Martin has a MS in Synthetic Organic Industrial Chemistry from the University of Central Florida and a Ph.D. in Biochemical Engineering from Duke University.
Since 1985, Martin has gained extensive, multidisciplinary experience in the pharmaceutical industry where he has held technical and senior management level positions in development, manufacturing, and quality assurance. His professional tenure includes Burroughs-Wellcome Co., Eli Lilly & Co., and Bristol-Myers Squibb Consumer Products.
Martin's experience base ranges from development of a concept to marketable implementation for solids, liquids, and semisolids. Martin has diverse areas of interest and is knowledgeable in medical science, mathematics, chemistry, biology, engineering, material science, and microbiology. Martin has a passion for bringing order to chaos and applying optimization methods to processes utilized for production and manufacturing including industrial synthetic organic chemistry, extraction/separation technology, isolation technology, formulation, purified water systems, HVAC systems, packaging, and manufacturing workflows.
Initially trained in process development, scale-up, and optimization, Martin has utilized experimental designs and its scientific principles to improve economies of scale, enhance the design and performance of engineering optimizations, and streamline validation efforts for bulk pharmaceutical active ingredient manufacturing and solid dosage manufacturing including granulation, mixtures, compression and coating. Martin is experienced in microbial strain selection, production scale fermentation operations, separation science, and industrial synthetic chemistry for bulk pharmaceuticals. Martin has extensive experience in facility start-up, commissioning, project management, process improvement strategy, process optimization, cost savings, and validation projects for processes and equipment (including autoclaves, ovens, glassware washers, filling equipment, bulk manufacturing, aseptic operations, tablet operations, clean rooms, refrigerators, building management systems, utilities (chillers, compressors, HVAC systems, purified water systems) and facilities).
Martin has lead and managed validation efforts for start-up companies as well as companies under consent decree and FDA warning letters.
Ivey has a BS in Chemistry from Shorter College and is a certified Clinical Data Manager
Since 1987, Ivey has gained extensive, multidisciplinary experience in the clinical trials and pharmaceutical industry where she has held technical and senior management level positions in development and quality assurance. lvey's professional tenure includes Pittman-Moore, Valley Environmental Testing Corp., CompuChem (Roche Laboratories), ClinTrials, and Duke Clinical Research Institute (Duke University).
lvey's experience base ranges from environmental chemistry to clinical data and clinical trial management. Ivey has diverse areas of interest and is knowledgeable in quality assurance, statistical process control, mathematics, chemistry, clinical trials. and clinical database design and testing. Ivey has a talent for detail and applying optimization methods to processes utilized for production and manufacturing including industrial analytical chemistry, extraction/separation technology, and process workflows.
Initially trained in analytical development. Ivey is trained in cGLPs and has experience in QC Laboratory management, separation science, and industrial analytical chemistry as applied to the environmental, pharmaceutical, and clinical sciences. Ivey has extensive experience in project management, process improvement, process optimization, cost savings, and validation projects for processes and equipment (including test method validations. technology transfer, autoclaves, ovens, glassware washers, aseptic operations, and laboratory operations).
Ivey has led and managed laboratory, clinical trial, validation, and remediation efforts for start-up companies as well as companies under consent decree and FDA warning letters.