Frank Fei

Background

About Frank Fei

Pharmaceutical professional with extensive experience in bioanalytical research, project management, and client services with strong expertise in mass spectrometry in support of drug discovery, preclinical, and clinical development. Well-versed with various hyphenated tandem mass spectrometry and chromatographic separation techniques (HPLC, UPLC) for the quantitative and qualitative analyses of biopharmaceuticals/pharmaceuticals, proteins, nucleic acids, and glycosphingolipid biomarkers in complex biological matrices and tissues. Expertise in: Quantitative bioanalytical/biomarker method development, validation, and biological sample analysis, API drug substance, drug product analyses using immune-affinity capture, solid-phase extraction, liquid-liquid extraction, protein precipitation as purification/enrichment methods for sample preparation Identified and characterized biomarkers or drug compounds by peptide mapping, MS/MS de novo sequencing, acid/base hydrolysis, forced heat degradation in conjunction with various high-resolution/high accurate mass spectrometers, such as QTOF, Orbitrap Managed multiple projects, reviewed and approved bioanalytical data/reports, and served as Principal Investigator for GLP regulated studies in support of drug research and development Provided guidance on analytical issues and regulatory requirements (GXPs) internally or externally. Communicated effectively with clients, team members, and internal key stakeholders