A dedicated analytical research, product development, and quality laboratory leader with 25+ years of industry experience, 15+ years of management experience, and graduate degrees focused on scientific leadership. Possess a broad pharmaceutical science skill base with competencies in analytical, production, quality, regulatory, and resource management with an ability to see the “big picture” Demonstrated leadership, management, and organizational skills with an attention to detail in the execution of timeline driven projects under budget constraints Able to obtain results by integrating the respective strengths of people, processes, and technology Possess strong written and verbal communication skillsPossess an extensive background in analytical testing (chromatography: HPLC, GC, SEC, etc., dissolution and drug release: USP Apparatus 1,2,3,4, spectroscopy: FTIR, UV-Vis, etc., wet chemistry, etc.), method development, validation and transfer, stability testing management, regulatory submissions, metrology (including computer system’s validation), and OSHA regulationsProven record of promoting GMP compliance and instituting quality systems in previously deficient laboratory environments, as well as the relocation and set-up of compliant analytical laboratories
Listed skills include Validation, Laboratory, Metrology, Chromatography, and 45 others.