Associate Scientist II, Clinical QC – Immunology Analytical Development and Clinical QC

Execute experiments for GMP stability and release testing for rare disease biotherapeutics, supporting early-stage through PIII biologics manufacturing. Perform cGxP-compliant analytical testing using plate-based assays, including residual impurity, potency/activity binding, and compendial tests for in-process, drug substance, and drug product samples. Write and review SOPs, validation/qualification protocols and reports, maintain accurate lab records in notebooks/LIMS, and support global QC work with ~5–10% travel.