Mitch Rosner

Mitch Rosner has a diverse work experience in the field of quality assurance and regulatory affairs. Mitch has served as the Vice President of Quality at AnaptysBio, where they were responsible for ensuring compliance with various regulations and overseeing quality management systems. Prior to that, they worked as the Consulting Director of Quality and Regulatory Affairs at LuTran, providing compliance advice for early-stage pharmaceutical companies. Mitch also has teaching experience as an Instructor for Good Manufacturing Practices at the University of California San Diego, where they emphasized compliance with current good manufacturing practices. In addition, they have held leadership positions at Aridis Pharmaceuticals, Quality Consulting Associates, Synthetic Genomics, and Algenol Biotechnology, where they oversaw quality assurance and analytical development. Mitch also has experience in academia as a courtesy faculty member at Florida Gulf Coast University and as the Acting Chief Operating Officer at Infrasign, LLC. Mitch began their career as the Head of Analytical Sciences at Novartis Pharmaceutical Corporation. Overall, Mitch Rosner has a strong background in quality assurance, compliance, and analytical development in the pharmaceutical and biotechnology industries.

Mitch Rosner holds a Doctor of Philosophy (PhD) degree in Pharmacology and Toxicology, which they obtained from the University of Arizona between 1986 and 1989. Prior to that, they received a Master of Science (M.S.) degree in Toxicology from the same university, studying from 1982 to 1985. Mitch completed their undergraduate education at The George Washington University from 1978 to 1982, earning a Bachelor of Science (BS) degree in Chemistry.

In addition to their formal education, Mitch Rosner has obtained various certifications throughout their career. Mitch became a Preventative Controls Qualified Individual (PCQI) through the Food Safety Preventive Controls Alliance (FSPCA) in August 2017. In October 2016, they obtained the Certified Biomedical Auditor (CBA) certification from ASQ. In the same year, they also earned the Clinical Research Auditing Certification from Barnett International. Mitch achieved the Certified Quality Auditor (CQA) certification from ASQ in December 2014 and became a HACCP Manager through the National Environmental Health Association in September 2014. Prior to their career in auditing and project management, Mitch Rosner obtained the Chemist certification from the American Chemical Society in May 1982. Mitch has also completed various certificate programs, including the Master Project Manager certification from the AAPM ® American Academy of Project Management ® in January 2012, and the Certificate Program in Project and Program Management from UC Santa Cruz in December 2011.