Hailey (Yonghui) Y.
VP, Head of CMC Quality @ Kali Therapeutics
About
In-depth knowledge of vaccine and Biologics process development (proteins, vaccines, viruses, plasmids, ADCs); technology transfer; Process scaling up IND and BLA/NDA filing support PAI support and preparation Early and late phase process development, process characterization Downstream purification development and analytical skills Leadership and project management. Project management; Certified project management professional (PMP) and MBA Design of Experiments (DOE), JMP cGMP training and experience
United States
New York City Metropolitan Area
Pharmaceuticals
Viral Vaccines, Manufacturing, Good Manufacturing Practice (GMP), Research and Development (R&D), Antibodies, AFM, HPLC, SDS-PAGE, UV-Vis, Fluorescence Microscopy, Characterization, Purification, Process Development, Western Blotting, Protein Chemistry, Chromatography, Protein Purification, Biochemistry, Spectroscopy, Surface
Experience
VP, Head of CMC Quality
Kali Therapeutics
Founder
HYY Consulting
VP of Drug Substance Process Development
GeneScience Pharmaceuticals Co., Ltd.
• Managed the Drug Substance team (Cell line development and Protein Sciences, Upstream Process Development, Downstream Process Development, ADC Development, Pilot Plant: Tox and Clinical material Manufacturing, Commercialization), for Biologics products: recombinant proteins, mAbs, BsAb, ADC, mRNA, etc. • Project lead (PL) for company level late phase projects; Downstream purification team lead. • Supported IND and BLA/NDA filing (NMPA, FDA, EMA) for new products, new indications and post approval changes: Process validation preparation and runs; Filing documents preparation; Pre-approval inspection; etc. • Technology transfer of new developed processes to Manufacturing • Manufacturing support；Deviation investigation support; PAI support
Executive Director Process Development
WuXi Biologics
• Managed and scaled cross-functional teams across two US sites, delivering over 20 integrated and stand-alone CMC projects for biologics, ADCs, and vaccines. • Led the technical transfer of early-phase products into GMP manufacturing, aligning with regulatory standards. • Developed and executed site strategies as part of the senior leadership team, resulting in increased throughput and enhanced client engagement.
Sr. Director Process Development
WuXi Biologics
King of Prussia, Pennsylvania, United States
• Directed vaccine process development, including tech transfer to GMP facilities and COVID-19 vaccine process development. • Led purification teams through preclinical and clinical phases, ensuring compliance with global regulatory standards. • Managed cross-functional teams and client relationships, delivering successful outcomes in high-stakes vaccine programs.
Principle Scientist, Group leader
Pfizer
Vaccine process development: -Downstream purification process development (Proteins and polysacchirides) -Process analytical characterization -Assay harmonization and project management
Senior Scientist
Pfizer
Viral (bacteria) Vaccine process development: -CTM manufacture of viral vaccine -cGMP Raw material mangement -Down stream purification process development
Research Scientist
Unilever
Skin care products formulation development Sun screen formulation Skin material physical property characterization
Education
University of Delaware
Chemical Engineering
Iona University
Tsinghua University
Industrial Chemistry, Enterprise Management
Hailey (Yonghui) Y.'s Contact Information
Phone
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