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Pharmaceutical Science; Preformulating, Development, Chemistry, Manufacturing & Control (CMC) Issues; Paragraph IV Hatch-Waxman & Canadian Notice of Allegation
As the development of a pharmaceutical reaches Phase 3, prior to submission of an NDA, method validation is required. Validation is a demonstration of optimization. By demonstrating the capacity of a method within the bounds of validation, optimal conditions for…
Engineering, Procurement, and Construction of Global Capital Ventures; Industrial and Commercial Project Development and Execution
More than 35 years of technical, managerial, and executive experience in engineering, procurement, and construction of global capital ventures have provided Expert with exceptional prerequisites to address any facet of industrial and commercial project development and execution. Since 2003, he…
PE, RPLS, CFM – Civil Engineer, Utilities and Drainage
Civil engineering, water and wastewater utilities, drainage and flood control. Forty years of experience in civil and environmental engineering and project management. Designed and managed construction for more than $900M of public works, private and federal projects, including heading design…
Digital Transformation: Risk and Engineering
Working with global and international clients and organizations to address emerging, evolving and rapidly changing enterprise risk, governance, risk and compliance, operational risk and resilience, business continuity, crisis management, organizational and digital transformation, as well as control system testing, review,…
Technical Engineering
Areas of Expertise: Chemical Engineering, Distillation, Refining, Ethylene, Natural Gas Expert is a Degreed Chemical Engineer with over 35 years of progressive experience in the design, construction, commissioning, and operations management of process units from the US Gulf Coast through…
Applied Technology: Thermoplastics, PAEK Polymers, Polymer Additives, Polyolefins, Fibers, Composites, Curatives
Highly Credentialed Engineering & Business Strategist with distinguished career record of vitalizing disruptive innovation technologies and propelling commercialization efforts to competitively position products and drive growth within multiple markets for specialty chemicals industry titans. Accomplished in translating needs into valuable…
Senior Safety
Over 40 years experience in various facets of safety and mechanical engineering, including over 30 years experience addressing commercial nuclear power and/or Department of Energy (DOE) facility programs. Expert has served as Senior Worker Safety and Nuclear Safety Advisor for…
Managing Consultant, Project Director – Oil and Gas-Downstream, Feasibility Analysis, Technology Licensing, FEED, EPC, PMC, Joint Venture, Contract and Commercial
Managing Consultant, Project Director - Oil and Gas-Downstream, Feasibility Analysis, Technology Licensing, FEED, EPC/EPCM, PMC, Joint Venture, Contract and Commercial. An experienced Project Director and Managing Consultant with 35+ years global expertise (Europe, Middle East, Asia) in Oil and Gas,…
Silicone Process Chemistry
Expert has a strong background in experimentation, mechanism reaction kinetics, chemical synthesis, experience with silicon/silicone materials, computational chemistry/engineering, and material characterization. Expert has been inventor and project leader for multiple projects that results in +$1MM/yr in cost savings. Previous roles…
Medical Device Quality Assurance and Regulatory Compliance
Expert is a 34-year food, cosmetic, drug, biologic, clinical, medical device, and combination product non-technical quality assurance and regulatory compliance veteran with over 21 years of FDA/ governmental experience as an analyst and level II certified international medical device investigator…