Senior Scientist, CPV, Comparability, and Statistics

At CSL, we're committed to delivering life-changing therapies with the highest standards of quality, safety, and reliability. We're seeking a Senior Scientist Continued Process Verification (CPV) Comparability & Statistics to play a critical role in ensuring consistent product quality and robust manufacturing performance across the product lifecycle., * Lead the design, implementation, and maintenance of Continued Process Verification (CPV) programs to monitor manufacturing performance

• Analyse process data to identify trends, variability, and potential process drift
• Define, monitor, and interpret critical quality attributes (CQAs) and key process parameters
• Lead statistical comparability assessments to support process and product changes such as scale-up, site transfers, or optimisation activities
• Apply advanced statistical methods including SPC, DOE, regression, and multivariate analysis to support data-driven decisions
• Contribute to regulatory submissions and provide statistical justification during audits and inspections
• Partner cross-functionally with MS&T, Process Development, Manufacturing, and Quality teams to support investigations, deviations, and CAPA activities
• Identify opportunities to improve process robustness through advanced analytics, digital tools, and continuous improvement initiatives, * Purpose-driven work supporting patients worldwide
• A science-led organisation with global manufacturing scale
• Strong collaboration across technical, quality, and manufacturing teams
• Opportunities to apply advanced analytics to real-world manufacturing challenges
• A culture of continuous improvement, learning, and innovation

Apply now and help ensure robust, compliant, and high-quality manufacturing processes that make a difference to patients around the world.

• A Master's degree or PhD in Statistics, Engineering, Biostatistics, or a related discipline
• 5 -10+ years' experience in pharmaceutical, biotech, or other regulated industries
• Strong expertise in CPV, statistical analysis, and data interpretation
• Hands-on experience with statistical tools such as JMP, Minitab, R, or Python
• Solid knowledge of GMP and regulatory expectations
• Experience supporting comparability studies and product lifecycle management (preferred)
• The ability to communicate complex statistical concepts clearly to cross-functional stakeholders

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.