Pharmaceutical Technical Operations Executive Specializing in Drug Development and OperationsPharmaceutical chemistry manufacturing and control.Small virtual pharmaceutical manufacturing.Materials management and control.Pharmaceutical quality assurance.Technical services.Undisclosed Company, Managing Principal, 2010 - PresentProvide service to virtual pharmaceutical and biotechnology industry in the areas of supply chain, manufacturing, project management, quality and compliance.ProjectsLed CMC development team for a Phase I/II small molecule progr...

Development and Implementation of Phase-Specific Quality Systems and Pharmaceutical Production and TestingPharmaceutical quality assurance management and corporate quality strategy planning.Development and implementation of phase-specific quality systemsIdentifying and correcting road blocks to efficiency and complianceGMP facility design, construction management, validation and licensing of GMP manufacturing facilities.Proven success in U.S. and E.U Inspections of manufacturing and laboratories.Over 20 years of valuable experience developing and managing highly productive work groups in small to mid-size pharmaceutical.

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...

Drug Stability, Pharmaceutical Impurities, and Control Strategies ExpertChemical, physical, and environmental stability and degradation.Preformulation, formulation design and stability.Analytical and impurity (including mutagenic impurity) control strategies, including structure elucidation, characterization, predictive technologies and risk assessment.Photostability, photochemistry and photostabilization.Regulatory issues and authoring, primarily chemistry, manufacturing and controls section.Expert Witness ExperiencePatent case in Europe, regarding differences in stability between prasugrel and clopidogrel, and testified as Expert Witnes...

Dietary Supplement and Functional Food Consultant Specializing in NPD Innovation and Quality/GMP ComplianceNatural product development and formulation; vet new product opportunities: Navigating IP infringement avoidance, scientific validation, efficacy, dosage, market viability, and regulatory compliance.Natural product ingredient assessments, technical review, and scientific approval.Provide marketing content, direction and guidance for new product launch.New product positioning and marketing strategy, product naming and tag line creation.Natural product: Product quality and marketing integrity: IP protection, regulatory compliance and...

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...

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...

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...

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...

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...