Advanced statistical analysis and data extrapolation
Compliance with gmp and ich guidelines
The Stability Senior Scientist ensures a robust stability program, supports regulatory requests, and leads continuous improvement activities within a global team environment
Job Summary
The Stability Senior Scientist ensures a robust stability program, supports regulatory requests, and leads continuous improvement activities within a global team environment.
This role involves preparing protocols, compiling data, performing advanced statistical analysis, generating stability reports, and escalating issues promptly.
CSL Behring is a global biotherapeutics leader committed to innovation and inclusion, operating one of the world’s largest plasma collection networks and serving patients worldwide.
Matching Summary
The Stability Senior Scientist ensures a robust stability program, supports regulatory requests, and leads continuous improvement activities within a global team environment.
Skills & Requirements
Must-have
Stability program development and management
Advanced statistical analysis and data extrapolation
Compliance with GMP and ICH guidelines
Use of electronic systems like LIMS and Statistica
Coordination with QC Operations
Risk-based assessments and change control
Nice-to-have
Training and technical guidance to junior scientists
Strategic alignment with departmental objectives
Global team collaboration
Self-management and initiative
Fluency in English communication
Key Requirements
3+ years pharmaceutical manufacturing experience
Science degree in pharmacy, pharmaceutical technology, biology, or chemistry
Good grasp of biopharmaceutical stability regulations
Experience in global biotech or pharmaceutical GMP environment