Pharmaceutical Quality Assurance Quality Control expert with experience with U.S., E.U., Canada, and India regulationsPharmaceutical Quality Assurance and Regulatory Affairs.Compliance audit, Quality Operations and Regulatory Submissions.Design and implementation of Quality Systems and regulatory compliance programs.Domestic and international quality and regulatory compliance.Managing contract / vendor supply chain quality programs.Developing and delivering GMP, GDP, DI procedure training programs.Leading the Quality efforts to successfully remediate recurring failures.Generation, maintenance and revision of SOP's, specifications, procedur...

Medicinal Chemist Consultant for API Process Research, Development and API Process Start-upSynthetic organic chemist and small scale chemical process research and development.Chemical process research and development for "small molecule" drug substances.Guidance for scale-up to provide material for Phases 1 - 3 and manufacturing.Pharmaceutical facility start-up troubleshooting.Assistance with CMC section of filings.Pharmaceutical laboratory process research leading to technology transfer and scale up.Design and implementation of practical, cost-saving, processes and procedures.Experienced with 12 hands-on manufacturing start-ups of drug su...

Expert in analysis of chemicals and pharmaceutical, specializing in chiral chemistry.35 years of experience in analytical chemistry for chemical, pharmaceutical, environmental and polymers.Experience in wet chemistry and instrumental analysis.In depth knowledge of chromatographic (HPLC, GC, CE and GPC) techniques.Chiral chromatography.Skilled at reversed-phase, normal phase and chiral methods development with short turn around time.Chiral and achiral methods development for starting materials, intermediates and products.Analysis of starting materials, intermediates, API and products.Analysis of polymer materials and constituent ingredients...

Water Soluble Polymer Excipents Consultant for Pharmaceutical Dosage FormsFormulation and process development, scale-up, technology transfer and production troubleshooting of pharmaceutical oral solid dosage forms.Extensive experience as a supplier of water soluble polymers to the pharmaceutical industry.Excipient business development and technical service.Expert on water soluble cellulose ethers, wet granulation for sustained release and related drug formulations.Use of water soluble polymers in granulation, film coating and sustained release matrix formulation.Regulatory compliance work on pharmaceutical companies operating under a conse...

Pharmaceutical Drug Development Expert: Scale-up, Technology Transfer, Process Optimization, Troubleshooting, Clinical Supplies, FDA and ICH Quality and ComplianceManaging pharmaceutical operations, process and analytical methods development.New pharmaceutical product formulation development, scale-up, process start-up, optimization and troubleshooting.FDA-recognized expert in formulation development and technology transfer.Pharmaceutical licensing, Regulatory Affairs (CMC), quality systems and staff management.

Pharmaceutic Analytical Chemistry Consultant Expert in Drug Stability and Identification of API and Chemical Materials, (Pharmaceutical Chemist Expert on Forced API Degradation Studies and Drug Stability)Leadership of multi-scientist group responsible for the analytical characterization of drug substance and drug product formulations.Analytical method development and validation, drug substance and drug product characterization, stability evaluation, and analytical research and development project management.Broad background in the areas of physical-organic chemistry and analytical chemistry, chromatographic (HPLC, GC, SEC, Chiral) and spe...

Pharmaceutical Formulation Development and Process Development ScientistPharmaceutical formulation development and process transfer, serving over twenty five years' in the pharmaceutical industry.Develop products; solid dosages, liquids, capsules, research new technologies, and sustained release technologies.Experience with formulation, validation and scale up of all the above named disciplines.Supervisor and Manager responsible for staff consisting of formulators, packaging engineers, and equipment engineers.Clinical supply manufacturing and troubleshooting processes with successful transfer to process engineering and then to manufacturin...

Protein Chemistry Consultant Specializing in Protein Purification, Characterization, Analysis, Research and Protein DevelopmentDeveloped novel procedures for purification of proteins from recombinant sources including: bacteria, yeast, mammalian cells and viral expression systems.Purified recombinant proteins containing affinity tags such as six-histidine and glutathione transferase; published new procedure for purification of c-myc tagged proteins by immuno-affinity chromatography.Large-scale production of native proteins from animal tissue and blood products.Developed two commercial products for clinical diagnostics market.Isolated and...

Functional properties of IgA. Development of oral vaccine delivery technologies. Effectiveness of host-parasite relationships. Mechanisms of adherence and pathogenisis. Development of oral drug delivery systems. Development of biodegradable nanoparticles, tumor targeting agents, transdermal drug delivery systems, and oral nanolattices for protein drugs.Functional properties of IgA.Development of oral vaccine delivery technologies.Effectiveness of host-parasite relationships.Mechanisms of adherence and pathogenisis.Transport of macromolecules across the intestinal epithelium.Receptor mediated endocytosis.Isolation, purification and refoldi...

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...