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Len Mestrandrea, PhD




Dr. Mestrandrea has a Ph.D. from St. John's University and Pacific Western Univsresity and an M.S. from Wagner College.  A past Chief Microbiologist for FDA, Dr. Mestrandrea has established a broad-based Pharmaceutical Consultancy with experience in industry, government and academia.  Possesses strong managerial and scientific experience in the areas of Quality Assurance, Quality Control, product quality performance, sterile manufacturing and regulatory compliance.  In addition  to nine years of experience as the Chief Microbiologist within the US Food and Drug Administration in addition to more than twenty years of experience in the pharmaceutical industry.
Experienced in the preparation for and conducting of PAIs and GMP and foreign FDA inspections.  Well versed in issues of GMP and FDA compliance, microbiological analysis and methods development.

 

Employment History

September 2008 - Present  Mestrandrea Consulting LLC; an independent consultancy providing scientific compliance and technical expertise on new product development programs.   Focus on technical expertise for the interpretation, development and revision of standards and regulatory guidance documents.  Review PCRs, CMC sections for new product applications, validation documents for new processes as they pertain to microbiology and manufacturing processes.  Training in the areas of manufacturing support, environmental monitoring and bioburden contamination control.

May 2002 - June 2007 Sr. Science Advisor, Pfizer Global QA.  Provided consultative input on new product development, manufacturing support and regulatory guidance in the areas of microbiology and contamination control. 

1991 - April 2002  Schering-Plough Corp.  Held positions of increasing responsibility and influence in QA and QC microbiology areas. 

1989 - 1991 QA Manager, Microbiology for DuPont Merck.

1986 - 1989 Sandoz Pharmaceuticals.  Held various positions of increasing reponsibilties in the manufacturing organization, responsible for qualification of new manufacutring facility.

1970 - 1978  Supervisory/Chief Microbiologist Food and Drug Administration (FDA)

  • USP Microbiology and Sterility Assurance Expert Committee
  • Pharmaceutical Research Manufacturer's Association (PhRMA) - Quality Control Section & Biological Section
  • PhRMA, Quality Control Microbiology Technical Working Group, Chairperson
  • Parenteral Drug Association (PDA) - President Metro Chapter (1992-1994), Presently Chapter Liaison
  • American Society for Microbiology
  • National Registry of Microbiology
  • Pharmaceutical Quality Research Institute (PQRI), Member
  • Member of Program Training Committee for NJPQCA
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