Quality Control Scientist
Core
Develop, optimize, characterize, and validate QC assays (bioassays, ELISA) and automate workflows to ensure data integrity and regulatory compliance.
Role type
Quality Control Scientist (IC)
Builds
Automated bioassay and ELISA workflows for pharmaceutical/biotech product release and stability testing
Domain
Biopharmaceuticals / Analytical Chemistry
Required skills
ELISA, bioassays, assay development, method validation, GMP, regulatory guidelines (ICH Q2, USP), statistical analysis, troubleshooting, documentation (ALCOA+)
Preferred skills
automation scripting (Hamilton, Tecan, Beckman Biomek, Agilent Bravo), LIMS/ELN, cGMP/ICH/FDA/EMA requirements
Technologies
Hamilton, Tecan, Beckman Biomek, Agilent Bravo, LIMS, ELN
Responsibilities
Develop and validate QC assays; design and qualify automated workflows; lead assay transfers to QC/external partners; establish product specifications; support release/stability testing; troubleshoot deviations/OOS/OOT; review technical reports; train analysts
Seniority
Scientist, hands-on IC
