Experience

Neurophth Therapeutics / 纽福斯生物科技有限公司

• China
• Biotechnology Research
• 1 - 100 Employee

• Co-Founder, Chief Technical Operations Officer

  • May 2020 - 3 years 8 months

  Boston, Massachusetts, United States

• Co-Founder, Chief Executive Officer

  • Jan 2019 - May 2020

  Wuhan(China), Shanghai(China), Suzhou(China), Boston(USA) Developing AAV-gene therapy product candidates for the treatment of life-threatening or chronically deliberating rare diseases: - NFS-01 G11778A mutation in the NADH dehydrogenase subunit 4 complex I (ND4)-mediated Leber's hereditary optical neuropathy (LHON) - NFS-02 G3460A mutation in the NADH dehydrogenase subunit 1 complex I (ND1)-mediated Leber's hereditary optical neuropathy (LHON) - NFS-10 Anti-vascular endothelial growth factor for diabetic macular edema (DME) - NFS-04… Show more Developing AAV-gene therapy product candidates for the treatment of life-threatening or chronically deliberating rare diseases: - NFS-01 G11778A mutation in the NADH dehydrogenase subunit 4 complex I (ND4)-mediated Leber's hereditary optical neuropathy (LHON) - NFS-02 G3460A mutation in the NADH dehydrogenase subunit 1 complex I (ND1)-mediated Leber's hereditary optical neuropathy (LHON) - NFS-10 Anti-vascular endothelial growth factor for diabetic macular edema (DME) - NFS-04 (undisclosed gene) for glaucoma - NFS-05 (undisclosed gene) for autosomal dominant optic atrophy - NFS-07 (undisclosed gene) for Bietti crystalline dystrophy - NFS-09 undisclosed ocular disease - Undisclosed non-ophthalmology disease



CATUG Biotechnology

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Board Member

  • Dec 2021 - Oct 2023

  Suzhou (China), Boston (Massachusetts)



Charles River Laboratories

• United States
• Biotechnology Research
• 700 & Above Employee

• Associate Director, upstream PD and GMP manufacturing

  • Feb 2018 - Dec 2018

  Vigene Biosciences Provide operational leadership and expertise for upstream PD and GMP production of Master Cell Bank, Master Virus Bank and clinical viral vectors for gene and cell therapy. • Integrate product, process, and regulatory requirements with budget and timing constraints to optimize organizational structures and efficiencies to achieve quality, capacity, and COGS targets. • Ensure upstream production activities in compliance with cGMP while developing, implementing, and continuously… Show more Provide operational leadership and expertise for upstream PD and GMP production of Master Cell Bank, Master Virus Bank and clinical viral vectors for gene and cell therapy. • Integrate product, process, and regulatory requirements with budget and timing constraints to optimize organizational structures and efficiencies to achieve quality, capacity, and COGS targets. • Ensure upstream production activities in compliance with cGMP while developing, implementing, and continuously improving manufacturing systems and functions. • Supports GMP facility design, equipment procurement/fitting and CapEx management. • Support QA for raw material and equipment qualification, product disposition, exceptions (deviation, CAPA, OOS), change control and risk management. • Draft CMC section for regulatory filings and communications. Show less



Pfizer

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Senior Scientist- Gene Therapy PD and Tech Transfer

  • 2015 - 2018

  Greater St. Louis Area Upstream technology lead for gene therapy projects. Responsibilities included cell culutre process development for IND-enabling and late-stage projects, scaling-up and tech transfer to GMP manufacturing, regulatory filing support,overseeing CMO process development and GMP readiness activities.



The National Institutes of Health

• United States
• Biotechnology Research
• 700 & Above Employee

• Postdoctoral Research Fellow

  • 2015 - 2015

  Bethesda Technology transfer. * Conducting prior art research and patent application. * Pursuing out-licensing with biotechnology companies and drafting technology transfer protocols.

• Research Fellow- Biotechnology Core Facility & National Center for Advancing Translational Sciences

  • 2011 - 2015

  Bethesda •Led cell line, cell culture and purificaiton process development for manufacturing of biologics: mAb fusion protein, membrane protein, live virus vaccine and recombinant viral vectors. •Initiated and led High-Throughput Screening of microRNA and siRNA libraries(RNAi) for improved recombinant protein production.



Center for Drug Evaluation, China Food and Drug Administration

• Management consultanting intern

  • 2014 - 2014

  Beijing City, China Worked with consulting firms on Quality Management System design and Good Review Practices implementation.