Findexperts.com: Litigation Support Experts. Findexperts.com: Litigation Support Experts.
  Home Store Join Expert Login Terms/Policy Faq Logout
          Find an Expert by "keyword" Location: Submit "keyword": To search by category:
       Expert Witness
Expert Witness

Litigation Support 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

Print this page

Location:  US

CLICK HERE TO CONTACT
THIS EXPERT OR TO RECEIVE
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.


 

Blinded CV

Category Directories:

 

Category Searches:


 
Chemistry Expert Witnesses Directory   Chemistry Experts Witnesses ;
Pharmacology Expert Witnesses Directory   Pharmacology Experts Witnesses ;
Pharmaceutical Manufacturing Expert Witnesses Directory   Pharmaceutical Manufacturing Experts Witnesses ;
Pharmaceutical Litigation Expert Witnesses Directory   Pharmaceutical Litigation Experts Witnesses ;

Some of the Keywords entered by this Expert:

Iso Requitrements Impurity Analysis Regulatory Submission Snda Fda
Drug Analysis Snda Good Manufacturing Practices Gmps Impurity Analysis Pharmaceutical Degradation Products
Validation Fda Regulatory Compliance Chemistry Expert Witness Laboratory Validation Laboratory Training
Anda Drug Litigation Drug Analysis Pharmaceutical Manufacturing Support Validation
Iso Iso Regulatory Affairs Expert Witness Cmc Quality System Requirements
Gmps Analytical Chemistry Labs Pharmaceutical Product Analysis Fda Compliance Pharmaceutical Degradation Products
Regulatory Submission Quality Control Fda Regulatory Compliance Laboratory Training Pharmaceutical Analysis
Pharmaceutical Analysis Biopharm And Chemical Labs Ich Analytic Chemistry Technical Literature Searching
Drug Litigation Drug Development Drug Litigation Spectroscopic Analysis Toxic Substance Analysis
Cgmp Pharmaceutical Stability To Set Expiration Date Qc In Pharmaceutical Pharmaceutical Patent Litigation Support Snda


Expert Witness
Copyright © 1996 - 2006 eWitness.com, LLC. All Rights Reserved. SiteMap Click here to view our Legal Disclaimer or Privacy Policy