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Manufacturing Technologies for Pharmaceuticals, Biologicals, Biotech and Vaccines
Expert is an independent consultant to bio-pharmaceutical, medical device and vaccine manufacturers, associated equipment suppliers and investors, with over 40 years experience in aseptic process technology, new product and business development, marketing strategy and regulatory compliance for manufacturing of pharmaceuticals…
Sterility Assurance Expert in terminal sterilization (Ethylene Oxide, Moist Heat, Radiation, Dry Heat) and Aseptic Processing to Medical Device and Pharmaceutical companies.
. Expert is President and Principal Consultant for his consulting company - a consulting LLC. Prior to going into consulting, he was Director of Corporate Quality Technology/ Sterilization Science, for Alcon a Novartis company where he was responsible for sterilization…
Clinical Laboratory Science, Lab Directing, Lab Diagnostics, Medical Technology, Hospitals, Testing
Expert is a clinical laboratory scientist with 30 years of experience in the industry covering laboratories in the hospital, national reference, and large physician office settings. He is the founder of a consulting company which began in 2009. The company's…
Plant Pathology
Expert was trained as a mycologist, but her career steered her into the discipline of plant pathology. Throughout the 50+ agriculture research projects that Expert has conducted, she has accrued vast experience on the cultivation of a number of crops…
Biotechnology, Pharmaceuticals, Diagnostics, Market Research, and Writing
Expert possesses two decades' experience in consulting, market research, and medical writing experience in biotechnology. She possesses laboratory research experience in biotechnology as well. Expert has amassed two decades of consulting, market research, and medical writing experience in biopharmaceuticals and…
Microbiological Contamination Control
A principal with his eponymous consulting firm, Expert has amassed 30 years of experience in academia, industry, and consulting. The majority of his research and consulting work has been in the area of microbiological contamination detection and mitigation for pharmaceutical/biotechnology,…
IVD Assays and Diagnostic Tests Development
Expert's areas of expertise include the following: IVD (in vitro diagnostics) clinical laboratory regulation molecular diagnostics blood assay diagnostic instrumentation assay development CLIA-88 (Clinical Laboratory Improvement Amendments of 1988) clinical laboratory regulation quantitative risk analysis (risk assessment) laboratory management GLP…
Biochemistry, Drug Development, Antibiotics, Proteins, Medicines, Pathogens, and Pharmaceuticals
Expert serves on the faculty of a University, Department of Chemistry and Chemical Biology. He previously held a senior scientist and lecturer position at ETH Zurich, Switzerland. His interests are at the interface of chemistry and biology, where he is…
Biological Safety, Biosecurity, Dual Use Research of Concern, Microbiology
Ms. Expert has extensive experience conducting research with pathogenic E. coli and influenza viruses under the appropriate biosafety levels including BSL-3+ and BSL-3Ag. She has experience with reverse genetics, VLP formation, retrovirus manipulation, reporter assays, RNA isolation, and RT-PCR. She…
Molecular Biology, Genetics, Cancer Biology, Radiation Biology, Genetic Engineering
Expert was continuously funded 1990-2018 by the NIH (NCI, NIGMS), typically as PI of 2-3 concurrent R01 grants, and is currently funded by the American Lung Association (2020-2022). Expert published more than 130 reports of original research and reviews that…