Quality Control Scientist - Microbiology, Bioanalytical
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
Quality Control Scientist (Microbiology/Bioanalytical)
Builds
Cell therapy drug products and advanced therapy medicinal products (ATMPs)
Domain
Biopharmaceuticals / Cell Therapy
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
flow cytometry, ddPCR/qPCR, ELISA, multiplex immunoassays, automated cell counting, cell culture, aseptic sample handling, GMP compliance, method validation, root cause analysis
Preferred skills
statistical analysis, assay trending, quality management systems, deviation management, audit readiness
Technologies
flow cytometers, ddPCR/qPCR systems, automated cell counters, ELISA platforms, cell culture incubators
Responsibilities
Execute analytical methods for identity, phenotype, purity, and characterization; support method transfer and validation; investigate assay failures and out-of-specification results; collaborate with QA, Manufacturing, and Regulatory teams; maintain laboratory readiness and data integrity.
Seniority
Mid-level, hands-on IC
