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EMEA, CH, Kanton Bern, Bern, CSL Behring, Switzerland
Onsite
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 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
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.
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/.
Our Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
You Belong at CSL
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.