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Pharmaceutical Manufacture and Supply in Startup New Product Companies & Acquisition Integration
Expert has successfully developed and led a diversity of complex operations and projects in a variety of cultures and environments. These range from turnarounds and startups of flagship greenfield operations to cross functional teams in world-wide new product launches, and…
Managing the Interface Between Owners and Engineering Contractors
Expert has successfully directed engineering and construction projects with values up to $700 million, primarily in the U.S. Working directly for the Owner, he most recently completed a $200 million project, 5% under budget and 2 months ahead of schedule,…
Chemical and Pharmaceutical Development – Comprehensive CMC
Expert has worked on research, development and manufacturing problems involving stereochemistry throughout his academic training and industrial career. Relevant examples include: development of scalable chiral and asymmetric syntheses; improvement of reaction stereoselectivity; tracking of chiral integrity in chemical processes; chiral…
Decontamination, Precision Cleaning, Ferrofluids, Nanoparticles, Process Design and Development
The behavior of colloidal particles (now nano particles) has been the focus of Expert's professional career, starting with his doctoral studies on the spontaneous agglomeration of fine powders in graduate school. While at AVCO Corporation, he did pioneering work in…
Strategy and Sales Analysis for In Vitro Diagnostics and Biopharmaceuticals
Expert has multiple experiences in evaluating and proposing strategy for brands or individual products. This list includes several existing diagnostic products where lifecycle planning needs require judicious selection of new and novel add-ons to an existing line. It also includes…
Pharma/Biotech Development, Life-Cycle Management, 505(b)(2), Chemical Development, CRO Services
Expert is a Pharmaceutical development leader with ~25 years drug development and manufacturing experience with large Pharma, large Biotech, and a highly successful small start-up. Managed large groups (from three different countries), teams and budgets. Played critical roles in several…
Protein Purification: Hands-on, Over 50 Projects Completed, Over 75 Proteins Purified
Expert has been actively involved in hands-on protein purification since 1985. Early work involved purification of enzymes and metal-binding proteins. From 1993 to 1997, as a Senior Scientist at a major biotech company, expert had very successfully developed methods for…
Process Automation
He has spent 14 years designing and maintaining power plant Digital Control Systems. He has led the checkout and startup of two new fossil power plants. He has spent 14 years teaching machines to think and see using PLCs primarily…
Process Inorganic Chemistry and Liquid Solid Crystallization and Fluid Bed Processes
He was deeply involved in a large segment of inorganic chemistry within SOLVAY who is a major actor (3 billions Euros turn over in inorganic chemicals). Expertise area covers most of steps of processes with special emphasis on crystallization: liquid…
Cleanrooms, Contamination Control, Ultrapure Media, Qualification and Validation, GMP, AMC
Expert has been active in aersol physics for more than 25 years. His PhD covers also the areas of environmental, indoor and cleanroom aerosols. He worked in a variety of scientific and technical projects covering the health effects of particles…