EMPLOYMENT HISTORY

June 2008-present: Independent Consultant for Drug Development in Pharma and Biotech Industry.

Helped in developing and evaluating methods for characterization of large and small molecules. Worked with clients to prepare documents and answer FDA’s questions. Advised client on building analytical laboratory for quality control of combination products. Provided advices to the pharmaceutical and biotech industry on drug development. Involved in a feasibility study for biosimilars and application of QbD (quality by design) for several projects. Consulted instrumental companies on instrument enhancement to better fit the needs of pharmaceutical/biotech industry.

2001-2007: Director of Analytical Chemistry at Cytokinetics, South San Francisco, CA.

Established Analytical R&D department. Supported target discovery and target validation (protein identification). Developed analytical methods for compound profiling (plasma protein binding, P450 inhibition, ADME and DMPK studies). Worked on determination of physical properties (solubility, log P measurements). Developed purity and stability indicating methods for API and formulated product. Successfully developed a service IV formulation. 

2001 (April-October): Sabbatical at Genomics Institute of the Novartis Research Foundation, San Diego, CA

Developed a high throughput purification LC-MS system.

1996-2001: Head of the Analytical Laboratory in Core Technology, Novartis Pharma, Basel, Switzerland

Assisted drug discovery process by providing research chemists with analytical support (HPLC, HPLC-MS, CE, MEKC, and CEC) and physicochemical characterization of drug substances (salt selection programs, polymorphism programs, solubility, log P measurements, plasma protein binding, P450 inhibition). Evaluated different separation techniques and applied them in drug discovery.

1995-1996: Head of the Analytical Laboratory in the “Kilolab”, Preclinical Research, Sandoz Pharma, Basel Switzerland

Developed and enforced HPLC-methods for in-process control of the pharmaceutical products under GMP guidelines

1988-1995: Head of Laboratory in the Analytical Research and Development, Sandoz Pharma, Basel Switzerland

Performed different stability programs for the active ingredients and final drug products under GMP guidelines. Lead the group responsible for determination of drug properties in solution, drug-excipients interactions, and salt selection programs. Worked on the development of computer assisted HPLC method development with instrumental companies in Switzerland and Germany.

1986-1988: Postdoctoral research with M.L. Lee, Brigham Young University, Provo, Utah

Worked on different applications of capillary and packed column Supercritical Fluid Chromatography.

1983-1986: Research Assistant, Department of Chemistry, San Diego State University, San Diego, CA, Applied inverse gas chromatography and differential scanning calorimetry (DSC) in studying solute-solvent interactions.

1982: Research Assistant, Department of Chemistry, Ohio State University, Columbus, OH

Developed and evaluated capillary GC columns for the separation of aromatic hydrocarbons.

1979-1981: Research Assistant in petrochemical industry, Petrohemija, Pancevo, Yugoslavia

Lead a gas-chromatography group.