Michael Tran
Senior Director, Omeros Corporation

Professional degree with extensive experience in pharmaceutical and analytical method development and validation, drug substance characterization, stability testing, and laboratory investigation.

• Expertise in solving complex technical challenges for analyses, processes and products.
• Extensive experience of HPLC, GC/MS, ICP-OES, ICP-MS, GF/AAS, NMR, XRF, Dissolution, Automation, and Spectroscopy.
• Familiar with compendial requirements, application of good manufacturing practices (GMP) regulations, and the interpretation of International Committee on Harmonization (ICH) guidelines.
• Coordinated and managed analytical support for development projects, including API characterization, raw materials, in-process and impurities testing.
• Experienced with solid, liquid and, topical dosage-form products and analytical requirements, including complex drug products such as multiple API’s.
• Integral member of technical project teams requiring extensive interaction with all levels of scientific and engineering personnel as well as customers, both domestic and international.
• Have collaborated with Regulatory experts on IND/NDA submissions.
• Managed cross-functional product teams in a GMP environment.