Biological Manufacturing: Auditing, Root Cause Analysis, Corrective, Preventative Action and GxP compliance. Biological and clinical manufacturing operations executive, providing a wide range of experience in quality leadership across many facets. Create, develop and recommend program and system changes pertaining to vaccine product release and deviation management resulting in more efficient product release to market and improved "right-first-time" manufacturing metric. Articulate leader with unparalleled work ethic coupled with a strong sense of urgency, keen interest and passion in making quality a key ingredient to the success of...

Commissioning and Qualification of Solid Oral Dosage Facilities, Operation Excellence in Supply Chain, Drug Master Files Review, Validation of Analytic Control, Implement EHS Management Systems Quality management system: Design, Standard Operating Procedures (SOP) training, auditing, upgrading quality systems. Design of oral dosage manufacturing processes. Design of manufacturing process and equipment’s User Requirement Specification (URS). Commissioning and qualification of process equipment, clean rooms, HVAC, and purified water system. Market research, business plan, product targeting. Regulatory affairs: Review of parts 1...

Specialty Chemicals & Pharmaceutical Supply Chain-Change Agent, Regulatory, EPA, OSHA-PSM and Global Manufacturing ExpertPharmaceutical and specialty chemical operations with 20 years’ in supply chain Leadership for large facilities, providing technical solutions in challenging environments in union and non-union members. Manufacturing and operations professional, action-oriented, building effective teams and delivering positive results with unlimited drive for continuous improvement in fast paced, global businesses. Change agent and transformative leader in global manufacturing footprints leading to increased efficiency and throughp...

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...

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...

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...

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...