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Biocompatibility Testing and Biomaterials for Medical Devices
Consulting experience in the set up and protocols for biological tests, pre-clinical evaluation submission summaries (regulatory), product (medical device) cleaning validation, GLP laboratory set up and management, biocompatibility/ toxicilty testing Strategy for the pre-clinical evaluation / toxicity testing of an…
Pharmaceuticals
PROFESSIONAL EXPERIENCE: Development, implementation and monitoring of clinical pharmacy services consistent with current practice guidelines for the following units: Neonatal Intensive Care, Pediatric Oncology, Pediatric Surgery, Pediatric Emergency Medicine, General Pediatrics, and Pediatric Intensive Care units. Formulary management and drug…
Infectious Disease Diagnostics and Scientific Leadership
I am a computer scientist who built and led bioinformatics teams at Lawrence Livermore National Laboratory (LLNL) from 1978-2018. This included the Human Genome Program (1987-2000) and a pathogen bioinformatics team (2000-2018). My team designed PCR assays, microarrays, and sequencing…
Pharmacokinetics/Pharmacodynamics
Expert has over 37 years of experience in the pharmaceutical industry, including work as an independent consultant. As a consultant he offered preclinical and clinical pharmacokinetic, pharmacodynamic, and pharmacometric support services, with emphasis on providing strategic planning services throughout a…
Forensic DNA Analyst
Expert founded his company in 1993, a forensic scientist who specializes in the analysis of DNA and the use of insects in legal investigations. Expert has evaluated and provided expert guidance for more than four hundred criminal and paternity cases,…
Food Safety, Food Microbiology, Foodborne pathogens, Bacteriophage therapy, Microbiology, Genomics, Whole Genome Sequencing, Diagnostic tests, Antibiotic Resistance
Expert has been formally trained in basic and food microbiology and has developed extensive expertise in this area. As a Expert, he has conducted numerous (applied microbiology) research projects that evaluated bacterial physiology under various conditions with respect to growth…
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,…
Synthetic Organic Chemistry for Diagnostics, Pharma, and Biotechnology
Expert developed and successfully managed a 14-step synthetic method for a patentable alternative to a fluorescent probes. Expert has developed 4 synthetic methods for small molecule linker conjugates (with a total of 15 steps) for antibody production and synthesis that…
Sterile Compounding, USP 797/795/800, Home Infusion, TJC/ACHC/BOP Regulations, Healthcare/Change/Project Management, Acute/Hospital Pharmacy Management, Pharmacy Automation, Mail Order Pharmacy, DME
Expert is an experienced PharmD, Director of Pharmacy and Assistant Clinical Professor with 6 years of experience at small, medium, large, level 1 trauma academic, acute care and long-term acute care hospitals. She has deep experience in pharmacy operations, finance,…
Medicine and Healthcare
Expert is a physician informaticist who uses evidence-based medicine to develop clinical protocols. His experience ranges from developing process/procedures and relationships to mentoring and coaching. He has amassed more than a decade of understanding the pharmaceutical and medical industry and…