Scientist, QC Analytical
Core
Perform routine and non-routine Quality Control testing for cell therapy products, raw materials, and critical reagents in a GMP-regulated laboratory to evaluate identity, purity, potency, and safety.
Role type
Senior IC QC Bioanalytical Scientist
Builds
Cell therapy drug products and advanced therapy medicinal products
Domain
Biopharmaceuticals / Cell Therapy
Required skills
Flow cytometry, ddPCR/qPCR, ELISA, multiplex immunoassays, automated cell counting, cell culture, aseptic sample handling, GMP compliance, method validation, root cause analysis, data integrity (ALCOA+)
Preferred skills
Statistical analysis, assay trending, quality management systems, deviation/CAPA processes, audit readiness
Technologies
Flow cytometers, ddPCR/qPCR systems, automated cell counters, ELISA platforms, cell culture incubators
Responsibilities
Execute in-process, release, characterization, and stability testing for cell therapy programs; support method transfer, verification, and validation; investigate analytical deviations and out-of-specification results; collaborate with QA, Manufacturing, and Regulatory teams; maintain laboratory readiness and documentation compliance.
Seniority
Mid-Senior, hands-on IC