Pharmaceutical Chemist and Former FDA Manager GMC, FDA Compliance and Expert WitnessRegulatoryFood and Drug Administration compliance.Prepare submissions to the Food and Drug Administration.Quality audits and implementation of changes.Simulated FDA inspection - quality and readiness audits.Establish and review quality assurance procedures for GMP and GLP.Develop and write appropriate Standard Operating Procedures (SOPs).Assist firms with Consent Decrees, Warning Letters, and 483s.Chemistry, Manufacturing, and Controls (CMC) expert.TechnicalLaboratory procedures and documentation.Pharmaceutical package and labeling and product compatibility...

Expert in new business development & startup, marketing research, pricing & value analysis, product penetration modeling, fluoropolymers, engineering plasticsTiO2 products and markets.Advanced ceramic materials, tough ceramic composites and ceramic parts.Fluoropolymer materials, films and devices.Competitive product assessment; product and capital financial analysis.Business strategy development; team building.New business development and start-up.Marketing research, pricing and value analysis.Intellectual property and product valuation.Technology/product penetration modeling.Idea generation and group creativity.

Business development & marketing of pharmaceutical, biotech, and chemical products specializing in contracts, equity investments, research agreements, customer supplly arrangements, technology acquisition, sales, & marketing.PharmaceuticalBiotechChemicalContracts & equity investmentsEnzyme developmentAntibiotic improvementBiopolymer intermediateGenomic based proteins for CNS drug targetsIsoprenoid platformAnimal feed -...

Photopolymer consultant specializing in optoelectronic technology, digital printing and imaging and new business development for optoelectronic devices and materials.Photopolymer consultant for for optical communications and digital printing and imaging.Acquisition strategy and indepth due diligence experience for acquisition of optical materials and optical device new businesses and technology.Consultant for flexographic printing, printing plates, photo resists and overall imaging technology.Expert witness on technology issues related to optoelectronics, photopolymers, lasers and related business arrangements.

Pharmaceutical exicpients and fine chemical marketing and technical expert.Over 20 years' experience working in specialty chemicals, biotechnology, food and consulting with broad experience in project management, new business development, intellectual property commercialization and licensing, strategic planning, marketing research, business analysis and merger and acquisition. International experience working with French business leaders in the major industrial sectors while living in France. Specific expertise in:Pharmaceutical ExcipientsRare Earth/Gallium MarketsSilicate MarketNew Business/New Venture EvaluationMarket Research & Strate...

Retired executive expert in specialty and fine chemical markets and technology transfer.Senior executive with broad international experience, including over 25 years in the chemical and related industries.Technology assessment, global management, commercial development.Strong Experience with international business management, commercial development and strategic planning.Technology focusing and transfer.Cross-cultural Development.Unique management experience in bio/fine specialties for major European chemical manufacturers.International management experience working and living in France, Japan, the Netherlands, Russia, and the United State...

Competitive analysis, benchmarking, market and industry analysis, due diligence and management counsel. Numerous business research studies for companies interested in companies, products, channels of distribution, and industry trends and forecasts.Technical marketing research: Demand, supply, pricing, competitive assessment product attribute measurement and valuation.Competitive analysis, benchmarking, market and industry analysis, due diligence and management counsel.Conducted many market/business research studies for companies interested in acquisitions, new product development, product pricing, channels of distribution and industry tr...

Intellectual property strategist and technology valuation expertTechnology licensing, particularly chemicals and polymers.Negotiations associated with technology licensing.Trademark licensing programs.Development of strategies to beneficially use patent estate to satisfy Federal regulations.Development of and support for historic corporate IP donation programs.Kevlar;® and Nomex;® aramid fiber applications technology and business development.Independent Consultant, 2004 - PresentMaintained a leadership role and generated target revenues in licensing selected polymeri...

Expert and Consultant on Green-Fluorescent Protein: Isolation, Assay Development and Biochemistry of Bioluminescence and Luminescent SystemsGreen-fluorescent protein (GFP): isolation and characterizationMarine bioluminescenceElectrophoresisGFP in HTS assay developmentBiochemistry of luminescent systemsProtein and peptide chemistry including isolation and purificationBatch methods of protein purification such as tangential flow ultra filtration and three-phase partitioning.Protein photoinactivationHPLCBioluminescent genetic assay developmentProtease assay developmentAssay design and diagnostics kits.

Pharmaceutical management, manufacturing in China, supply chain expertise and coordinating major capital projects, new product introduction and new business development.Pharmaceutical technical operations with diverse international experience.Pharmaceutical management, manufacturing, supply chain, major capital projects, new product introduction and business development, with a focus on China.Particular expertise in operating at strategic levels in international and multicultural environments.Capital project management, site selection and team leadership.cGMP, regulatory affairs and compliance experience.