Senior Stability Specialist, Quality Control
Core
Senior Stability Specialist responsible for coordinating stability testing, authoring reports, managing investigations, and leading quality control operations for cell therapy products.
Role type
Senior IC Quality Control Specialist (Stability)
Builds
Stability protocols, reports, and regulatory submission documents for drug products and substances
Domain
Biopharmaceuticals / Cell Therapy / Quality Control
Required skills
Stability study design and execution, Statistical analysis (Prism/JMP), OOS/OOT investigation leadership, Regulatory guidance knowledge, CGMP compliance, Laboratory equipment maintenance, CRO coordination
Preferred skills
None stated
Technologies
Prism, JMP
Responsibilities
Author, review and execute stability protocols; Assess stability data and perform statistical analyses; Lead investigations for OOS, OOT, and deviations; Coordinate sample testing with CROs; Schedule laboratory equipment maintenance
Seniority
Senior, hands-on IC