Lexie Zhou
Cambridge
Summary
Accomplished Senior Scientist at Vor Bio with expertise in GMP process design and optimization. Spearheaded Phase I/II manufacturing enhancements, achieving over 10% cost savings and doubling yield. Proficient in CMC regulatory strategy and risk assessments, while fostering collaboration and leading cross-functional teams to drive impactful results in gene-edited therapies.
Overview
15
15
years of professional experience
Work History
Senior Scientist, Process and Product Lead
Vor Bio
Cambridge
01.2024 - Current
- Led a team of six to optimize Phase I/II manufacturing for a gene-edited HSC therapy, enabling Phase III readiness with >10% cost savings, ~30% faster production, >2x yield, and a fully closed harvest/fill-finish system.
- Successfully transferred process improvements to an external CDMO and managed ongoing technical execution.
- Authored key CMC documents (development reports, batch records, CPPs, FMEAs) and contributed to CQA, QTPP, and PQRA.
- Influenced Phase III CMC strategy across starting material control, cryopreservation, DP stability, and critical reagent (gRNA/Cas9) optimization.
- Served as PD lead supporting Phase I manufacturing at the CDMO; identified root cause of manufacturing failure, replicated it in PD lab, and implemented a corrective solution.
- Led a team of six in extensive optimization of the Phase I/II eHSC (trem-cel) clinical manufacturing process to enable Phase III readiness—achieving over 10% reduction in manufacturing/material cost, ~30% reduction in manufacturing time, more than doubling process yield, and a fully closed harvest and fill/finish system.
- Led matrixed teams internally and externally in de-risking clinical manufacturing failure, implemented key risk mitigations targeted at root causes with demonstrated improvements in process robustness and success.
- Influenced Phase III CMC strategy on topics such as starting material control, back-up graft cryopreservation strategy, DP stability and critical raw material optimization (gRNA/Cas9).
- Authored and supported key CMC documents including development reports, cGMP manufacturing batch records, process descriptions, CPP, FMEA, contributed to CQA, QTPP, PQRA.
- Served as person-in-plant and tech transfer lead for the pivotal phase trem-cel manufacturing process to CDMO. Played a key role in fostering collaborations with many external partners.
Scientist II, Process and Analytical development
Vor Bio
Cambridge
09.2022 - 12.2023
- Led the development of prototype large-scale manufacturing processes of HSC and CAR-T products through internal tech transfer of small-scale PoC Research processes; Influenced pipeline strategies through comprehensive gap/feasibility analyses of the Minimal Viable Processes and Products.
- Drove critical potency and impurity assay development, characterization and stability testing of VCAR33 to enable IND filing.
- Supported regulatory filing of trem-cel (IND amendment/updates, Briefing Book).
- Led investigation into the quality and stability of mobilized peripheral PBMC starting material, assessing the impact of apheresis collection, transport & storage, and process handling on manufacturing performance.
- Directed the eHSC back-up graft cryopreservation process, stability and characterization assays.
Postdoctoral Fellow/ Senior research associate
University of North Carolina at Chapel Hill
Chapel Hill
03.2016 - 08.2022
- Stem cell aging biologist with 6+ years of experience in studying hematopoietic aging, immunological aging and immunosenescence under physiological and pathological conditions.
- Developed a novel ultra-low input next-generation sequencing (NGS) method enabling ChIP-seq, RNA-seq and ATAC-seq on the study of the transcriptome and epigenome of rare hematopoietic stem and progenitor cells sorted from young and old mice.
- Uncovered the epigenetic basis of hematopoietic and immunological aging through bioinformatic analysis of the largest epigenomic and transcriptomic dataset to date—over 300 high-quality profiles spanning 13 hematopoietic cell types across the developmental hierarchy.
- Co-authored multiple publications identifying key regulators of hematopoiesis and immune aging under homeostatic and stress conditions.
Graduate Student Researcher
Chinese Academy of Sciences
Shanghai
09.2010 - 02.2016
- Established, characterized and maintained hESC and iPSC lines; identified master regulators in controlling ESC self-renewal and pluripotency.
- Enhanced neural differentiation protocols for human and mouse ESCs/iPSCs and elucidated the role of transcription factor SOX2 in both maintaining self-renewal and initiating neural lineage commitment.
- Mapped transcriptional and epigenetic dynamics during hESC neural differentiation using advanced NGS techniques, revealing the interplay between epigenetic landscapes and master transcription factors in directing cell fate decisions.
Education
Postdoctoral Fellow -
University of North Carolina at Chapel Hill
Chapel Hill08.2022
Graduate Research Student -
Chinese Academy of Sciences
Shanghai, China02.2016
Bachelor of Science -
Zhejiang University
Hangzhou, China07.2010
Skills
- GMP/GLP process design and optimization
- Scale-up & tech transfer
- Assay development and qualification
- GMP manufacturing
- CMC regulatory strategy and submission writing
- Understanding of ICH guidelines
- Risk assessments
- Stability testing
- Comparability studies
- Apheresis process
- Electroporation
- Magnetic Cell Selection
- Cell Separation
- Flow Cytometry
- Controlled Rate Freezer
- In vitro cell biology
- In vivo cell biology
- Establishment of human and murine ESC
- Characterization of human and murine ESC
- Manipulation of human and murine ESC
- Neural differentiation from ESC/iPSC
- Isolation of hematopoietic stem cells
- Culture of hematopoietic stem cells
- Editing of hematopoietic stem cells
- Generation of CAR-T
- Culture of MSCs
- Culture of myeloid cells
- FACS sorting
- Potency assays
- Mouse model
- Bone marrow transplantation
- Tissue harvest and analysis
- CRISPR/Cas9
- Molecular cloning
- Transfection
- Viral transduction
- ELISA assays
- Luminex assays
- NGS
- Bioinformatic analysis
- Immunofluorescence
- Western Blotting
- PCR/qPCR/ddPCR
Publications
- Epigenetic Profiling of Hematopoietic Aging Reveals Impaired Control of Chromatin Dynamics During Lineage Specification, Zhou, C., Magg J., Koche R., Yu H., Guang H., Levine R., He S., Sharpless N., Manuscript in submission. Selected for oral presentation at the Cold Spring Harbor Meeting, “Mechanism of Aging”, 2020, PI: Norman Sharpless
- Comprehensive profiling reveals mechanisms of SOX2-mediated cell fate specification in human ESCs and NPCs., Zhou, C., X. Yang, Y. Sun, H. Yu, Y. Zhang and Y. Jin., Cell Res, 26, 2, 171-189, 2016
- RPL11 deficiency induces p53-dependent anemia in mice via p21 induction and cell cycle arrest in Pre-CFU-E and CFU-E erythroid precursors., Franklin, D., Zhou, C., Jin, A., Liu, S., Liu, J., Yin, F., Lu, R., Arend, K.C., Zengli Guo, Z., Chou, W., Ting, J., Moorman, N.J., Wang, G., Wan, Y., He, S., Zhang, Y., Under revision at Blood
- DCAF1 regulates Treg senescence via the ROS axis during immunological aging., Guo Z, Wang G, Wu B, Chou WC, Cheng L, Zhou C, Lou J, Wu D, Su L, Zheng J, Ting JP, Wan YY., J Clin Invest, Nov 2, 130, 11, 5893-5908, 2020
- Nucleolin maintains embryonic stem cell self-renewal by suppression of p53 protein-dependent pathway., Yang A, Shi G, Zhou C, Lu R, Li H, Sun L, Jin Y., J Biol Chem, 286, 50, 43370-43382, 2011
- PHB Associates with the HIRA Complex to Control an Epigenetic-Metabolic Circuit in Human ESCs., Zhu Z, Li C, Zeng Y, Ding J, Qu Z, Gu J, Ge L, Tang F, Huang X, Zhou C, Wang P, Zheng D, Jin Y., Cell Stem Cell, 20, 2, 274-289 e277, 2017
- Stk40 represses adipogenesis through translational control of CCAAT/enhancer-binding proteins., Yu H, He K, Wang L, Hu J, Gu J, Zhou C, Lu R, Jin Y., J Cell Sci, Aug 1, 128, 15, 2881-90, 2015, 10.1242/jcs.170282
Awards
- Director’s Special Award at Graduate Research Appreciation, 2015
- Academic Excellence Scholarship, 2008
- Academic Excellence Scholarship, 2009
- Outstanding Student Leader, 2007
- Outstanding Student Leader, 2008
- Outstanding Student Leader, 2009
Timeline
Senior Scientist, Process and Product Lead
Vor Bio
01.2024 - Current
Scientist II, Process and Analytical development
Vor Bio
09.2022 - 12.2023
Postdoctoral Fellow/ Senior research associate
University of North Carolina at Chapel Hill
03.2016 - 08.2022
Graduate Student Researcher
Chinese Academy of Sciences
09.2010 - 02.2016
Postdoctoral Fellow -
University of North Carolina at Chapel Hill
Graduate Research Student -
Chinese Academy of Sciences
Bachelor of Science -
Zhejiang University
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