Ray Cardin, MS
TCG Consultant
Bringing over 35 years of biotechnology industry experience and a degree in Microbiology, Mr. Cardin can provide a practical, experience-based insight. Starting his career at the Quality Control Microbiology Laboratory bench, Mr. Cardin eventually managed QC teams that executed bioburden, LAL, sterility testing, and EM programs for several Boston area-based corporations.
After achieving an M.S. in Innovation and Technology at Boston University, he was assigned to manage the manufacturing of aseptically filled and freeze-dried proteins. Leading Genzyme aseptic manufacturing, Mr. Cardin’s team supported the organization through the submission and approval of 5 commercialized Drug Products gaining invaluable experience in both US and international regulatory requirements.
Since 2012, Mr. Cardin has been leveraging his experience and knowledge consulting with numerous Biotechnology companies from process development through regulatory submissions and post-marketing optimization. His combination of in-depth experience with current aseptic manufacturing equipment and methods and well-versed familiarity with contemporary published international regulatory requirements, coupled with his strong background in Microbiology, enables him to readily contribute to teams looking to effectively develop and/or efficiently transfer their aseptic manufacturing processes in support of regulatory filings and milestone goals.