Senior consultant with 25+ years expertise in laboratory and scientific informatics supporting multinational life science companies achieve critical business objectives in their research, development and manufacturing operations. Deep working knowledge of combining processes, technology and people to design and implement solutions for the pharmaceutical, medical device, biotech and food industries. Areas of Expertise: • Strategic planning and project management for IT in QC and R&D laboratories • Process modeling and reengineering• Data modeling and information architecture• User requirements analysis and vendor selection • Experience with LIMS, Laboratory Execution Systems, Electronic Notebooks; interface design between LIMS and MES, ERP and ELNs. Proven leadership of cross-functional and matrixed implementation teams through design, development, validation, production implementation and operation processes. Recognized for ability to unite and successfully coordinate the activities of project stakeholders with differing agendas, cultures and knowledge and ultimately ensuring successful delivery of completed systems and attainment of client business goals.
Listed skills include Computer System Validation, 21 Cfr Part 11, Lims, Business Analysis, and 19 others.