Xiangkun Yang

About Xiangkun Yang

EXPERIENCES AND SKILLS• 7.5+ years of FDA/industry experience in analytical control strategies and analytical characterization with mAbs, bispecifics, ADCs, oligonucleotides, peptides, bioconjugates, and cell & gene therapies.• Lead all aspects of CMC analytical development including develop/execute analytical strategies, identify CQAs, method development/qualification/validation, provide justification of specification, stability programs, method transfer, risk assessment/investigation, etc.• Support preclinical to different clinical stages of drug development, including developability assessment, lead candidate selection, process development, formulation development, manufacturing, regulatory submissions, commercial product comparability, etc.• Experience as Analytical Lead for a mAb program; Drug Substance (DS) Analytical Lead for an LNP program.• Author module 3 sections in regulatory filings, address questions from agencies. Supported 4 successful IND submissions (2 mAb programs, 1 ADC program and 1 genome editing program).• Team leader managing multiple associate/junior/senior scientists. Define resource needs to ensure project success.• Supervise CRO/CDMO/CTL analytical activities including technology transfer, troubleshooting, document approval and GMP release/stability testing.• Extensive hands-on experience with various analytical techniques including HPLC, LC-MS(/MS)(intact mass, top-down, bottom-up), DDA/MRM/PRM, peptide mapping, IP-RP, SEC, HILIC, CE, UV-Vis, fluorescence, SDS-PAGE, Western blot, etc.• Proficient with bioanalysis, e.g. immunoprecipitation and affinity enrichment for biomarker and PK/ADME studies with LC-MS/MS.• Familiarity with FDA/EMA/ICH guidelines; keep close tracking of industry, regulatory and technical trends.

Experience

1. Principal Research Scientist i, Team Leader

   AbbVie

   Jul 2025 — Present · Worcester, MA, US

   Analytical Project Lead for late-stage biologics programs.

Education

• Sichuan University

  Bachelor of Science (B.S.), Pharmacy

  2007 — 2011

• The University of Georgia

  Doctor of Philosophy (Ph.D.), Pharmaceutical Analysis, Analytical Chemistry

  2013 — 2017

Skills

• Protein Posttranslational Modification
• Lc-Ms
• Research
• Life Sciences
• Western Blotting
• Metabolomics
• Proteomics
• Drug Metabolism
• Uv/Vis
• Molecular Biology
• High-Performance Liquid Chromatography (Hplc)
• Toxicology
• Biotechnology
• Polymerase Chain Reaction (Pcr)
• Mass Spectrometry
• Biochemistry
• Ptm Identification