Scientist (m/f/x) CPV, Comparability, and Statistics

Responsibilities

• 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
• perform statistically robust analysis to support the update of process monitoring limits
• perform statistical comparability assessments to support process and product changes such as scale up, site transfers, or optimization activities
• Identify opportunities to improve process robustness through advanced analytics, digital tools, and continuous improvement initiatives
• Contribute to regulatory submissions and provide statistical justification during audits and inspections
• Analyze process data to identify trends, variability, and potential process drift
• support of Continued Process Verification (CPV) programs to monitor manufacturing performance
• Your Skills and Experience:
• A Master's degree or PhD in Statistics, Engineering, Biostatistics, or a related discipline
• Strong expertise in 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
• About CSL Behring
• 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.
• To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/ .

Benefits

Additional Information

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 (m/f/x) 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.

Your Match

How well this role fits your profile.

Company Intel

What employees say

Worked at CSL? Share your experience