Ph.D.
I am a senior technical manager with extensive analytical development, stability assessment, pre- and post-approval documentation, technical service and quality control laboratory experience in the pharmaceutical and biopharmaceutical arenas. Providing analytical support for product development and optimizing critical technical & compliance aspects of laboratory performance are my areas of expertise. Whether challenged to establish a new laboratory, resolve complex technical issues, or build high quality staff, I consistently deliver strong and sustainable results. Significant accomplishments include:
. Creating Analytical Development, Method Validation, Stability Testing, Technical Services, and Product Development labs for new division of DuPont Merck
. Transforming key programs at Barr Laboratories from low-level technical competency and cGMP compliance into fully compliant and technically sound operations
. Providing critical gap analyses/audits of Development, QC, Stability and Contract Labs activities; prepared and implemented remediation plans to improve overall cGMP compliance and technical efficacy
. Educational credentials include an M.S. and Ph.D. in Physical Organic Chemistry from New York University and a B.S. in Chemistry from the University of Maryland
Employment: . Principal Consultant, Arlington Heights, IL 1998 - Present, Pharmaceutical Lab Consulting . Director, Analytical Development and Tech. Services, SoloPak Pharmaceuticals, Elk Grove Village, IL 1996-1998 . Associate Director, Analytical Development, DuPont Merck Pharmaceuticals, Inc, 1990-1996 . Director, Analytical Research & Development, Barr Laboratories, Inc., Pomona, 1987-1990 . Senior Research Chemist, American Cyanamid Co., Stamford, CT 1980 -1987
Due to space limitations, more extensive resume can be provided.
|
|