Senior Scientist, Cpv, Comparability, And Statistics

CSL SEQIRUS

Continued process verification (cpv) programs
Statistical comparability assessments
Advanced statistical methods
This role sits at the intersection of statistics, manufacturing science, and regulatory compliance, applying advanced data analytics to support decision‑making, process understanding, and continuous improvement in a regulated pharmaceutical environment

Job Summary

  • This role sits at the intersection of statistics, manufacturing science, and regulatory compliance, applying advanced data analytics to support decision‑making, process understanding, and continuous improvement in a regulated pharmaceutical environment.
  • Lead the design, implementation, and maintenance of Continued Process Verification (CPV) programs to monitor manufacturing performance and lead statistical comparability assessments to support process and product changes.
  • Purpose‑driven work supporting patients worldwide, a science‑led organisation with global manufacturing scale, and strong collaboration across technical, quality, and manufacturing teams.

Matching Summary

This role sits at the intersection of statistics, manufacturing science, and regulatory compliance, applying advanced data analytics to support decision‑making, process understanding, and continuous improvement in a regulated pharmaceutical environment.

Skills & Requirements

Must-have

  • Continued Process Verification (CPV) programs
  • statistical comparability assessments
  • advanced statistical methods
  • SPC, DOE, regression, and multivariate analysis
  • GMP and regulatory expectations
  • data analytics for decision-making

Nice-to-have

  • digital tools for process improvement
  • science-led organization
  • culture of continuous improvement
  • cross-functional collaboration

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

Work Rights

Not specified

Tailored Resume

Cover Letter