Tao Wei

Experience

1. Director, Cmc Analytical Development

   Sarepta Therapeutics

   Mar 2025 — Present · Bedford, MA, US

   Serve as the Analytical Development lead on cross-functional CMC team, aligning analytical strategies with regulatory expectations, program goals (siRNA, AOC, and ASO), and development milestones. Define and execute analytical control, impurity, characterization, and comparability strategies to enable robust product understanding and regulatory readiness. Lead phase-appropriate analytical method development, qualification/validation, and technology transfer to QC and external partners. Direct drug substance (DS) and drug product (DP) characterization to support regulatory submissions, lifecycle analysis, and comparability assessments. Provide technical oversights across preclinical, clinical, and commercial programs, resolving complex investigations and strengthening method robustness and reliability. Drive innovation in analytical technologies to expand capabilities for oligonucleotide therapeutics. Author and review relevant CMC Module 3 sections for IND, IMPD, and NDA submissions and lead responses to heath authority inquiries. Partner with Process Development (PD), MSAT, QC, QA, Nonclinical, and Regulatory Affairs (RA) to establish phase-appropriate DS and DP specifications. Manage and influence CDMOs, CTLs, and external partners to ensure alignment with program priorities and analytical requirements. Lead, mentor, and provide strategic direction to a team of scientists and analysts.

Education

• Beijing University of Chemical Technology

  Master's Degree, Materials Science and Engineering

  2009 — 2012

• Beijing University of Chemical Technology

  Bachelor's Degree, Polymer Science and Engineering

  2005 — 2009

• University of Michigan

  Master’s Degree, Chemical Engineering

  2012 — 2015

• University of Michigan

  Doctor of Philosophy (Ph.D.), Chemical Engineering

  2012 — 2017

Skills

• Reaction Kinetics
• Dynamic Covalent Chemistry
• Thermal Analysis
• Solid Phase Synthesis
• Ftir
• Lyophilization
• Characterization
• Gel Permeation Chromatography (Gpc)
• Uv/Vis
• Spectroscopy
• Laboratory Skills
• Polymer Chemistry
• Reaction Engineering
• Matlab
• High-Performance Liquid Chromatography (Hplc)
• Polymer Physics
• Xrd
• Uv/Vis Spectroscopy
• Centrifugation
• Chromatography
• Xps
• Dsc
• Organic Chemistry
• Fret
• Standard Operating Procedure (Sop)
• Organic Synthesis
• Analytical Skills
• Fluorescence Spectroscopy
• Mass Spectrometry
• Thermoplastics
• Self-Assembly
• Polymers
• Microsoft Office
• Peptoids/Peptides
• Analytical Chemistry
• Liquid Chromatography-Mass Spectrometry (Lc-Ms)
• Design of Experiments
• Tga
• Data Analysis
• Chemistry