Senior Scientist, Cpv, Comparability, And Statistics
CSL
Continued process verification (cpv)
Statistical analysis and data interpretation
Advanced statistical methods including spc and doe
This role plays a critical part in ensuring consistent product quality and robust manufacturing performance across the product lifecycle by applying advanced data analytics in a regulated pharmaceutical environment
Job Summary
This role plays a critical part in ensuring consistent product quality and robust manufacturing performance across the product lifecycle by applying advanced data analytics in a regulated pharmaceutical environment.
CSL is a purpose-driven, science-led organization with global manufacturing scale that fosters strong collaboration across technical, quality, and manufacturing teams.
The company promotes a culture of continuous improvement, learning, and innovation while supporting patients worldwide with life-changing therapies.
Matching Summary
This role plays a critical part in ensuring consistent product quality and robust manufacturing performance across the product lifecycle by applying advanced data analytics in a regulated pharmaceutical environment.
Skills & Requirements
Must-have
Continued Process Verification (CPV)
Statistical analysis and data interpretation
Advanced statistical methods including SPC and DOE
Regulatory compliance in pharmaceutical manufacturing
Use of statistical tools such as JMP, Minitab, R, or Python
Process data trend and variability analysis
Nice-to-have
Cross-functional collaboration
Continuous improvement initiatives
Communication of complex statistical concepts
Experience with comparability studies
Digital tools for process robustness
Key Requirements
Master’s degree or PhD in Statistics, Engineering, Biostatistics or related discipline
5-10+ years experience in pharmaceutical or regulated industries
Strong expertise in CPV and statistical analysis
Hands-on experience with JMP, Minitab, R, or Python
Solid knowledge of GMP and regulatory expectations