Scientist (m/f/x) CPV, Comparability, and Statistics — CSL Behring
NewCHF 49'500 - 75'000
CSL Behring · Bern (BE)
- Location
- Bern
- Contract
- full-time
- Posted
- Yesterday
SalaryCHF 49'500 - 75'000
Role overview
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.
- 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.
- Your Responsibilities:
Main responsibilities
- Your Responsibilities:
Application process
- 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:
Additional details
- Apply advanced statistical methods including SPC, DOE, regression, and multivariate analysis to support data driven decisions