Michelle Tseng PhD Azzur Group

Michelle Tseng is an experienced CMC technical leader with over ten years of immunology research experience at the Pittsburgh, Vanderbilt, and NYU Langone medical centers and 15 years of clinical and commercial analytical development for small and large-molecule medicines and biologics and QC/CAP-accredited laboratory operational excellence. Early in her career, Michelle worked on analytical methodologies to answer pharmacokinetics and pharmacodynamic questions on HIV, antibody-based medicines, vaccines, and antibody-drug conjugates when working at Merck and Roche. She deepened her technical expertise in analytical methods for lot-release, characterization of viral/non-viral vectors, process intermediates, and drug products of mRNA, oligonucleotides, and gene and cell therapies. Her expertise employs statistical analysis and data modeling to provide valuable product and process understanding insights. For the last 15 years, she has contributed to seven FDA-approved GCT INDs and successful drug approvals from IND through BLA, including Rituximab, Keytruda, Yescarta, and Tecartus for various clinical indications. Michelle is one of the senior leaders at the Azzur Labs, responsible for global biologics GMP/GLP testing implementation, an affiliate Sr. CMC consultant, and a manuscript reviewer for major journals. Michelle has two patents and has earned a Bachelor of Science, Master of Science, and Doctor of Philosophy in Science.