Zhonghua Zhu
Associate Director, Process Development @TScan Therapeutics
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WORK HISTORY
Associate Director, Process Development @TScan Therapeutics
Waltham, MA, US
Leadership & Organizational Development • Built and led a high-performing team of 5 reports, including Ph.D-level scientists and functional managers. Provided mentorship and strategic career planning within and beyond direct team; contributed to broader talent development initiatives. Process Development – Autologous TCR-T Cell Therapy • Directed end-to-end process optimization for multiple TCR-T programs targeting hematologic and solid tumors. Designed and optimized core unit operations. Led DoE-based process characterization and comparability studies to support IND filings and clinical manufacturing readiness • Supported GMP manufacturing, supported MSAT for internal and external tech transfer, supported AD’s assay developmentVector Development – Non-Viral Gene Delivery • Developed and optimized a non-viral transposon/transposase vector system for clinical-stage TCR-T cell therapy, including mRNA transposase and DNA payload constructs. Drove vector design decisions to balance expression, stability, manufacturability, and regulatory requirements. Led CDMO selection, technology transfer, and GMP manufacturing for both mRNA and plasmid vectors Regulatory & Compliance • Authored and reviewed CMC sections for multiple IND and IND amendments. Participated in FDA meetings as CMC representative, addressing regulatory questions and presenting development strategies Strategic Projects, Business Development & IP • Technical lead in cross-functional evaluation of next-generation therapy opportunities, including lentivirus based in vivo CAR-T, iPSC-derived and allogeneic T-cell platforms. Conducted competitive and scientific landscape assessments on gene delivery vectors (viral, non-viral, LNP, VLP), gene editing tools, in vivo/ex vivo T-cell engineering technologies, and CDMO manufacturability • Performed scientific diligence; authored scopes of work (SOWs), MTAs, and technical briefs to support strategic collaborations • Contributed to multiple IP filings
EDUCATION
New York University
Doctor of Philosophy - PhD, Neurobiology
Nanjing Normal University
Bachelor of Science - BS, Biotechnology
Nanjing Normal University
Master of Science - MS, Developmental biology
ABOUT ZHONGHUA ZHU
PhD in Neurobiology from NYU. Biotech professional with 8 years industry experienceSenior scientist from Biogen: Experience in early drug discovery of neurological diseases: SME in disease modeling, molecular biology, stem cell (iPSC), CRISPR genome editing. Manage a team with 4 reports. Experience in CRO managementAssociate Director from TScan Therapeutics: Experience in Process Development of TCR-T autologous cell therapy for oncology, SME in viral / non-viral vectors and delivery, cell engineering and production at scales. Manage a team with 5 reports. Experience in CRO / CDMO management, regulatory IND filing and business development
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