Associate Director, Analytical Development and Clinical QC
Core
Lead late-stage analytical development and clinical QC strategy for biologics programs, overseeing method validation, transfer, and regulatory filings.
Role type
Senior IC analytical development and clinical quality control lead
Builds
Analytical control strategies, validated methods, and regulatory submissions for late-stage biologics
Domain
Biopharmaceuticals / Biologics
Required skills
Monoclonal antibodies, bispecifics, fusion proteins, chromatography (SEC, RP, IEX), capillary electrophoresis, spectroscopy, bioassays, residuals/impurities testing, ICH guidelines, GMP/GLP compliance, CTD Module 3 authoring, OOS/OOT handling, deviation/CAPA management, QbB
Preferred skills
Microbiology assays, CDMO/CRO oversight, ICH stability programs, extended characterization, LIMS, ELN, data visualization, AI tools, statistical software (JMP), team mentoring