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)

None

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.

Analytic Chemistry Pharma Analysis Qc In Pharmaceutical Stability Analysis Expiration Date Biopharm And Chemical Labs Fda Cgmp Ich Iso Requitrements Quality Systems Cmc Technical Literature Search. Chromatography Spectroscopy Bioanalytical Drug Analysis Organic Chemistry Drug Litigation Pharmaceutical Litigation Support Pharmaceutical Lawsuits Counterfeit Pharmaceuticals Pharmaceutical Patent Litigation Support Pharmaceutical Corporate Litigation Support Pharmaceutical Manufacturing Process Analysis Analytical Chemistry Testing Analytical Chemistry Labs Analytical Result Evaluation Chemistry Expert Witness Pharmaceutical Manufacturing Support Pharmaceutical Product Analysis Active Pharmaceutical Ingredient (api) Analysis Fda Compliance Fda Regulatory Compliance Good Manufacturing Practices Gmps Gmps Fda Ich Iso Pharmaceutical Analysis Quality Control Quality Assurance Pharmaceutical Stability To Set Expiration Date Bioanalytical Drug Analysis Chromatographic Analysis Spectroscopic Analysis Adulterated Drugs Adulterated Drug Analysis Synthetic Organic Chemistry Organic Chemistry Physical Organic Chemistry Pharmaceutical Impurities Pharmaceutical Degradation Products Impurity Analysis Residual Solvent Analysis Trace Impurity Analysis Toxic Substance Analysis Technical Literature Searching Pharmaceutical Literature Searching Quality System Requirements Laboratory Training Chemical Laboratory Training Analytical Laboratory Training Laboratory Validation Validation Drug Development Regulatory Submission Nda Anda Bla Snda Regulatory Affairs Expert Witness

active pharmaceutical ingredient (api) analysis, adulterated drug analysis, adulterated drugs, analytic chemistry, analytical chemistry labs, analytical chemistry testing, analytical laboratory training, analytical result evaluation, anda, bioanalytical, bioanalytical drug analysis, biopharm and chemical labs, bla, cgmp, chemical laboratory training, chemistry expert witness, chromatographic analysis, cmc, counterfeit pharmaceuticals, drug analysis, drug development, drug litigation, fda, fda compliance, fda regulatory compliance, gmps, good manufacturing practices gmps, ich, impurity analysis, iso, iso requitrements, laboratory training, laboratory validation, nda, organic chemistry, pharma analysis, pharmaceutical analysis, pharmaceutical corporate litigation support, pharmaceutical degradation products, pharmaceutical impurities, pharmaceutical lawsuits, pharmaceutical literature searching, pharmaceutical litigation support, pharmaceutical manufacturing process analysis, pharmaceutical manufacturing support, pharmaceutical patent litigation support, pharmaceutical product analysis, pharmaceutical stability to set expiration date, physical organic chemistry, QC in pharmaceutical, quality assurance, quality control, quality system requirements, quality systems, Regulatory Affairs expert witness, regulatory submission, residual solvent analysis, snda, spectroscopic analysis, spectroscopy, stability analysis expiration date, synthetic organic chemistry, technical literature search. chromatography, technical literature searching, toxic substance analysis, trace impurity analysis, validation