Michael Kovner is a results-oriented professional with extensive experience in the pharmaceutical, biopharmaceutical and chemical industries with the world’s leading companies. He is proactive, reliable and versatile, with strong communication skills.Michael has experience in the areas of implementation, validation and administration of the laboratory data acquisition software, chromatography data software (CDS) and laboratory information management system (LIMS). Michael developed solutions for the appropriate R&D and QA/QC infrastructure to support FDA regulations (21 CFR Part 11). Michael created Empower software instrument performance verification projects, validation documents, SOPs, custom design reports and customized calculations for different analysis and products types.He is also experienced in the analytical method development as a research scientist. Michael provided analytical support and stability indicating test method development for a number of active pharmaceutical ingredients (API) and finished drug products. Michael completed start-up of a number of the cytotoxic laboratories, which included stability program for cytotoxic drug substances and injectable products. He developed, validated and performed testing methods under cGMP, including drug release testing methods for semi-solid formulations.Michael supported multiple global facilities and software systems. His performance has consistently been judged “superior” by his employers and colleagues.Specializing in the following areas of consulting:CDS Empower implementation including creation and validation of custom fields and reportsAdministration of EmpowerImplementation of StarLIMS v 10 with electronic laboratory notebook (ELN)Implementation of scientific data management system (SDMS)Administration of StarLIMS including SDMSCrystal Reports DevelopmentComputerized systems validationCDS and LIMS users training
Listed skills include Pharmaceutical Industry, Validation, 21 Cfr Part 11, Analytical Chemistry, and 15 others.
