Interpretation and Analysis of Technical Intellectual Property Related Documents in English and Japanese. Biochemistry and Cellular Biology Background in Biologics and Small Molecule Drug Discovery and Development. Drug Substance In Vitro Assay Development and StandardizationInterpretation and analysis of highly technical Japanese documents in English.Pharmaceutical and biotechnology research project management.Biochemistry - cellular biology background: Biologics and small molecule drug discovery and development.Liaison and interpreter for licensing and material transfers to and from Japanese organization.Manager of in vitro pharmacol...

Pharmaceutical Dosage Form Process Engineer: Spray Congealing, Spray Drying, Fluid Bed Coating and Fluid Bed GranulationPharmaceutical process and product development.Design and development of unusual and novel pharmaceutical processes and dosage forms.Extensive experience from initial process development to commercialization.Process evaluation - process design, develop, scale-up, robustness, troubleshooting.Mass Transport and unit operations.Extensive experience in unit operations in pharmaceutical processing development to commercialization:GranulationCompressionExtrusion (melt extrusion and continuous granulation)Spray congealingSpray...

Bioprocess Engineering in Technology Transfer, GMP Manufacturing, Scale-Up, FMEA, CAPA for the Pharmaceutical IndustryBioprocess engineering specific to equipment (equipment reliability and maintenance), systems and facilities.Bioprocess validation (aseptic processes, equipment, systems, facilities and cleaning).Technological process scale-up from bench top to pilot and commercial manufacturing.Biological active compounds and nanoparticle based drug delivery systems.cGMP manufacturing of pharmaceutical and biopharmaceutical products.Technology transfer to a Contract Manufacturing Organization (CMO) in Canada and U.S.A.Documentation review...

Former FDA Investigator - Expert in Regulations, Interpretations, Medical Devices, and Dietary Supplements.Former FDA Investigator.Technical writing to build and implement quality systems.Comprehensive audit and gap analysis.CAPA and FDA responses and complaints including: Investigations, resolution, root cause analysis, corrective action plans, preventative action plans and CAPA effectiveness resolution and documentation.Employee training; laboratory and quality.Formal FDA Training in multiple program areas: Drugs; medical devices; process validation; industrial sterilization; biologics; dietary supplements; food and feed.Ability to audit...

A Creative Scientist with Proven, Leadership & Business Skills. Extensive Contributions to Top Brands for Fortune 10 Food Companies. Venture Capital Skills in all Phases of Business and Scientific AOrganic Chemist: Trained with deep knowledge and experience in nearly all food systems and technologies. Proficient in food chemistry, thermal analysis, statistical experimental design, polymer chemistry, food microstructure and all food macromolecules. Developed and taught curriculum on water in foods, coating technology, starch and hydrocolloids. Food Product Creator: Baked goods, beverages, teas, snacks, cereals, bars, nutritional supple...

Pharmaceutical Analytical Chemistry Consultant Specializing in Method Development, Method Validation, Cleaning Validation and Verification, Drug Stability and cGMP, FDA and ICH Quality and Compliance.Analytical method development and method validation for small molecule pharmaceuticals.Cleaning validations and cleaning verifications.OOS (Out of Specification) and OOT (Out of Trend) investigations.Stability management.Setting specifications for finished products and API.Project management for CROs (Contract Research Organizations).Formulation development support.Pharmaceutical quality control.Protocol and SOP (Standard Operating Procedures...

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...

Lab Testing Design: Drugs-Pharmaceutical Testing, Lab Operations, Maintenance, and Quality Control of Drug Testing Labs: Toxicology, Cannabis, Bioequivalence), Regulatory Requirements, BioequivalencSummary Over 17 years of drug testing experience on the development, validation, and application of analytical methods.  Equal experience in drug testing Labs design, operation, maintenance, and quality control of drug testing labs: Toxicology, cannabis, drugs, bioequivalence), cannabis regulatory requirements, bioequivalence studies, quality control studies, analytical laboratories’ quality assurance procedures.&n...