Advanced statistical analysis and data extrapolation
Compliance with gmp and ich guidelines
The Stability Senior Scientist ensures a robust stability program by leading complex activities and supporting junior scientists within a global team environment
Job Summary
The Stability Senior Scientist ensures a robust stability program by leading complex activities and supporting junior scientists within a global team environment.
The role involves preparing protocols, compiling data, performing statistical analyses, generating reports, and ensuring compliance with regulatory and internal standards.
CSL Behring is a global biotherapeutics leader committed to innovation, inclusion, and delivering lifesaving therapies worldwide.
Matching Summary
The Stability Senior Scientist ensures a robust stability program by leading complex activities and supporting junior scientists 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
Risk-based assessments and change control processes
Support regulatory requests and documentation
Nice-to-have
Training and technical guidance to junior scientists
Global team collaboration and coordination
Self-management with minimal supervision
Strategic alignment with departmental objectives
Proactive issue identification and resolution
Key Requirements
3+ years pharmaceutical manufacturing experience
Science degree in pharmacy, pharmaceutical technology, biology, or chemistry
Fluency in English oral and written
Experience in stability program development
Knowledge of GMP environment and biopharmaceutical product lifecycle