CMC Consulting for the Pharmaceutical Industry
 
McArdle & Associates
Jim McArdle
President
Tel: (760) 652-5216
Email: Jim McArdle
  • Strategy
  • Regulatory
  • Development
  • Documentation
  • Manufacturing
  • Chemistry
  • Control
James V. McArdle - Curriculum Vitae  
  Summary of Work Experience  
  2006 – 2008 Archemix Corporation, Cambridge, Massachusetts  
    Vice President – Chemistry, Manufacturing, and Control  
       
  1999-2005 Isis Pharmaceuticals, Carlsbad, California  
  2005-2006 Vice President, Quality Assurance and Compliance  
  1999-2005 Vice President, Analytical Development and Quality Control  
       
  1983 – 1999 SmithKline Beecham, Upper Merion, Pennsylvania  
  1992-1999 Group Director, Analytical Sciences  
  1990-1992 Director, Analytical Chemistry (Tonbridge, England)  
  1988-1990 Assistant Director, Analytical Chemistry (Tonbridge, England)  
  1983-1988 Senior Investigator, Analytical, Physical, and Structural Chemistry  
       
  Selected Affiliations  
  Member ICH Expert Working Group on Quality, representing Pharmaceutical Research and Manufacturers of America (PhRMA), 1994 – 2005  
       
  Topic Leader Quality Technical Group, Pharmaceutical Research and Manufacturers of America, 2005  
       
  Topic Leader Development of ICH guideline Q3C, Residual Solvents  
       
  Deputy Topic Leader Development of ICH guideline Q8, Pharmaceutical Development  
       
  Deputy Coordinator all ICH Quality Topics for PhRMA 1998-2003
 
       
  Member Quality Technical Group, Pharmaceutical Research and Manufacturers of America, 2005  
       
  Chairman Manufacturing and Marketing section, Asia Pacific Economic Cooperation (APEC) initiative, Life Sciences Innovation Forum (LSIF), 2003-2004  
       
  Member Analytical R&D Steering Committee, Pharmaceutical Research and Manufacturers of America, 1993-2001  
       
  Chairman Analytical R&D Steering Committee, Pharmaceutical Research and Manufacturers of America, June, 1997 through December, 1999  
       
  Member Technical Steering Committee, Pharmaceutical Research and Manufacturers of America. Liaison to Regulatory Affairs Coordination Committee, 1998-2000.  
     
  Education  
  National Institutes of Health Postdoctoral Fellow - Department of Chemistry, University of California, Berkeley, CA.  
  Research Director- Kenneth N. Raymond  
  Research Topic: Microbial Iron Transport Compounds  
     
  Ph.D. - Department of Chemistry, California Institute of Technology, Pasadena, CA.  
  Research Director: Harry B. Gray  
  Research Topic: Electron Transfer Kinetics of Redox Proteins  
     
  Sc.B. (Honors) - Department of Chemistry, Brown University, Providence, RI.  
  Research Director: Richard Eisenberg  
  Research Topic: Active Species Bound to Metal Complexes  
  Complete curriculum vitae available here  
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