Senior Scientist, CPV, Comparability, and Statistics

CSL

4d

About The Position

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

Requirements

• 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

Nice To Haves

• Experience supporting comparability studies and product lifecycle management

Responsibilities

• 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

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1,001-5,000 employees