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Fda Regulatory Specialist, Expert Witness and Forensic Consultant.

PH.D. physical organic chem., 25 years pharma, chem., phys. and bio. analysis, 13 years management of labs., 6 years lab consult. ICH, cGMPs, FDA and DEA regs.- all lab. functions (tech., GMP and RA)

EXPERT ID: 13987

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Location:  US

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ADDITIONAL INFORMATION

 

Short Biography:

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.


 

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