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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…
Environmental Analysis and Forensic Ecology
Environmental forensics The field of environmental forensics is an emerging discipline, and covers a wide range of environmental sciences. Expert specialises in forensic ecology - the examination of environmental accidents, especially (but not exclusively) affecting aquatic habitats. His work has…
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…
Wastewater, Trade Effluent, Organic Waste Treatment, Analytical Science, Water Quality and Pollution
Expert is an experienced analytical chemist specialising in the analysis of waters, wastewaters, sludges and formal samples from both a regulator industry and regulated industry point of view. Experience of the design and implementation of effluent monitoring programes for various…
Analytical Optical Spectroscopy, Chemometrics, Petroleum, Polymorphs and Diagnostics
Expert has taught courses and performed investigations in many areas of analytical chemistry including analytical spectroscopy, qualitative analysis, quantitative analysis, computer programming methods, algorithm developments and instrument developments. The primary goal of his research is to develop practical analytical instrumentation…
Implementation and maintenance of Quality Management Systems, Pharmaceutical GMP for Excipients
Expert has applied his scientific background in various companies over the past 25 years. He has set up and managed spectrophotometric and electron microscopy laboratories - choosing and installing (including EDX and WDX analysers), undertaking research and developing a range…
Polymer Science
Expert has worked in the coatings industry for 3 years prior to working at a large petrochemical company for 6 years. After that he spent another year and 3 months working for a large polyolefin company in Austria. During this…
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…