Doctorate in Environmental and Occupational Health (with dual certification, Industrial Hygienist (CIH) and a Certified Safety Professional). in Pharmaceutical Exposure-Control, Exposure Assessment Strategies, Analysis of Industrial Hygiene Data, Ventilation Engineering and Indoor Air QualityIndustrial Hygienist (CIH).Certified Safety Professional - air quality evaluations, noise analysis, and safety programs.Exposure assessment.Analysis of industrial hygiene and exposure data.Pharmaceutical exposure control.Local exhaust ventilation.Indoor air quality.

Seasoned engineer in pharmaceutical, biotechnology and medical devices manufacturing capital projects, processes and facilities compliant with GMP, FDA and ISO requirements.Capital project implementation, in GMP, FDA and ISO environments through design, construction, commissioning, validation of manufacturing facilities, processes, equipment, and multi-tasking.Oversight of project, process, plant, facilities engineering and architecture and engineering contractors.Engineering support to identify, troubleshoot problems and provide a cost effective solution to maintain and increase productivity.Strategic planning leadership for process impro...

IT Business Consulting Providing Project Management and Functional Consultant Expertise: Cloud-Based Software Solutions Understanding Manufacturing, Implemented Production Planning Solutions-Capacity Summary Accomplished, innovative, hands-on, executive-level consultant with excellent leadership ability and over thirty-five-year track record of consistent value add and continuous improvement activities in the areas of Information Technology domestically and globally. A strong suite of skills that includes hands-on experience in delivering business-driven, strategic technology solutions, enterprise architectures, business integration, o...

Ph.D. Technology Expert, Industrial Leader, Transforming Companies in Producing Innovative Products, Novel Product Concepts, and Product Development ConsultingNew business and technology expert, aligning company competencies to customer needs through deep technical proficiency. Proven Industrial leader, impactfully helping companies transform ideas into innovative products through: Understanding market conditions, building trusting customers relationships, brainstorming novel product concepts, and supporting product development. Specific Disciplines Photonics Optical communications Intellectual property  Technical portfoli...

Ph.D. Legal Consultant, Providing Various Expert Support in: FDA Approvals, Evaluations-Patents Medical Devices and Drugs, Data Integrity and Software Development, Author and Expert Report Writings.  Regulatory, Food and Drug Administration (FDA)-related provisions and cases providing support to legal clients in areas: Death or injury caused by drugs, biologics or medical devices, (patents, insurance claims, wrongful termination, trade secrets, merger and acquisitions. Develop and present more than 40 FDA related technical, regulatory and compliance topics to over 50,000 participants. Depositions. Develop case-specific informat...

Expert in acrylic emulsion polymerization chemical engineering, ink jet and pigment dispersion and coating rheology.Emulsion polymerization, process development, scale up, process control and steam stripping.Emulsion polymerization operational excellence.Effect of mixing and process variables on polymerization process.Quality, SPC, productivity, process safety of emulsion polymerization processes.Ultra low VOV latex.Intellectual Properties (IP) landscape mapping, new process pipeline initiative.China joint venture (equipments modification, technology transfer, startup the new plant, training, raw material qualification, QC).Continuously po...

Toxicology Consultant Specializing in Inhalation, In Vitro and High Content Screening, Consumer Product Additives, Tissue Regeneration Research, Cancer Cell Biology, Nutrition Research, Preclinical, Experimental Design and AnalysisPreclinical toxicology of consumer products. Design and manage external toxicity studies and summarize study reports. Research on natural compounds and cancer reversion, and toxin induced pathways involved in disease. Inhalation, reproductive, and in vitro toxicology. High content screening assays and new in vitro toxicology assay development. Proof-of-concept for new products, and regulatory toxicology (F...

Petrochemical Engineer Operations Manager Specializing in Facility Assessments, Operations, EH&S Practices. Expert Knowledge in Risk Reduction and Refinery Safety Management ProgramsRefinery safety management systems evaluation and recommendations.Fire and explosion investigations.Emergency response planning.Petrochemical operations and troubleshooting.Evaluations of refinery EH&S (Environmental Health and Safety) procedures and practices.Process improvement projects for refinery operations, EH&S practices.Improving petrochemical industry and regulatory agencies communication.Expert Witness ExperienceRefinery and petrochemical process oper...

Pharmaceutical Regulatory Affairs Consulting in: Project Management, Quality and Compliance - NDA, ANDA, DMF and eCTD - Domestic and InternationalHigh-performing Regulatory Affairs and Compliance Professional with over 25 years of diverse pharmaceutical experience in sterile injectable, solid dosage, oral solution, and inhalation product environments. Demonstrated knowledge of regulations and the NDA/ANDA/DMF eCTD submission process with a successful track record in obtaining over 200 drug product approvals. Proven expertise in negotiating effectively with the U.S. FDA applying broad understanding and experience in handling p...

Ph.D. Metallurgist with Expertise in the Oil and Gas Industry: Regulatory Compliance, Corrosion and Management, International Standards-Implications on HSE and Regulatory Requirements.Oil and gas operations oversite, risk corrosion and H2S management technologist. Materials specialist for the oil and gas industries. Energy alloys providing technical services in metallurgy and materials worldwide. Sour services (H2S, hydrogen sulphide) and technical support, domestic and abroad. Asset Integrity Management specialist in the oil and gas industry. Metallurgist with proven record in the oil and gas industry. Corrosion specialist servici...