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Guy J. Gloor Ph. D
Summary:
Engineering manager with over 25 years experience in the development and scale-up of GMP active pharmaceutical ingredients and bulk fine chemicals.
Demonstrated a broad range of abilities including chemical synthesis, plant design, plant validation, line management, reaction engineering, process safety and regulatory document preparation. Particularly skillful in
driving collaboration between chemistry, engineering and plant functions.
Work Experience:
2010 –
Present President and Principal
Consultant
Chesilton
LLC.
Chesilton is a full service consulting firm assisting conpanies in the design, development, and scale-up of fine chemicals, GMP pharmaceutical intermediates and active pharmaceutical
ingredients. This includes route selection, equipment selection, experimental plan development, hazard analysis, CMC development, and outsourcing.
2007-2010 Director,
Early Development Engineering and Process
Safety.
Merck & Co. /Schering-Plough Research
Institute
Union, New Jersey
- Changed the business model of process safety at SPRI to one of collaborative engagement rather than independent
oversight.
- Led a group which combined process engineering, kinetic analysis, and modeling with the hazard analysis lab work to drive the development
effort.
- Led incident investigations for both internally produced and contracted materials.
- Project leader for
Garenoxacin, an in-licensed externally manufactured antibiotic
Authored the starting material argument and API synthesis section of the NDA.- Plant operations
representative for Job Rotation and Green Chemistry initiatives.
2006-2007 Director of Plant
Operations.
Schering-Plough Research Institute, Union, New Jersey
- Responsibility for all clinical and non-clinical API and intermediate production at SPRI’s U.S chemical
site (Union, NJ).
- Responsible for GMP and OSHA compliance of plant operations.
- Financial and line
responsibility for 4 plants; approx. 70 people.
- Increased production of API and intermediates 15% over previous
year.
- Decreased the turnaround time of batch documentation 80%.
- Oversaw final closure of consent decree action
items and closure of commercial operations.
Senior Principal Engineer
1992-1999, 2003-2006 Schering-Plough Research Institute, Union, New Jersey
- Managed API chemical synthesis plant U-18A (Clinical Bulk Supply Facility).
- Represented
plant operations in the development of scale-up strategies for processes brought to plant.
- Line
responsibility for 3 engineers and 18 hourly staff.
- Led the synthesis plant startup team and
validation effort.
- Key member of the plant design team with P&ID and equipment selection
responsibility.
1991-1992 Chemical Engineer
Florasynth Corporation, Teterboro, New Jersey
- Invented novel continuous azeotropic distillation crystallization
procedure for maltol (3-hydroxy-2-methyl-pyr(4)one) U.S. Pat. 521756
- Constructed continuous pilot unit to purify 1kg/day from 50 kg abies balsamea resin.
- Prepared PFDs with material and energy balances for 50kg/day plant.
1984-1991 Senior
Synthesis
Chemist
Croda Incorporated, Edison, New Jersey
- Expertise in industrial oxirane chemistry.
- Scaled-up over 30 commercial products.
- Invented
novel shampoo thickener (Crothix) U.S. Pat 5192462
- Developed new cost effective synthesis route to
alkyldimethylhydroxyethyl ammonium chloride quaternaries.
Education:
Doctor of Philosophy (ChemE) 2003
Imperial College of Science Technology and Medicine - University of London
Thesis: Modelling the interfacial properties of complex fluids with density functional theory and computer simulation.
Master of Science in Advanced Chemical Engineering 2001
Imperial College of Science Technology and Medicine -
University of London
Thesis: Monte Carlo simulation of dipolar liquid crystals using variable-shape techniques.
Bachelor of Science in Chemical Engineering 1990
New Jersey Institute of Technology - Newark, NJ
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