Over fifteen years of pharmaceutical experience with increasing responsibility in analytical R&D, quality control and CMC coordinating GLP/GMP studies, transferring methods, characterizing raw materials, API, oral dosage, parenteral and nasal spray formulations for clinical release/commercial manufacturing, coordinating toxicity, chemistry and formulation studies, and developing small molecule, peptide and enantiomeric separations.

• Manages an analytical/quality control group while leading or serving on cross-functional teams
• Writes and organizes the analytical portion of an ANDA
• Directs POP and post-NDA analytical processes
• interfaces effectively with QA, RA and CROs