Senior Scientist, Cpv, Comparability, And Statistics

CSL Limited

Multiple Locations
On-site
Statistical analysis and data interpretation
Continued process verification (cpv) programs
Statistical comparability assessments
CSL Limited is seeking a Senior Scientist specializing in Continued Process Verification, Comparability, and Statistics to ensure high-quality manufacturing in a regulated environment. The role involves advanced statistical analysis, collaboration across teams, and supporting regulatory submissions

Job Summary

  • Lead the design, implementation, and maintenance of Continued Process Verification (CPV) programs to monitor manufacturing performance.
  • Apply advanced statistical methods including SPC, DOE, regression, and multivariate analysis to support data-driven decisions.
  • Partner cross-functionally with MS&T, Process Development, Manufacturing, and Quality teams to support investigations, deviations, and CAPA activities.

Matching Summary

Match Score: 85

CSL Limited is seeking a Senior Scientist specializing in Continued Process Verification, Comparability, and Statistics to ensure high-quality manufacturing in a regulated environment. The role involves advanced statistical analysis, collaboration across teams, and supporting regulatory submissions.

Skills & Requirements

Must-have

  • Statistical analysis and data interpretation
  • Continued Process Verification (CPV) programs
  • Statistical comparability assessments
  • Advanced statistical methods
  • GMP and regulatory expectations

Nice-to-have

  • Process robustness improvement
  • Digital tools implementation
  • Continuous improvement initiatives

Key Requirements

  • Master’s degree or PhD in Statistics, Engineering, Biostatistics, or related
  • 5-10+ years experience in pharmaceutical, biotech, or regulated industries
  • Hands-on experience with JMP, Minitab, R, or Python
  • Experience supporting comparability studies and product lifecycle management (preferred)

Work Rights

Not specified

Tailored Resume

Cover Letter