Joe Rininger

Dr. Rininger brings more than 25 years of experience in biomedical research and biopharmaceutical product development, manufacturing, regulatory strategy, and program management, with particular expertise in vaccines, biologics, and gene therapy. As DoriNano’s CMC & Regulatory Lead on a fractional basis, he provides strategic leadership across CMC development, manufacturing, analytical and formulation development, regulatory planning, and IND-enabling activities as DoriNano advances its programs toward clinical translation.

Throughout his career, Dr. Rininger has supported and led multiple pre-IND and IND submissions and has advised both commercial and U.S. government-funded biopharmaceutical development programs. He previously served as program manager for a BARDA-funded program supporting the advanced development and commercialization of Flublok®, the first approved recombinant hemagglutinin-based seasonal influenza vaccine. His responsibilities spanned process and formulation development, analytical and quality systems, preclinical development, manufacturing technology transfer and validation, regulatory affairs, clinical development, and government program management.

Dr. Rininger has also led development and cGMP manufacturing transfer activities for multiple vaccine and biologic candidates. His experience includes licensing manufacturing technology and supporting regulatory submissions for Glybera, the first AAV gene therapy approved in the Western world, as well as securing NIH/NHLBI funding for AAV manufacturing process development. He has additional experience in biologics business development, technology licensing, CDMO activities, and NIH funding.

Dr. Rininger holds a Ph.D. in Toxicology from Cornell University and a B.S. in Marine Biology with a concentration in Biotechnology from Fairleigh Dickinson University. He is an inventor on multiple awarded and pending patents and has published in peer-reviewed journals and industry publications.