Sr. Statistician – Chemistry, Manufacturing, and Controls (CMC)
USD 126K-199K Senior-level Full Time
Tasks
- Conduct root cause analysis and confirmation studies
- Conduct statistical analysis for manufacturing data
- Create auditable statistical analysis documentation
- Design and analyze experiments using Design of Experiments
- Develop statistical models for degradation and shelf life estimation
- Establish Statistical Process Control monitoring
- Perform multivariate analysis and simulation for risk assessment
- Perform stability and shelf life data analysis
- Prepare statistical content for Chemistry Manufacturing and Controls documentation
- Support Continued Process Verification for Critical Quality Attributes and Critical Process Parameters
- Troubleshoot Out of Specification and Out of Trend results
Perks/Benefits
Skills/Tech-stack
Analysis of Covariance | Analysis of Variance | Bayesian statistics | Capability analysis | Cell Culture | Comparability studies | Component analysis | Continued Process Verification | Control Charts | DPCR | Design of Experiments | ELISA | Equivalence Testing | Good manufacturing practices | HPLC | International Council for Harmonisation ICH | JMP | Machine Learning | Mammalian cell culture | Manufacturing practices | Minitab | Mixed-effects | Mixed-effects models | Monte Carlo | Monte Carlo Simulation | Non-inferiority testing | PLS | Plaque Assay | Principal Component Analysis | Process Verification | Process control | Process validation | QPCR | R | Regression Analysis | Response surface methodology | SAS | SAS language | Statistical Process Control | Statistics | TCID50 | Tolerance Interval | Tolerance Intervals | UPLC | Yeast fermentation
Education
Roles
Regions
Countries
States
Cities
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