Ph.D. Chemist specializing in cutting-edge Analytical Development. Proven expertise in leading LCMS method development and validation for therapeutic modalities like small molecules, oligonucleotides, peptides, antibodies, and conjugates. Adept in mass spectrometry, performing precise structure elucidation of DS/DP impurities. Renowned for project accountability and seamless execution of Analytical Development CMC deliverables. Experience with regulatory filings
AREAS OF EXPERTISE
Analytical Chemistry
Analytical Method Development and Validation
Antibody Drug Conjugate Characterization
Biochemistry
Cheminformatics
Chemistry Manufacturing Control (CMC)
Computational Chemistry
Drug Substance/Product Characterization
FT-IR/UV Spectroscopy
Good Manufacturing Practices (GMP)
High-Performance Liquid Chromatography (HPLC)
International Council for Harmonization Guidelines Compliance
Mass Spectrometry Method
Oligonucleotide Drug Substance Characterization
Organic Chemistry
Physical Chemistry
Polymer Chemistry
Process Analytical Chemistry
Regulatory Filings
Scientific Communication
Standard Operating Procedures Implementation
Structure Elucidation
Small Molecules
Technical Writing