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...

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...

Doctorate in Biochemistry Experience in Academics, Biomedical Research, Process Development (Upstream and Downstream) of Bacterial Vaccines and Protein Therapeutics for Scale Up to ManufacturingIndustrial Biotechnology  Biotechnology facility design and layout, overall planning, project conception, budgeting and execution.  Over twenty tears of industrial experience in-process development of vaccines and biologicals in leading companies.   Research and development biotechnology management and transfer. Process development and optimization for bacterial vaccines.  Vaccine’s manufacturing unit layout an...

Providing Diagnostics in Blood Collection Platforms, Develop Control Sensors and Instrumentation for the Pulp & Paper, Plastics Industries, Commercializing New Infrared & X-ray Sensor Technology. Accomplished senior research and development leader, Ph.D. in physics, executing extensive experience in new product development, and focus in optical and medical devices and diagnostics. Targeting customer needs, assessing new technologies, and developing innovative business and technology opportunities. With both Fortune 500 and entrepreneurial, and startup company experience, bringing dynamic leadership and technical expertise to instrume...

Senior Mechanical Engineer and Procurement Professional with Rich Experience in Oil/Gas Pipelines, Upstream and Unconventional Upstream Gas Projects in the GCC Region, On-Time Deliveries to Project SiSummary Supply Chain Management, (SCM), domain with skills in procurement, contracts, construction, systems, project and  general management, contributing to the growth of the organization.. Oil and Gas Project management Project Procurement Management Purchasing for oil/gas EPC projects Supply chain for oil/gas projects Budgeting and Cost Control Warehousing Management Equipment Preservation Techniques Equipment Condition Moni...

Business & Academic Environments- Production & Operational Teams, Building B2B Industrial Companies in Plastics, Life Sciences Industries, and ISO 9001 AuditorSummary  Chief Technologist with the successful execution of production and operational teams in business and academic environments. Developed materials and products for B2B industrial companies, in plastics and life sciences industries. Deploying over 15 years of experience in processing plastics, chemicals, and downstream products including films and medical devices.  Author, composing and presenting, scientific papers, grant applications, Patent Inventor, and patent b...

Expert in Polymers, Plastics, Materials, Plastics & Adhesives; Solving Challenging Industry Problems Resulting in Sales Exceeding $2 Billion.Summary Ph.D. Chemist, Scientist and Executive in chemical and polymer industries with broad a range of experience including research and development, intellectual property, manufacturing, and business development. Specific focus to polymers, plastics, materials, composites, adhesives, coatings, and failure analysis. Providing over 30 years of industrial experience as a Scientist, R&D Manager, Director of Research and Development, Chief Technology Officer, and Director of Manufacturing with the...

OTD/Occupational Therapy and Psychiatric Industry Writing and Author, including the Legal SectorRegulatory Medical Writing Clinical Medical Writing Editing Quality Control Business Development Expert Witness Experience Writing Experience (Phases 1, 2, 3, and 4): Wrote and edited ICH-compliant documents, including investigator brochures (IBs); Investigational New Drug (IND) applications. Marketing Authorization Application (MAA); informed consent documents (ICF); protocols and amendments. Clinical trial agreements (CTAs); clinical study reports (CSRs). Clinical evaluation reports (CERs); biologics license applications (BLA);...

Chemical Process and Catalyst Technology Evaluation, Licensing, Patent Analysis, Sales and Marketing, Mergers & Acquisitions, Market Studies, & Strategic PlanningCatalyst and Process Technologies ProductionAcetic acid and acetic anhydride.1,4-butanediol, tetrahydrofuran and gamma butyrolactone.n-butanol and isobutanol, n-butyraldehyde, isobutyraldehyde, 2-ethylhexanol.Carbon dioxide and carbon monoxide.Ethylene, ethylene oxide, ethylene glycols, ethylene glycol ethers, ethanolamines, ethyleneamines, ethoxylates, and polyetherpolyols..Formaldehyde and formic acid.Hydrogen and hydrogen peroxide.Maleic anhydride and phthalic anhydride.Methyl...