Zhenyu Gu
Executive Director CMC | Analytical Sciences | Process Development | Formulation Development | Tech Transfer | DS/DP manufacturing | CDMO/CRO management | Regulatory Submissions | Protein, CGT, ADC/AOC, mRNA
- Role
- Executive Director, Cmc, Analytical Sciences at Xencor
- Location
- South San Francisco, CA, US
- LinkedIn followers
- 500 followers
About Zhenyu Gu
About 20 years of biotech leadership accelerating therapeutics across diverse modalities, from preclinical through IND/BLA to commercialization. Expertise spans assay development, formulation, drug substance/drug product manufacturing, characterization, validation, tech transfer, molecule design/developability, device integration, and regulatory filings in complex, fast-paced environments.Extensive experience managing global CDMO/CRO partnerships, leading high-performing cross-functional teams, and resolving critical CMC challenges across analytical, formulation, and manufacturing domains.Focused on shaping CMC strategies that advance pipeline assets while enabling long-term scalability and regulatory success. Major contributions to multiple IND, IMPD and BLA/NDA submissions—supporting both early-stage and commercial products through strategic oversight, scientific leadership, and cross-functional collaboration.
Experience
Executive Director, Cmc, Analytical Sciences
Dec 2025 — Present
Education
Chinese Academy of Sciences
Doctor of Philosophy - PhD, Biochemcial Engineering
Uppsala University
Visiting PhD researcher, Biochemcial Engineering
Skills
- Protein Engineering
- Elisa
- Hplc
- Assay Development
- Western Blotting
- Purification
- Protein Chemistry
- Characterization
- Chromatography
- Sds-Page
- Protein Purification
- Cell Culture
- Mass Spectrometry
- Biochemistry
- Biophysics
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