Scientist III, Analytical Development and Clinical QC
Core
Lead analytical development and clinical QC for late-stage biologics programs from Phase 3 through commercialization, managing method validation, transfer, and regulatory filings.
Role type
Senior IC analytical scientist (biologics)
Builds
Control strategies, validated analytical methods, and regulatory submissions for monoclonal antibodies and fusion proteins
Domain
Biopharmaceuticals / Analytical Chemistry
Required skills
Monoclonal antibody/bispecific/fusion protein analysis, chromatography (SEC, RP, IEX), capillary electrophoresis (CE-SDS, cIEF), spectroscopy (UV/Vis, fluorescence, CD), bioassays, residuals/impurities testing, compendia method verification (USP/EP/JP), ICH guidelines (Q5E, Q6B, Q8–Q12), GMP/GLP compliance, CTD Module 3 authoring, OOS/OOT handling, deviation/CAPA management, QbD, critical quality attributes definition
Preferred skills
Statistical data analysis, CDMO/CRO oversight, stability program modeling, forced degradation studies, digital lab systems (LIMS, ELN, Chromatography Data Systems), AI tools
Technologies
SEC, RP, IEX, CE-SDS, cIEF, UV/Vis, fluorescence, CD, LIMS, ELN, JMP
Responsibilities
Lead analytical method validations, transfers, and compendia method verifications; Develop and implement analytical end-to-end strategies for late-stage biologics programs; Author regulatory submissions for clinical and commercial markets; Lead analytical QC testing, troubleshooting, and data analysis
Seniority
Senior, hands-on IC