Expert in the Design, Operation, Optimization, and Troubleshooting of FCC Units, with a Focus on Maximizing Unit Performance and ProfitabilityOver Thirty years of experience in process engineering in the petroleum refining industry, based on a long-term career with ExxonMobil Research and Engineering Company.Focused on fluidized bed catalytic cracking unit (FCCU) design, start-up, operations, troubleshooting, and optimization.Undisclosed Company, Senior Advisor, PresentProviding consulting in the FCC...

Very Experienced Chemical Engineer for Polymers and Elastomer Plant Design and Operations Expert in Polymer DevolatilizationSummaryOver 25 years of chemical engineering experience in the polymer and chemical industries. Proven ability to commercialize new products and processes in a cost-effective and schedule-driven manner. Engineering work includes process concept, pilot plant, plant design, construction, operator training and start-up and commercial operation. Broad development, chemical engineering, manufacturing base in plastics, elastomers and chemicals.Specific ExpertiseChemical engineering technology development.Pilot plant desi...

Laboratories Applications, Pilot and Production Size Testing within a Wide Variety of Mixing, Granulating, Pelletizing Technologies, Particle Size Reduction and Classification TechnologiesMaterials processing technology knowledgeGranulation expert, experience in over 300 industries.Laboratory pilot and production size testing using, a wide variety of mixing, granulating, pelletizing technologies, particle size reduction and classification technologies, drying and calcining technologies, and material conveying and feeding technologies.Maximizer-devise ways to measure performance, investigate the cause and effect relationships in processing...

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...

Leading Product Creation Though CE/FDA Submission, ISO, MDSAP Audit, R&D Documents (DHF): DI, DO, Risk, V&V plan, Protocols and Reports. Quality Procedures Implantation, Quality & Regulatory BinderAssurance, Quality Control, and Regulatory Affairs Manage and establish total quality system according to EN ISO 13485:2016, MDD/MDR Requirements and QSR (21 CFR 820). CE ( European Certification) certificated from technical documentation preparation through submission and external audit by notified bodies. Other countries certificates: Japan (including on-site audit), Korea, Canada, Australia, India with special requirements of different...

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.

Worldwide Pharmaceutical Expert Providing: Coordination and Technology of Pharmaceutical Products and Formulation and Development of Solids and ParenteralsSummaryExpertise in global product development, technology transfer/validation and business development.Designed and implemented development and registration strategies in U.S. and International arenas.Significant experience with all pharmaceutical dosage forms including peptides and novel delivery systems.Expert WitnessTwenty years of experience as an expert witness for pharmaceutical and formulation matters.