Scientist, QC Analytical
Core
Perform analytical testing (assays, ELISA, qPCR, HPLC, etc.) for GMP manufacturing of gene therapies and vaccines.
Role type
QC Analytical Scientist
Builds
Release and stability testing data for raw materials, components, and finished products
Domain
Biopharmaceuticals / Gene Therapies
Required skills
cGMP laboratory experience, biochemistry, SOP writing, data documentation, statistical analysis, instrumentation troubleshooting
Preferred skills
ELISA, qPCR, ddPCR, HPLC, Capillary Electrophoresis
Technologies
ELISA, qPCR, ddPCR, HPLC, Capillary Electrophoresis
Responsibilities
Perform assays (ELISA, DNA/RNA extraction, gel electrophoresis, qPCR, ddPCR, HPLC, Capillary Electrophoresis, Appearance, Osmo, pH); Document testing in compliance with GMP/GDP procedures; Generate internal and external documents (assay protocols, summary reports, SOPs); Support release and stability testing for raw materials, components, standards, and finished products; Review laboratory work and approve data packages; Maintain and troubleshoot instrumentation; Write laboratory investigations, OOS reports, deviations, CAPAs, and perform statistical analysis and trending; Review paper and electronic records for accuracy and compliance.
Seniority
Mid-level, hands-on IC
