Bob Westney is currently President and Director of Quality and Operations for Cryologics Inc., which specializes in formulating in-house microbial isolates into the format required for compendial tests. He is also Principal Consultant for Westney & Associates Consulting LLC. Bob has 25 years of experience in the GMP industry, including Quality Control Microbiology, Quality Assurance and Regulatory Affairs. He has worked for biotechnology and pharmaceutical manufacturers, as well as pharmaceutical, cosmetic, and food contract testing laboratories. He holds a Master of Science degree from Temple University in Quality Assurance/Regulatory Affairs. He is Regulatory Affairs Certified (RAC), and is a Certified Manager of Quality/Organizational Excellence (CMQ/OE). He is a member of the Pharmaceutical Microbiology Forum (PMF), the American Society for Microbiology (ASM), the Parenteral Drug Association (PDA), the Regulatory Affairs Professional Society (RAPS), and a Senior Member of the American Society for Quality (ASQ). He is Editor of the Pharmaceutical Microbiology Forum Newsletter.
February 2010 - Present President of Cryologics - a microbiology-based company which specializes in formulating in-house microbial isolates into the format required for compendial tests.
December 2010 - Present Westney and Associates Consulting, LLC. Providing consulting services to pharmaceutical and biotechnology clientele in the areas of Quality Systems, Regulatory Compliance, Quality Control Microbiology, and Aseptic Manufacturing. Perform GMP auditing for compliance with 21 CFR 210/211, 21 CFR 111 and 21 CFR 820.
March 2006 - Oct. 2010 Associate Director, QA Microbiology Oversaw two functional groups providing microbial identification, material qualifications and inventory management. Responible for GMP compliance.
August 2005 - Jan 2006 Associate Director, Quality Systems/Regulatory Affairs. Responsible for GMP compliance, hosted customer audits, lead for aseptic processing.
June 2003 - August 2005 - Manager, Quality Control. Managed Quality Control activities relating to aseptic manufacture (fill/finish) of influenza vaccine, including environmental/clean utility monitoring, microbial identifications and excursion investigations. Compiled data and issued periodic environmental and clean utility trend reports. Established the trend report format that became the requirement for worldwide facilities.
August 1999 - May 2003 Diosynth TRP, Inc. Held various positions of increasing responsibility.