QC Analyst II
Core
Perform analytical and immunochemical testing to support the clinical manufacturing of biologics drug substance and drug product.
Role type
Senior IC QC Analyst (Biologics)
Builds
Clinical-stage biologics drug substance and drug product
Domain
Biotechnology / Biologics Manufacturing
Required skills
GMP compliance, analytical testing (UPLC, CE-SDS, icIEF, ELISA, qPCR, UV-Vis), method qualification/validation, stability testing, root cause analysis, LIMS, data integrity
Preferred skills
Cell-based methods, Empower, chromatography data systems
Technologies
UPLC, CE-SDS, icIEF, ELISA, qPCR, UV-Vis, LIMS, Empower
Responsibilities
Perform analytical and immunochemical testing per GMP; Plan and execute release, stability, and raw material testing; Develop and qualify GxP analytical methods; Troubleshoot analytical issues and support investigations; Author and revise QC documentation; Collaborate with cross-functional teams; Mentor junior analysts
Seniority
Mid-Senior, hands-on IC
