Mike Oneill
Director, Analytical Chemistry @Olon Usa
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WORK HISTORY
Director, Analytical Chemistry @Olon Usa
Concord, OH, US
EDUCATION
John Carroll University
Physical Chemistry
University of Pittsburgh
Chemistry
SKILLS
ABOUT MIKE ONEILL
Focused scientific leader with background in analytical chemistry within the pharmaceutical/biotech industry. Proven track record of success managing personnel, consultants, and clients. Over 25 years of experience in laboratory operations. Currently directing an Analytical Chemistry Department within the Chemical Development Division of a GLP/GMP CRO/CMO. Experienced in client management, business development, program/project management, financial budgeting and forecasting, regulatory/quality systems, continuous process improvement, and personnel management & development. Specialties: CMC, IND, CTD format, preformulation, drug development, purity assignment, reference standards and marker characterizations, retesting programs, crystallization, solid form selection, polymorph, salt form, co-crystal, IP/patent, particle size, manufacturing support, analytical development and validation, specifications, stability, impurities, genotoxics, preclinical/clinical/commercial testing, method transfers, equipment qualification, QA, QC, GLP, GMP, SOPs, ICH, FDA, DEA, audits, OOS and laboratory investigations, change control, data analysis.
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