared for pharmaceutical start-up forecast models and...

Consultant for Electroslag Remelting (ESR) Metal TechnologyProduction of high quality metals.Electroslag remelting (ESR) technology.Steel making technology and steel alloys.Theory of metallurgical processes.Production of titanium and titanium alloys with ESR.Independent Consultant, PresentTimken Latrobe Steel, Latrobe, PA , Principal Research Engineer, 1998 - 2001Introduced new variants of de-oxidation and modification of the steel in the AOD and in the ladle.Developed and introduced new practice of electroslag remelting with low-level hydrogen and oxides in ESR metal.GE Corporate...

Chemical Engineer Specializing in Fractionation and Distillation Processes, Debottlenecking Projects, and Waste Management ConsultationThirty years of experience in fractionation, distillation, and other separation processes for the petroleum and chemical industries.Areas of expertise include separation sequence development, FCC flue gas scrubbing, modeling and simulation using commercial (PRO/II) and other proprietary simulators, troubleshooting, debottlenecking, operations support, and waste water stream treatment.

Design and Implementation of Onsite Energy Systems Including CHP, Central and Distributed Utilities, Renewable Energy and Utility Rate TariffsConceptualization, evaluation, design, specification and implementation of power plant systems and equipment.Economic evaluation of Combined Heat and Power (CHP), Distributed Generation (DG), District Energy Systems and Central Station power plants.Thermodynamic and economic modeling of complex energy systems.Economic optimization and life cycle cost, Levelized Cost of Energy, LCOE evaluations of complex energy systems.Ocean Thermal Energy Conversion (OTEC) technology.Power Plant equipment including...

Analytical and Physical Chemistry Expert for Carbon Nanotubed-Based Materialslaboratories and production environments.Assess, diagnose, design and teach novel preparation, run, and mechanics of the following instrumentation and tools: Scanning Probe.Analytical and physical chemistry laboratory and production processes.Synthesis and characterization of hierarchically-nanostructured second generation carbon matrix composite materials.Electronic and photonic measurement at the macroscale, through the microscale, and into the sub-nanoscale.Nanoscale catalyst deposition and design expertise for templated nanoarchitecture.

Consumer Product and Pharmaceutical Market Research Consultant, Specializing in Quantitative and Qualitative Marketing Research Among Consumers and Health Care Professionals.Concept/Positioning: Insight, benefits, RTB (Reason To Believe) optimization and claim sorts.Product: In home use, controlled store tests, test market pricing, color and taste tests.Communication: Copy testing, packaging, eye tracking and name tests.Category and market: Market segmentation and market structure.Tracking: Awareness and usage, advertising and equity.Panel: Syndicated and custom diaries.Multicultural: Hispanic custom and syndicated studies and retail p...

Adhesives and Thin Films Consultant with expertise in Scale-Up, New Product Development, Market and AnalysisIndustrial applications development, market analysis, scale up, for thin film adhesives industry.Market analysis and development of structural adhesives.New product introduction, film adhesives: Electronics, construction, medical device, renewable energy.Six sigma and design for six sigma certified.Thin film and die cutting process web handlingThin film process development: Extrusion, UV-curing, and solvent.Reaction Injection Molding (RIM) process development: Moisture curing urethane adhesives.Expert Witness ExperienceIntellectual p...

Thermoset Chemistry and Material Composites (Eepoxy, Phenolic, Cyanate Ester, Benzoxazine, Vinyl Ester, Polyester, Polyurethane, Polyimides) Development and Manufacturing ExpertPolymer matrix formulation for composites (autoclave cured, VBO, RTM, VaRTM, FW, Press-cure).Thermoset chemistry (epoxy, phenolic, cyanate ester, benzoxazine, vinyl ester, polyester, polyurethane, polyimides).Chemical, thermal, mechanical and physical characterization.Product development and qualification process (project management, stage/gate, timeline, financing).Quality process (Root cause analysis, AS9100C manufacturing environment, SPC, DOE, Six Sigma)Markets...