Ran Li
Associate Director - Process and Analytical Development @ PackGene Biotech, Inc.
About
CMC leader with 10+ years of experience advancing preclinical, IND-enabling, and clinical-stage programs across Antibody/ADC (6+ years) and Cell & Gene therapy (8+ years) platforms in both biotech and CDMO environments. Proven track record in developing, scaling up, and tech transferring upstream, downstream, and analytical processes to GMP. Experienced in end-to-end CMC program leadership, including cross-functional project management, timeline and risk mitigation, and coordination of internal teams and external CDMO/CRO partners to deliver compliant, phase-appropriate drug substance and drug product processes
United States
Houston
Biotechnology
Cell line engineering and development, Cell Culture, Cell, Cancer, Cell Biology, Molecular Cloning, Confocal Microscopy, Fluorescence Microscopy, Western Blotting, Protein Expression, Microscopy, Flow Cytometry, Biophysics, Cell Signaling, RT-PCR, Immunohistochemistry, Protein Purification, Antibodies, Mouse Models, qPCR
Experience
Associate Director - Process and Analytical Development
PackGene Biotech, Inc.
Houston, TX
• Lead AAV upstream and downstream process development, MSAT and GMP technology Transfer • Manage programs across platform technology development, CRO operations, and CDMO projects • Drive AAV analytical platform method development, optimization, and technology transfer
Senior Manager - Process Development
CTMC
Houston, TX
• Lead and manage clinical RV producer cell line development for TIL and TCR-T programs • RV/LVV process development and QbD-driven, DOE-based process characterization • Execute MSAT efforts for viral vector process scale-up and GMP technology transfer
Senior Manager - Analytical Development
Bellicum Pharmaceuticals, Inc.
Greater Houston
• Develop 10+ cell‑based and molecular assays for CAR-T identity, purity and potency characterization • Manage assay qualification timelines and perform assay technology transfer to external CDMO partners • Lead analytical characterization to support cell therapy process performance qualification (PPQ)
Senior Scientist - Bioassay / Hybridoma / Cell Line Development
Klus Pharma Inc.
New Jersey
• Establish biochemical and cell-based assays for preclinical evaluation of antibody and ADC functions, including ADCC, CDC, drug-antibody ratio (DAR), internalization and tumor cell killing • Develop and execute high-throughput flow cytometry-based hybridoma screening (>15,000 clones) • Perform CHO cell serum-free adaptation and CMC cell line development for antibody production
Postdoctoral Researcher
UT Southwestern Medical Center
Department of Immunology; Department of Molecular & Cellular Medicine
• Collaborate with Peregrine Pharmaceuticals to co-develop highly potent cancer-targeting ADCs • Establish antibody expression, ADC conjugation and purification methods with a defined DAR=4 • Pre-clinical ADC evaluation in cell-based assays and in vivo PK/PD studies in mouse tumor models
Graduate student
Duke University
Department of Pharmacology & Cancer Biology
Undergraduate student
Tsinghua University
Beijing, China
Education
Duke University
Pharmacology
Tsinghua University
Biological Sciences and Biotechnology
Ran Li's Contact Information
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