Ph.D. Biochemist Specializing in Protein Purification and CharacterizationProtein purification and refolding.NMR and Crystallography protein purification using LC-MS to characterize proteins.Over 40 years of industry experience in drug developmentCurrent GMPSpecializing in developing new and very effective purification methods.Specializing in assay development.Purification of human insulin and Insulin analogs.Human monocyte/neutrophil elastase inhibitor, developed the expression of MNEI in E coli.Undisclosed Company, President and Founder, 2006 - 2013Acquired facilit...

Ph.D. Synthetic Organic and Analytical Chemist skilled in FT-NMR, FT-IR, UV/Vis and Mass Spectrometric Methods for Purification and Separation Organic CompoundsStructural characterization and qualification of pharmaceutical API's, intermediates and metabolites using both 1H and 13C-NMR.Deformulation analysis of generic and pharmaceutical products.Stereospecific of chirally pure herbicides and fungicides.Facile synthesis of a series of novel Class II Mesoionic Xanthine Acyclonucleosides.Purine nucleoside analogs.Synthetic method for the preparation of the Dopamine-1 receptor antagonists SKF-85366 and SCH-23390.Synthesis of 18F-Spiperone a...

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...

Pharmaceutical Manufacturing Production Consultant in QA/QC, GMP, Root Cause Analysis, Non-Conformance (NOE) InvestigationsPharmaceutical industry Good Manufacturing Practices, (GMP) and ISO Standards.Ability to manage multicultural environments, motivate staff members and implement company objectives.Diverse manufacturing and compliance activities.TPS tools, Lean, Six Sigma and Toyota Kata.Latin America experienced. Bilingual, Spanish and English.Undisclosed Company, Manufacturing - Quality, 2014 - 2015Director of O...

Pharmaceutical API and QA Consultant with Expertise in Steroids and Norsteroids Manufacturing. Lean Management, Validation, FDA InspectionsActive Pharmaceutical Ingredient (API) manufacturing and quality assurance, successful scale-up, technology transfer and quality assurance projects.Steroid plant operations; training, FDA inspections, and manufacturing.Lean management in API manufacturing.Quality assurance management; release operations in packaging processesAPI manufacturing - steroids and norsteroids.Pharmaceutical products scale-ups and technology transfers.Qualification of equipment (reactors, centrifuge, dryers etc.) and utilities,...

Ph.D Pharmaceutical Regulatory and Laboratory Compliance, Quality Assurance and Controls (cGMP, FDA, ICH, EMA, ISO) ConsultantPharmaceutical and biotechnology product development, management of cGMP compliance quality systems, quality control, quality assurance, (in unique dosage forms, and sterile-nonsterile processing methods).Laboratory quality systems for both pharmaceutical development and quality control testing.Complete laboratory outfitting including qualification and method implementation.Test method development, transfer and validation.Analytical measurement and techniques.Auditing systems and processes.Analysis of APIs, raw mate...

Ph.D. Consultant with expertise in Characterization and Quantitation of Proteins and Small Molecules. Subject Matter Expert (SME), Oversight (in-house-external) CRO support, and GLP/GMP.Analytical and bioanalytical methods for characterization and quantitation of drug therapeutics and pharmaceutical product development.Monitor analytical and bioanalytical activities at CROs in support of non-clinical and clinical trials.Characterization of small molecule, biologics (peptides, proteins, and antibodies), antibody drugs conjugates (ADCs), PEGylated proteins, and oligonucleotides.Drug Metabolism and Pharmacokinetics (DMP) parameters, basic no...

Pharmaceutical Operations - Small to Mid-Sized Companies, from Technology Transfer through Packaging and Distribution, and with Companies Under Regulatory or Financial DuressLife sciences manufacturing with specific focus to technology services, quality systems, engineering oversite, strategic and tactical planning strategies.Providing supply chain consulting and compliance achieving profitability goals, utilizing Lean Six Sigma.ServicesLean Six Sigma Black Belt.Pharmaceutical manufacturing.Pharmaceutical process engineering.Pharmaceutical continuous improvement.Quality engineering and quality systems.Quality Systems Implementation.Cont...

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...

Senior Pharma Regulatory Consultant with Expertise in Strategic Planning, Development, US Regulatory Preparation, Documentation (IND ANDA, DMF, CTD) and Quality AssuranceExpediting pharmaceutical services in: Pharmaceutical regulatory, Quality Assurance (QA), global pharmaceutical support, investigational and drug development.Enhancement and development of regulatory affairs with an overall development of regulatory strategy for business models through evaluation and control of pipeline products for commercial and drug development venture companies.Building pharmaceutical regulatory departments and assessing their effectiveness in paralle...