Xuefeng S.
Head of Quality Control Cell Therapy .
- Role
- Senior Director at Abelzeta
- Location
- Rockville, MD, US
- LinkedIn followers
- 500 followers
About Xuefeng S.
An accomplished and driven QC leader with a proven track record of accelerating regulatory success in cell and gene therapy. I excel in analytical development, process development support, and comprehensive quality control strategies, contributing to multiple successful regulatory filings and clinical trials. Passionate about building and empowering high-performing teams to deliver exceptional results.
Experience
Senior Director
Aug 2023 — Present · Rockville, MD, US
Direct the AD/QC strategy for flagship CAR-T products (JNJ-90••••96, in global Phase 1B/II clinical trials (NCT05••••63, in collaboration with J&J.Spearheaded the end-to-end design, commissioning, and certification of a GMP QC laboratory, including team building, equipment qualification (IQ/OQ/PQ), and QMS establishment.Lead the definition of Quality Target Product Profile (QTPP), identification of Critical Quality Attributes (CQAs), specification setting, stability studies, and comparability protocols to support global regulatory filings.Serve as a core technical leader bridging AD/QC, PD, Manufacturing, and Regulatory Affairs to accelerate IND/BLA pathways for CAR-T and TIL pipelines.
Education
Institute of Biophysics, Chinese Academy of Sciences
Master of Science - MS
The University of Texas MD Anderson Cancer Center UTHealth Graduate School of Biomedical Sciences
Doctor of Philosophy - PhD
吉林大学
Bachelor of Science - BS
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