Zheng Meng

Senior Director, Analytical Development and CMC

Ph.D. scientist with cross function experience in Analytical Development (AD) and Quality Control (QC).
Broad drug development experience in rare disease therapy, immunology-oncology, and vaccine development, with a wide variety of large biomolecule modalities, including mRNA-LNP, monoclonal antibody, Fc fusion protein, and protein nanoparticle.
Demonstrated team building, managing and coaching skills to establish high performance teams.
Extensive hands-on and managing experience of analytical method development, qualification, validation, and method transfer under cGMP regulation.
Technical expertise in potency assay development and validation, including cell-based bioassay, ELISA, SPR-based immunoassay for drug product potency, impurity, and host cell protein (HCP) analysis.
In-depth knowledge with a broad spectrum of biochemical and biophysical analytical methods, including HPLC, CGE, icIEF, spectrometry, particle size analysis, etc.
In-depth understanding of cGMP and ICH regulatory requirement and guidelines for biological and ATMP products development.
Extensive regulatory submission experience in authoring IND/IMPD and BLA/MAA, addressing queries from health authorities including US, Canada, and EU countries.

Talks About
#analytical

Preferred Locations
#NorthAmerica