Senior Scientist, Cpv, Comparability, And Statistics

CSL SEQIRUS

Melbourne, Australia
Continued process verification (cpv)
Statistical comparability assessments
Advanced statistical methods
Lead the design, implementation, and maintenance of Continued Process Verification (CPV) programs to monitor manufacturing performance

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.
  • Purpose-driven work supporting patients worldwide and a science-led organisation with global manufacturing scale.

Matching Summary

Lead the design, implementation, and maintenance of Continued Process Verification (CPV) programs to monitor manufacturing performance.

Skills & Requirements

Must-have

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

Nice-to-have

  • Digital tools and continuous improvement
  • Cross-functional partnership
  • Science-led organization
  • Culture of continuous improvement

Key Requirements

  • Master's degree or PhD
  • 5 -10+ years' experience
  • Pharmaceutical, biotech, or regulated industries
  • Expertise in CPV and statistical analysis
  • Hands-on experience with statistical tools
  • Solid knowledge of GMP

Work Rights

Not specified

Tailored Resume

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