Quality Control Analyst
Core
Performing cGMP quality control testing, stability program management, and analytical method support for next-generation mRNA medicines.
Role type
Senior IC quality control analyst (pharmaceutical/biotech)
Builds
Stable, compliant mRNA drug products for global patient delivery
Domain
Biopharmaceutical manufacturing / mRNA therapeutics
Required skills
HPLC/UPLC operation, UV Spectroscopy, Dynamic Light Scattering (DLS), plate reader assays, GMP compliance, stability data analysis, LIMS data entry, SOP authoring, CAPA management, equipment troubleshooting
Preferred skills
FDA/EU/ICH regulatory knowledge, method transfer/qualification experience, investigation/deviation documentation, cross-functional collaboration
Technologies
HPLC, UPLC, UV Spectroscopy, DLS, Plate Readers, LIMS
Responsibilities
Execute release and stability testing, manage stability program logistics, troubleshoot analytical methods, author GMP documentation, support regulatory inspections, drive continuous improvement
Seniority
Mid-to-Senior, hands-on IC