Medical Device Consultant with Broad Experience in Business Management, R&D, and Regulatory Compliance: FDA, ISO, CEMedical device product development, market positioning, strategic planning, and branding strategy.Regulatory affairs and compliance, (FDA, ISO and CE approval processes).Technology leader providing equivalent support for the health care, security, intellectual property, and space industries while successfully developing new businesses in the U.S. and abroad.Budget and resource management, contract management and negotiation, change management and restructuring, profit and loss accountability, forecasting and trend analysis,...

Global Marketing Expert for fluorochemicals Surfactants, Protectants, and IntermediatesGlobal technical marketing and sales of fluorochemical products.New market development.Specialty chemicals product launch - through stage gate process.Marketing strategy and execution.Fluorosurfactants, Fluoroprotectants, Fluorointermediates marketing.Independent Consultant, PresentDuPont, Wilmington, DE, 1995 - 2013Business Development Manager - Solutions Architect, 2011 - 2013Developed consulting based solutions for client businesses in oil and gas, mining, and manuf...

Coating Expert for Products in Textiles, Paper, Stone Floor Products Derived from Fluorosurfactants, Fluoroprotectants, FluoroalcoholsSynthetic organic chemistry, organo-fluorine, polymer chemistry, hydroboration, reduction, hydrocyanation, and diazonium chemistry.Fluorosurfactants, fluoroprotectants, fluoroalcohols, chemical processing of fluoroiodide through alcohol to finished products.Development of emulsion fluoropolymers used for coating products for textiles, paper, stone and floor products.Development of small molecule fluoro products such as surfactants for paints.Product development from products downstream of TFE.Six Sigma Bl...

International agricultural policies and guidelines related to crop production and protection, with specific crops: Bast fibers, cereals, food legumes, tubers, roots and seed spices.Plant Pathologist: Breeder and seed specialist for wheat, barley, food legumes, millets, sorghum, rice, corn and bast fiber crops.Project Implantation Manager: Strategic planning for resources and time, monitoring and evaluation of projects for research and development.Production and dissemination of rhizome improved varieties and generated new crop and rhizome production technology.Cassava and sweet potato germplasm evaluation and raising of tissue culture pl...

National-International Therapeutic Expert Focused on Inflammation/Autoimmune Disease, Transplantation, Respiratory Diseases, Infectious Diseases, Vaccines, Diagnostics, and Oncology.Strategy and streamlined processes for the identification and evaluation of strategic partnerships.Ability to obtain alignment, prioritize and build consensus from internal stakeholders.Diverse therapeutic area expertise in both global and U.S. markets, including; inflammation/autoimmune disease, transplantation, respiratory diseases, infectious diseases, vaccines, diagnostics, and oncology.Academic collaborations, technologies, early and late stage products, p...

Fermentation Expert in Compliance Activities, FDA API Manufacturing (US and European sites) Commercialization, FSMA PCQ1 trainer, Development of Procedures Laboratory Methodology and TrainingRegulatory support for organizations dealing with new product approvals and introduction, expanding operations, technology transfer, and changing customer, regulatory or certification requirements.FSMA (Food Safety Modernization Act) compliance in regulatory analysis, strategies and meeting deadlines.FSPCA Lead Instructor (Human Foods Certified and Animal Foods Certified), providing PCQI training to industry and regulatory agencies, including FDA.Preve...

Materials Science Engineering Consultant Specializing in Development, Testing, Certification and Inspection of Composite Materials and Processes for Aircraft Applications.Composite material characterization, optimization, testing and certification.Manufacturing process development and quality control.Surface preparation and structural bonding of composite structures.Flammability testing of aircraft interiors.Advanced composites, adhesives, sealants, and paints for aerospace applications.Carbon and glass epoxy prepreg selection, characterization and application.Composite destructive and nondestructive inspection development: ultrasonic insp...

Biomedical Sciences PhD Consultant specializing in Gene Therapy, Virology, ProteomicsVirologyOncologyDNA repair and recombinationDNA replicationProtein-DNA interactionsProtein-protein interactionsProteomicsQuantitative-Polymerase Chain Reaction, (PCR)Allele specific-PCRAntibody production-generationImmunofluorescenceImmunoblotingCell biologyCancer biologyMolecular biologyYeast geneticsGene therapyRecombinasesSite directed gene modifications.Cloning, protein expression and protein purification.Trained in various techniques routinely used in biochemistry.Ind...

Medical Device Consultant Specializing in Materials, Design, Test Method Development, Product Development, Quality System Regulations, Process Validation, Supplier Qualification, ISO, FDA and REACH Compliance. Medical Device Process Validation Consultant, Supplier Qualification, ISO, FDA and REACH compliance.Product development from concept to market.21CFR820 (cGMP) and ISO13485 QSR.Polymers and materials for medical devices.Vascular and catheter systems.DOEs and process optimization.Process Validation (IQ, OQ, PQ).Medical device design control process.EPA, FDA, REACH and RoHS compliance regulations.Fluoropolymer and lubricious coating com...

Chemical Market Assessment and Strategy Development; Company Assessment, Workshops and Trainings Specific to ChinaChemical industry in China.Merger and acquisitions, target search in the chemical industry, particularly China.Strategy development in the chemical industry in China.Market trends in chemical industry in China.Research and development optimization in chemical industry.Expert Witness ExperienceLegal matter in merger and acquisitions.Legal matter in development of China chemical industry strategy.Undisclosed Company,...