QC Analyst - Bioassay
Core
Conducting quality control tests on in-process, release, stability, and research samples using cell-based potency and ELISA techniques.
Role type
QC Analyst (Bioassay)
Builds
Quality data and compliant test results for biotherapeutic development
Domain
Biopharmaceuticals / Cell Biology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cell-based potency testing, ELISA, mammalian cell culture, reagent preparation, SOP writing, instrument calibration, data review, regulatory compliance
Preferred skills
LIMS, ViCell, SoftMax, Hamilton Venus, Labware
Responsibilities
Conducting tests on in-process, release, stability, and research samples; Gathering data and documenting test results for cell-based potency and ELISA; Performing mammalian cell culture and preparing reagents; Reviewing test results for compliance and reporting anomalies; Calibrating or verifying instruments; Writing and revising control test procedures and SOPs; Assisting in method validation and R&D transfer
Seniority
Individual Contributor
