Zhenyu Li

Director of Process Development @ SystImmune

About

o An integrator of multi-function and multi-team for complex biologics and bioconjugation development. An adaptive project manager. A humble team leader keeps learning. o 13 years of industry technical and management experience in upstream, downstream and conjugation process and analytics development to enable and improve cGMP manufacturing. ● Management of in-house and CDMO Process Development and Analytical Development activities ● As part of CMC leadership, managed cross functional collaboration among Development groups, QA, QC, and MFG teams. ● Management of process knowledge life cycle in a QbD framework. ● Staff development to enhance team performance, ● Experience with multiple modalities: Vaccines including live virus and multi-valent peptide-protein complex, and membrane nanoparticles. Virus-like nanoparticles, VDC, mAbs, non-tagged recombinant proteins, enzymes, Fc and HSA fusion proteins, protein-drug conjugates. ● Working knowledge and on-floor experience of biologics cGMP manufacturing Profile: o Excellent knowledge and technical expertise in therapeutic proteins and targeted therapy o Strong experience in solving complex problems working with in-house MFG, CDMOs and CROs o Technical communicator among multifunctional matrixes. o Excellence as a team builder and leader. o High level of integrity and positive, professional, can-do attitude. Expertise: o Develop phase-appropriate biologics process, and transfer to GMP manufacturing. o Produce pre-clinical and clinical supplies with PD group or through collaboration with MFG. o CMC document preparation. o Communicate with CDMO to deliver products and data timely. Technical Coverage: o Upstream Processes: stainless, single use, microcarrier and flatware cell culture for various cell types: CHO, HK293, adherent cells, bacteria, and yeast, with stable or scalable transient transfection, fed-batch, intensified fed-batch, and perfusion processes. o Downstream Processes: chromatography methods, depth filtration, tangent flow filtration (UF/DF), sterilizing filtration, formulation, filling. o Bioconjugation process o Assay Development o Data analysis: DoE modeling with JMP and Minitab.

Country

United States

City

Carlisle

Industry

Biotechnology

Skill

Regulatory Compliance, Cross-functional Team Leadership, Chemistry, Manufacturing, and Controls (CMC), Drug Development, External Manufacturing, Kanban, Process Engineering, Research and Development (R&D), Analytical Methods Development, Leadership, Communication, Agile Methodologies, Project Management, Bioconjugation, Team Management, Free Venture Capital Crash Course, Nanoparticles, Biologics, Good Manufacturing Practice (GMP), Biopharmaceuticals

Experience

Director of Process Development

SystImmune

2024-11 - Present · 1 yr 11 mos

Process development of biologics including multi-specific antibodies and antibody-drug conjugation. • New pipeline generation: developability, characterization, stability, formulation, and clinical phase process establishment as well as tech transfer to GMP • Linker chemistry for advanced drug delivery and activation • Digital platform building for data integration to speed up drug development • Global collaboration with other CMC teams to support regulatory filing and clinical supply. • CMC technicial lead for collaboration of late-stage ADC with external partner.

Director of Process and Analytics Development

Tonix Pharmaceuticals

2023-3 - 2024-6 · 1 yr 4 mos

Director of Process Development

Tonix Pharmaceuticals

2022-5 - 2024-6 · 2 yrs 2 mos

Director of Process Development

Cue Biopharma

2020-9 - 2022-3 · 1 yr 7 mos

Director of CMC

Versatope Therapeutics, Inc.

2020-7 - 2020-9 · 3 mos

Head of MS&T

Aura Biosciences

2019-9 - 2020-7 · 11 mos

Cambridge, Massachusetts, United States

Head of MS&T Responsibilities • Technology transfer and Technical Support for GMP capsids batch production at CDMOs. • USP and DSP Process improvement in -house and at CDMO for late stage production • Technical Documents drafting and review

Senior Scientist

Aura Biosciences

2018-1 - 2019-9 · 1 yr 9 mos

Senior Scientist, PAT/CMC Projects • Overseeing the Process & Analytical development functions and assay development for VLP and conjugates. • Management of PD and AD team • Management of Technology transfer to CMO • Continuous development activities to support CMO activities into Phase 3.

Scientist II

Agenus

2013-3 - 2018-1 · 4 yrs 11 mos

Greater Boston Area

Group leader in: Process development for mAb production: from fermentation, purification to formulation. Pilot scale production of mAbs up to 100+ grams. Development of mAb potency assay and other process-related assay. Development of personalized vaccine

Fellow, Tech support in therapeutic proteins

Scott & White Healthcare

2011-8 - 2013-3 · 1 yr 8 mos

Temple

• Assay development following FDA guidelines to support QA/QC and GLP pre-clinical/clinical study. •DMPK assays to support clinical trials. •Elisa assays to support anti-drug antibody detection. •Biochemical assays to support QA/QC. •FACS assay for immunotoxin efficacy in clinical trial. • Purification Process Development and cGMP manufacturing for PEGylated human arginase I. • Purification Process Development and cGMP manufacturing for AC-301 . • Orphan drug (bi-specific antibody) development. • GLP toxicity studies.

Postdoctoral Research Associate

University of Florida

2010-5 - 2011-6 · 1 yr 2 mos

GAINESVILLE, FL

Molecular and Cellular Biologist: Perform molecular pharmaceutical study with cancer cell models. Analyze data and draft manuscript. Advise graduate students in experiments. Collaborate with other fellows. PROJECTS: • Identification of the substrate of GRK5 in vitro. • The novel mechanism that PGE2 activates small GTPase RalA and regulates cancer cell motility.

Postdoctoral Fellow

Moffitt Cancer Center

2005-1 - 2010-5 · 5 yrs 5 mos

TAMPA, FL

Molecular and Cellular Biologist: Perform signal transduction study in cancer cell models. Analyze data and draft manuscript. Advise graduate students in experiments. Supervise summer students. Protein Chemist and Drug Screen Specialist: Purify and characterize proteins for in vitro assays and structure study. Design, improve and perform screening assays. Collaborate with other groups and cores. PROJECTS: • Phosphorylation of histone deacetylase SirT1. • Regulation of histone methylase SUV39H1 by SirT1 binding protein DBC1 • Structural study of oncoprotein MDM2/X with their inhibitory peptide PDI • Screening of chemical libraries for MDM2/X inhibitors. • Oxidation of MDM2 and its ability to recruit methylases onto target gene.

Postdoctoral Research Associate

Barbara Davis Center for Diabetes

2002-11 - 2004-12 · 2 yrs 2 mos

DENVER, CO

Biochemist: Purify and characterize membrane proteins with biochemical and biophysical methods. Separate the proteins with 2D-electrophorisis for MS analysis. Study pancreatic regeneration proteins for therapy purpose. PROJECTS: • Identification of membrane markers for type I diabetes. • Study on pancreatic regeneration proteins. .