Senior Scientist, Cpv, Comparability, And Statistics

CSL

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Continued process verification (cpv) programs
Statistical comparability assessments
Advanced statistical methods
** CSL is seeking a Senior Scientist specializing in Continued Process Verification (CPV), Comparability, and Statistics to ensure product quality and improve manufacturing performance. The role combines expertise in statistics, data analytics, and regulatory compliance within a biopharmaceutical environment. **

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: 75

** CSL is seeking a Senior Scientist specializing in Continued Process Verification (CPV), Comparability, and Statistics to ensure product quality and improve manufacturing performance. The role combines expertise in statistics, data analytics, and regulatory compliance within a biopharmaceutical environment. **

Skills & Requirements

Must-have

  • Continued Process Verification (CPV) programs
  • statistical comparability assessments
  • advanced statistical methods
  • GMP and regulatory expectations
  • cross-functional collaboration

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

Work Rights

Not specified

Tailored Resume

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