Senior Scientist, CPV, Comparability, and Statistics
APAC, AU, Broadmeadows, CSL Behring, Australia
AUD 118K-124K (estimate) Senior-level Full Time
Tasks
- Analyze process data for trends variability drift
- Apply SPC DOE regression multivariate analysis
- Define monitor interpret CQAs and key process parameters
- Improve process robustness using advanced analytics digital tools continuous improvement
- Lead CPV program design implementation maintenance
- Lead statistical comparability assessments
- Partner with cross functional teams for investigations deviations CAPA
- Support regulatory submissions statistical justification
Perks/Benefits
- Continuous improvement culture
- Cross-functional collaboration
- Learning and innovation opportunities
- Purpose-driven work
Skills/Tech-stack
Continued Process Verification | Critical Quality Attributes | Data analytics | Design of Experiments | GMP | JMP | Minitab | Multivariate analysis | Process Verification | Process control | Python | Quality attributes | R | Regression Analysis | Statistical Process Control
Education
Roles
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