CTO / Member of USP’s AAV Gene Therapy Expert Panel
An entrepreneur and CGT expert, who drives innovation in cell & gene therapy at uBriGene.
CEO
Influential biotech-entrepreneur, pioneering global innovation with visionary stewardship.
President, NA Operations
20+ years in operational management, investments, and strategic partnerships.
Director of Quality Assurance
23+ years in quality systems with extensive GMP expertise.
Director of MSAT/GMP
25 years in process development, tech transfer, and cGMP operations.
Director of Process Development
Experienced leader in CGT products process development.
Director of QC
Experienced PD/CMC leader in cell & gene therapy development.
Director of QA
25+ years in GMP, expert in strategic regulatory approvals
Associate Director of Regulatory Affairs
11 years in biologics regulation; successfully filed 20+ INDs/BLAs globally.
Executive Director of Business Development
Decades of expertise in advanced therapy development, with a strong operational track record.
Senior Director of Business Development
A builder of impactful biotech strategic partnerships.
Director of Marketing, North America
A seasoned marketing professional with decades of experience in life sciences and CGT CDMOs.
CTO & Head of QC / Member of USP’s AAV Gene Therapy Expert Panel
As the Chief Technology Officer at uBriGene Biosciences, Dr. Sun brings a wealth of expertise in the cell and gene therapy fields. With a Ph.D. from The University of British Columbia, she stands as a seasoned scientist with notable accomplishments in medicine and biotechnology, particularly in the fields of hematology and cell and gene therapy. Her prolific career is marked by the publication of over 30 academic papers in esteemed journals like PNAS, and the acquisition of 17 invention patents.
Beyond her scientific achievements, Dr. Sun demonstrates remarkable entrepreneurial acumen. She played a pivotal role in the founding of Vigene Biosciences and uBriGene, where she drove forward innovative advancements in cell and gene therapy technologies. Under her leadership, uBriGene achieved significant milestones, securing numerous international patents in areas such as viral vectors, CRISPR gene editing, and pioneering the new CGT delivery modality, mRNA/circRNA RNP.
She also led the development of CAR-T technology, especially ICAR30 T cells for Hodgkin lymphoma, and filed an international patent application under the PCT to obtain independent protection of intellectual property. She also led the development of CAR-T technology, especially ICAR30 T cells for Hodgkin lymphoma, and filed an international patent application under the PCT to obtain independent protection of intellectual property. She also led the development of CAR-T technology, especially ICAR30 T cells for Hodgkin lymphoma, and filed an international patent application under the PCT to obtain independent protection of intellectual property. She also led the development of CAR-T technology, especially ICAR30 T cells for Hodgkin lymphoma, and filed an international patent application under the PCT to obtain independent protection of intellectual property.
CEO
Mr. Li Qichen, Master of Laws from Shandong University, Senior Engineer of Pharmaceutical Engineering, served as the general manager of an investment company. In 2012, he initiated the establishment of Vigene Biosciences Inc. and served as Group Director and General Manager of China Company. In June 2021, he presided over and participated in the acquisition of Vigene Biosciences by Charles River Laboratories, a world-renowned company, for nearly $300 million.
In 2015, as a co-founder, he founded Yiming Biotech, focusing on the preparation of GMP-level vectors for cell and gene therapy drugs. At present, the company has established a GMP production base service network serving global ATMP innovative enterprises in China and the United States, and has helped customers complete a total of 18 registration applications for IND projects in China and the United States and have been approved to enter clinical trials.
She also led the development of CAR-T technology, especially ICAR30 T cells for Hodgkin lymphoma, and filed an international patent application under the PCT to obtain independent protection of intellectual property. She also led the development of CAR-T technology, especially ICAR30 T cells for Hodgkin lymphoma, and filed an international patent application under the PCT to obtain independent protection of intellectual property. She also led the development of CAR-T technology, especially ICAR30 T cells for Hodgkin lymphoma, and filed an international patent application under the PCT to obtain independent protection of intellectual property. She also led the development of CAR-T technology, especially ICAR30 T cells for Hodgkin lymphoma, and filed an international patent application under the PCT to obtain independent protection of intellectual property.
President, NA Operations
Alex Chen is the President for Overseas Operations and Business Development at uBriGene Biosciences Inc. He is responsible for expanding overseas business and market share. Alex has over 20 years of experience in operational management, investment, acquisitions and strategic partnerships.
As part of his responsibilities for managing the North American operations, he oversees corporate projects, commercial developments, and facility operations. Prior to this role, he served as Managing Director of Eastern Capital Inc., where he was responsible for USD $1 billion asset under management portfolio for an array of clients from the mining, commercial and financial services industries.
He was also an acting advisor on an investment project for issuing USD $500 million bond for a pharmaceutical company which was listed on the Hong Kong Stock Exchange. Alex also held several leadership positions at Rio Tinto Alcan, RCI Capital Inc., Ministry of Transportation and Infrastructure BC, Worley Parsons and Westmar Advisors. He holds a BSc in Civil Engineering from Hunan University and a Master of Engineering degree from the University of British Columbia (UBC).
Director of Quality Assurance
James Boykin has over 23 years of experience in quality systems with extensive GMP knowledge. He joined uBrigene (US) in March 2024 and oversees the QA team supporting GMP manufacturing. Previously, James was at Forecyte Bio, Vigene Biosciences and AstraZeneca where he held QA positions of management / director responsibilities.
James holds a bachelor’s degree in chemistry from University of Southern Maine and was certified as both an ASQ Quality Manager and Quality Auditor. He also proudly served in the US Navy for 4 years. With over 23 years of experience in quality systems and extensive knowledge of GMP, James joined uBrigene (MD) to oversee the QA team responsible for GMP manufacturing. He is also seasoned at commissioning efforts to enable clinical Phase 1/2 manufacturing, where he was an integral part of build out and qualification of several GMP sites, including the current uBrigene GMP site in Maryland.
He was also an acting advisor on an investment project for issuing USD $500 million bond for a pharmaceutical company which was listed on the Hong Kong Stock Exchange. Alex also held several leadership positions at Rio Tinto Alcan, RCI Capital Inc., Ministry of Transportation and Infrastructure BC, Worley Parsons and Westmar Advisors. He holds a BSc in Civil Engineering from Hunan University and a Master of Engineering degree from the University of British Columbia (UBC).
Director of GMP Manufacturing
With 25 years of extensive experience in process development, scale-up, tech transfer, and cGMP operations, Jenny Zhao is a senior leader in the establishment and management of GMP laboratories and production platforms, with a specialized focus on the Adeno-Associated Virus (AAV), adenovirus, lentivirus, induced Pluripotent Stem Cells (iPSC), and Chimeric Antigen Receptor T-cell (CAR-T) therapies.
In her current role as Director of MS&T/GMP Operations at uBrigene in Maryland, USA. Prior to her position at uBrigene, Jenny served as Executive Director of PD/GMP at Forecytebio, Senior Director of MS&T at Vigene Biosciences, A Charles River Company (CDMO), and Upstream Scientist at Teva, PA, USA. Jenny holds a Master’s Degree in Chemical Engineering from the University of Waterloo, Canada.
He was also an acting advisor on an investment project for issuing USD $500 million bond for a pharmaceutical company which was listed on the Hong Kong Stock Exchange. Alex also held several leadership positions at Rio Tinto Alcan, RCI Capital Inc., Ministry of Transportation and Infrastructure BC, Worley Parsons and Westmar Advisors. He holds a BSc in Civil Engineering from Hunan University and a Master of Engineering degree from the University of British Columbia (UBC).
Director of Process Development
Guoan Wang is currently Director of Process Development. He joined Ubrigene from Innoforce Biopharmaceuticals, where, for three years, he built and led process research and development teams for gene therapy products including plasmid DNA, mRNA, viral vectors (AAV and LV) and non-viral vectors (LNP).
Before that, he was Director of Plasmid Production at Vigene Biosciences, where he spent three years leading the plasmid DNA business before its acquisition by Charles River Laboratory. He has a Ph.D degree in Biochemistry from Shanghai Institute of Organic Chemistry of Chinese Academy of Sciences and had six years of postdoctoral training at NIH, Yale and MIT. His long industrial experience also include research and development of Molecular Biological products, partly supported by multiple NIH SBIR awards.
He was also an acting advisor on an investment project for issuing USD $500 million bond for a pharmaceutical company which was listed on the Hong Kong Stock Exchange. Alex also held several leadership positions at Rio Tinto Alcan, RCI Capital Inc., Ministry of Transportation and Infrastructure BC, Worley Parsons and Westmar Advisors. He holds a BSc in Civil Engineering from Hunan University and a Master of Engineering degree from the University of British Columbia (UBC).
Director of QC
Gavin has over 15 years of experience in biotechnology, with a focus on cancer immunotherapy, cell therapy process development, and CMC. Before joining uBriGene, he built AffyImmune’s CMC team, leading a CAR-T product through Phase 1 manufacturing and QC release, and driving the tech transfer to a CDMO for Phase 2 readiness.
Gavin also led process and assay development for Simcere Pharmaceutical’s first allogeneic CAR-NK product and spearheaded the development of novel cell therapy pipelines from platform building to clinical manufacturing, including his work at MustangBio, where he helped transfer Mustang’s first CAR-T and gene therapy product for clinical trials. He earned his Ph.D. from Peking University and completed his postdoctoral fellowship at UC San Francisco.
He was formerly the SVP of Operations and Business Development at Biostem Life Sciences before assuming the roles of chairman of the scientific advisory board and a member of the Board of Directors. He is a former co-founder & Chief Technology Officer at Lacerta Therapeutics, an AAV gene therapy company developing manufacturing, capsid engineering and clinical programs for CNS disorders. He holds a B.S. in Biology & Chemistry from St. Lawrence University and a Ph.D. in Pharmacology & Experimental Therapeutics from the University of Florida.
Director of QA
Mark Sye has over 25 years of experience in supporting and enhancing GMP operations, demonstrating a decisive leadership style and a strategic approach to decision-making. He is well-versed in business practices within the biopharmaceutical industry and is recognized as a motivational leader and effective problem-solver. Mark possesses advanced skills in supervision, team building, and customer service.
His problem-solving abilities, utilizing a risk-based approach and Six Sigma tools, have successfully led to regulatory inspection approvals. Before joining Ubrigene, Mark held leadership positions at Catalent, MacroGenics, GSK, Baxter Bioscience, and Becton Dickinson Microbiology Systems. He holds a B.S. in Medical Technology from Morgan State University, along with certifications as a Black Belt in Six Sigma and in Master Lean Manufacturing.
He was formerly the SVP of Operations and Business Development at Biostem Life Sciences before assuming the roles of chairman of the scientific advisory board and a member of the Board of Directors. He is a former co-founder & Chief Technology Officer at Lacerta Therapeutics, an AAV gene therapy company developing manufacturing, capsid engineering and clinical programs for CNS disorders. He holds a B.S. in Biology & Chemistry from St. Lawrence University and a Ph.D. in Pharmacology & Experimental Therapeutics from the University of Florida.
Associate Director of Regulatory Affairs
Totally eleven years experience in regulatory affairs of biologics. Successfully submitted over 20 INDs and BLAs in various countries and regions, including FDA, NMPA, EMA, Health Canada and TGA and five expedited programs in FDA and EMA
Scott completed a postdoctoral fellowship at St Jude Children’s Research Hospital. He earned his PhD from the Indiana University School of Medicine, his Masters from Northwestern University, and his Bachelors from Purdue University.
He was formerly the SVP of Operations and Business Development at Biostem Life Sciences before assuming the roles of chairman of the scientific advisory board and a member of the Board of Directors. He is a former co-founder & Chief Technology Officer at Lacerta Therapeutics, an AAV gene therapy company developing manufacturing, capsid engineering and clinical programs for CNS disorders. He holds a B.S. in Biology & Chemistry from St. Lawrence University and a Ph.D. in Pharmacology & Experimental Therapeutics from the University of Florida.
Executive Director of Business Development
Kenneth Warrington, Ph.D., serves as the Executive Director of Strategic Business Develop and Head of Technical Services for uBriGene Bioscience. He has decades of broad expertise across the cell and gene therapy product development continuum from discovery through GMP-compliant manufacturing to support IND-enabling pre-clinical and early-stage clinical programs. He has deep knowledge in advanced therapy manufacturing, including live attenuated and virus-like particle vaccines, live challenge viruses, viral vectors, and cell & gene-modified cell therapies.
He served on the faculty at the University of Florida, Pediatrics-Division of Cellular & Molecular Therapy, with a research program focused on AAV vector development and production. Following his transition into industry in 2008, Dr. Warrington has held the lead technical operation and business development roles for global contract testing and manufacturing organizations, including Meridian Life Science, SGS Life Science, Wuxi Apptec and Genscript ProBio.
He was formerly the SVP of Operations and Business Development at Biostem Life Sciences before assuming the roles of chairman of the scientific advisory board and a member of the Board of Directors. He is a former co-founder & Chief Technology Officer at Lacerta Therapeutics, an AAV gene therapy company developing manufacturing, capsid engineering and clinical programs for CNS disorders. He holds a B.S. in Biology & Chemistry from St. Lawrence University and a Ph.D. in Pharmacology & Experimental Therapeutics from the University of Florida.
Senior Director of Business Development
Scott is a PhD-trained molecular & cellular biologist and business development leader. He has 9 years of experience leading biotech R&D teams and 16 years in sales, business development, strategic planning, alliance management, and corporate development. Scott has supported therapeutic discovery and development across many modalities, including small molecules, biologics, cell and gene therapies, and genetic medicines. His passion for people and innovation has driven him to craft therapeutics development and manufacturing solutions that improve business efficiencies, strengthen partnerships, and promote business growth. Before joining uBriGene, Scott held leadership roles of increasing responsibility at QIAGEN, DiscoverX, FUJIFILM Cellular Dynamics Inc., Synthego, and Maravai LifeSciences.
Scott completed a postdoctoral fellowship at St Jude Children’s Research Hospital. He earned his PhD from the Indiana University School of Medicine, his Masters from Northwestern University, and his Bachelors from Purdue University.
He was formerly the SVP of Operations and Business Development at Biostem Life Sciences before assuming the roles of chairman of the scientific advisory board and a member of the Board of Directors. He is a former co-founder & Chief Technology Officer at Lacerta Therapeutics, an AAV gene therapy company developing manufacturing, capsid engineering and clinical programs for CNS disorders. He holds a B.S. in Biology & Chemistry from St. Lawrence University and a Ph.D. in Pharmacology & Experimental Therapeutics from the University of Florida.
Director of Marketing, North America
High-achieving product Marketing Director with 10+ years of progressive experience in life sciences and cell and gene therapy CDMO services, with a strong molecular and cell biology scientific background. Seeking to contribute expertise in strategic marketing, content creation, and new product launch to a leading life sciences company.
Scott completed a postdoctoral fellowship at St Jude Children’s Research Hospital. He earned his PhD from the Indiana University School of Medicine, his Masters from Northwestern University, and his Bachelors from Purdue University.
He was formerly the SVP of Operations and Business Development at Biostem Life Sciences before assuming the roles of chairman of the scientific advisory board and a member of the Board of Directors. He is a former co-founder & Chief Technology Officer at Lacerta Therapeutics, an AAV gene therapy company developing manufacturing, capsid engineering and clinical programs for CNS disorders. He holds a B.S. in Biology & Chemistry from St. Lawrence University and a Ph.D. in Pharmacology & Experimental Therapeutics from the University of Florida.
