Ms Saltzstein has over 20 years experience in the biotechnology industry focusing on quality and CMC regulatory aspects of novel biologics, including viral-vectored gene transfer therapeutics and viral vaccines ranging from pre-IND through to late-stage clinical development.
Immediately prior to joining Viralytics Rae served as an independent consultant providing CMC, regulatory and quality systems expertise to clients ranging from start-up gene therapy companies to large non-profit vaccine research organizations.
From 2013 until 2015 Rae served as Sr. Director of Quality at Celladon Corporation where she was responsible for overseeing aspects of outsourced testing and manufacturing of a viral-vectored gene therapy candidate for CHF.
Prior to Celladon Rae was at Targeted Genetics Corporation for over 11 years, last serving as Sr. Director of Quality and Regulatory Affairs where she oversaw all regulatory filings, quality assurance and quality control supporting GMP manufacturing and testing as well as GLP and GCP compliance for programs ranging from HIV vaccines to gene therapy candidates for cystic fibrosis, inflammatory arthritis, CHF and oncology indications.
Rae received her B.S. in Microbiology from Oregon State University (USA) and holds the RAC (US) credential from the Regulatory Affairs Professionals Society.