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Drug Development (Small Molecules, Peptides, Biologics, Parenteral Nanoparticles); Drug Delivery
Expert is an expert in analytical instrumentation and analytical methods development and validation, especially for drug regulatory filings with the FDA and EMEA according to all FDA and ICH guidelines. He established a state-of-art core instrument department at Altus Pharmaceuticals…
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…
Pharmaceutical Chemical Process R&D, Manufacturing, Disaster Recovery, Software Design
As the IT Manager for a major pharmaceutical company Expert has expertise in selection and validation of document management systems, inventory control, instrument calibration systems, as well as computer software utilized in the pharmaceutical industry as a whole. He has…
Chemometrics, Data Interpretation, Statistics and Mining in Analytical Chemistry
He has 25 years experience in data analysis primarily involving analytical chemical data analysis, often called chemometrics. Application areas include biology (e.g. metabolomics of humans and mice, microbiology), medical applications (e.g. TB analysis in breath, salival analysis in dentistry), pharmaceuticals…
Controlled Substances, Blood/Breath Alcohol, Urine Drug Screen Issues, Chain of Custody, Chemistry
Expert has been involved in forensic science since 1976. He has testified over 1000 as an expert in drug identification for the prosecution over 1000 times while with the Florida Dept. of Law Enforcement Crime Laboratory. In addition, he was…
Viscometry, Instrumentation Design and Applications, Polymer Characterization and Processes
Expert has extensive experience in characterization of materials and property measurements, especially those related to molecular weight, molecular architecture, and material composition. He has several patents in related areas (viscometers, HPLC detectors, Clinical analysis of Blood and vital fluids) and…
cGMP Coatings, Pharmaceutical, Dietary Supplements, Adhesives, Die Cutting, Security Holograms, Printing, Operations Lean Management Metrics and Strategy, and Materials
Expert has worked in custom manufacturing – polymerization, mixing, coating and converting of cGMP adhesive and laminates - as a process engineering manager. In this role he lead operations and engineering on the corporate Business Strategy Team (BST) asserting direction…
Pharmaceutical, Chiral Chromatography; Chiral Separation; Chromatography Methods Development
Expert has 30+ years of analytical experience in pharmaceutical industries. She worked as an analytical scientist in Glaxo SmithKline and Johnson and Johnson. Her specialty is to develop analytical methods to support drug discovery and drug development groups. Her expertise…
Biotechnology, Molecular Biology, DNA Forensics, Immunology, Virology, Vaccines, Antibodies, PCR, RNA, FDA submissions
Expert has over 40 years of experience in Biochemistry, Molecular Biology, Molecular Genetics and Biotechnology. His academic research career led to 80 publications and 5 Biotechnology patents which enjoy a high impact rating and feature innovative methods in DNA, RNA…
Applied Computational Chemistry, Polymer Science and Analytical Science
Expert has been a recognized expert and consultant in the chemical industry for more than 20 years. His computational chemistry experience has spanned everything from the "what if" questions of identifying target molecules to synthesize... to understanding why a particular…