Li Sun

About Li Sun

Process development scientist with extensive hands-on and project leading experience in drug product fill/finish operations from clinical fills to commercialization including commercial process development, process characterization, product risk assessments, process validation, and tech transfers• In-depth experience in BLA filing and pre-approval inspection (PAI) from FDA, and TGA• Lead inventor of an international patent (pending) for monitoring photoexposure in real time, lead author and presenter in multiple research manuscripts and conference presentations on photostability of protein products• Diverse scientific background in pharmaceutics, biology, engineering, and mathematics with 12+ years of independent research experience• Subject matter of expert in visual inspection for parental drug products, developed inspection processes for commercial manufacturing and batch release, created and certified defect sets• Technical leader in conducting process performance qualification (PPQ) for one commercial viral formulation (filed BLA) using disposable technology and one Phase high concentration mAb formulation• Extensive experience in floor support for clinical and commercial manufacturing, developed GMP batch records and SOPs, led multiple GMP studies in support of INDs and BLAs regulatory filings• Team lead for numerous projects from technology and process development to commercial manufacturing in cross-functional environments with a strong ability to integrate business objectives in product development to achieve resource efficiency• Superior leadership and teamwork skills with managing experience, always deliver high quality results on time, authored numerous protocols, technical reports, and SOPs, purchased and owned multiple equipment with IQ/OQ/PQ• Remarkably intellectual, proactive, passionate, accountable, and resourceful

Experience

1. Scientist

   Regeneron

   Jan 2015 — Present · Tarrytown, NY, US

Education

• Peking University

  B.S., Biological Sciences, Mathematics and Applied Mathematics

  2001 — 2005

• University of Utah

  PhD, Pharmaceutics and Pharmaceutical Chemistry

  2006 — 2015

Skills

• Drug Delivery
• Pharmaceutical Industry
• Sop
• Microscopy
• Fda
• Clinical Development
• Western Blotting
• Pharmaceutics
• Drug Discovery
• Manufacturing
• Confocal Microscopy
• Hplc
• Characterization
• Gmp
• Leadership
• Uv/Vis
• Fundraising
• Validation
• Science
• Biochemistry
• Chromatography
• Molecular Biology
• Process Simulation
• Pre-Approval Inspection
• Process Validation
• Protein Chemistry
• Lifesciences
• Biotechnology
• Protein Purification
• Pharmaceutical Process Development
• Mandarin
• Project Management
• Bla
• Drug Development
• Cancer
• Biopharmaceuticals
• Formulation
• Cell Culture
• Technology Transfer
• Flow Cytometry