Quality Control Associate - Bioassay
Core
Perform bioassay testing for commercial and stability batches, calibrate equipment, and release results within Turnaround Time (TAT) while adhering to GMP.
Role type
Quality Control Associate (Bioassay)
Builds
Commercial and stability batches for pharmaceutical products
Domain
Biopharmaceuticals / Bioassay
Required skills
Cell-based bioassays, SPR technique, FACS techniques, cell culture techniques, Biochemical analysis (Electrophoresis, ELISA), cGMP environment experience, protein chemistry basics, bioassay method validations
Preferred skills
Biologics/Biosimilar industry knowledge, tech transfer experience
Technologies
SPR, FACS, ELISA, Electrophoresis
Responsibilities
Test samples and release data within timelines, prepare reagents and buffers, document activities per Good Documentation Practices, conduct self-checks and root cause analyses, maintain and calibrate equipment, train new team members
Seniority
Mid-level, hands-on IC