Senior Scientist, Cpv, Comparability, And Statistics
CSL SEQIRUS
Multiple Locations
On-site
Continued process verification (cpv) programs
Statistical comparability assessments
Advanced statistical methods
CSL Seqirus is seeking a Senior Scientist in Continued Process Verification (CPV), Comparability, and Statistics to enhance product quality and manufacturing performance. The role requires advanced statistical analysis and collaboration across various teams in a regulated pharmaceutical environment
Job Summary
Lead the design, implementation, and maintenance of Continued Process Verification (CPV) programs to monitor manufacturing performance.
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.
Matching Summary
Match Score: 85
CSL Seqirus is seeking a Senior Scientist in Continued Process Verification (CPV), Comparability, and Statistics to enhance product quality and manufacturing performance. The role requires advanced statistical analysis and collaboration across various teams in a regulated pharmaceutical environment.
Skills & Requirements
Must-have
Continued Process Verification (CPV) programs
statistical comparability assessments
advanced statistical methods
GMP and regulatory expectations
data-driven decisions
Nice-to-have
product lifecycle management
digital tools
continuous improvement initiatives
science-led organization
Key Requirements
Master’s degree or PhD in Statistics, Engineering, Biostatistics, or related
5 -10+ years’ experience in pharmaceutical, biotech, or regulated industries
Hands-on experience with JMP, Minitab, R, or Python