Advanced statistical analysis and data extrapolation
Compliance with gmp and ich guidelines
The Stability Senior Scientist plays a key role in ensuring a robust stability program and supports regulatory requests while working within a global team environment
Job Summary
The Stability Senior Scientist plays a key role in ensuring a robust stability program and supports regulatory requests while working within a global team environment.
This position involves preparing protocols, compiling data, performing advanced statistical analysis, generating stability reports, and leading investigations into stability-related deviations.
CSL is a global biotherapeutics leader committed to innovation and inclusion, offering a diverse workforce and a culture that fosters curiosity and empathy.
Matching Summary
The Stability Senior Scientist plays a key role in ensuring a robust stability program and supports regulatory requests while working 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 LIMS and Statistica electronic systems
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
Self-management and initiative in global environment
Cross-functional collaboration
Fluency in English communication
Key Requirements
3+ years pharmaceutical manufacturing experience
Science degree in pharmacy, pharmaceutical technology, biology, or chemistry
Good understanding of product lifecycle management in GMP environment
Fluency in English
Knowledge of regulatory requirements for biopharmaceutical stability