Wenzhe Fan

About Wenzhe Fan

16 years of experience in the pharmaceutical industry under a cGMP environment. Good understanding of cGMP, ICH, FDA, and DEA regulations and guidelines. • Extensive hands-on experience in phase-appropriate analytical method development, validation, and transfer for both drug substance and drug product, including establishment of specifications, stability studies, and quality control strategies. • Experience in project management, working with cross-functional teams, and providing oversight to CRO/CMO partners during the development and validation of pharmaceutical manufacturing processes. • Proficient in writing and reviewing method procedures, validation protocols/reports, stability reports, SOPs, and analytical sections of regulatory submission documents. • Broad knowledge and extensive experience in various analytical techniques and instruments (HPLC, UPLC, GC, LC-MS, GC-MS, IC, SEC-MALS, TGA, DSC, FTIR, UV, KF titration, particle size analyzer, polarimetry, dissolution, stability testing, etc.) for analytical development. • Strong interpersonal communication, collaboration, and problem-solving skills. • Highly organized, detail-oriented, and self-motivated team player with a friendly personality.

Experience

1. Associate Director, Analytical Sciences

   Nuvalent, Inc.

   Jan 2023 — Present · Boston, MA, US

Education

• University of New Hampshire

  PhD, Analytical Chemsitry, Advisor: Professor Rudolf Seitz

  1998 — 2003

Skills

• Chromatography
• Formulation
• Nanoparticles
• Lc-Ms
• Nanotechnology
• Drug Delivery
• Validation
• Fluorescence Spectroscopy
• Gas Chromatography
• Pharmaceutical Industry
• Chemistry
• Nanomaterials
• Hplc
• Polymers
• Method Development
• Uv/Vis
• Raw Materials
• Cell
• Analytical Chemistry