Senior Scientist, Biostatistics, CPV – MSAT
Tasks
- Establish predictive process monitoring analytics
- Evaluate statistical alert events
- Identify operational excellence opportunities using data driven evaluations
- Maintain site statistical process control program
- Monitor and trend CPV parameters
- Perform multivariate analysis modeling
- Review and approve site documents for CPV and APQR
- Support CPV and APQR reporting
- Support investigations with data and analysis
- Support regulatory inspection readiness
Perks/Benefits
Skills/Tech-stack
Annual Product Quality Review | Automation coding | Biopharmaceutical regulations | CGMP | Cell therapy | Closed systems | Cold Chain | Continuous Process | Continuous process verification | Cryogenic Technologies | Data Analysis | JMP | Lean Manufacturing | Minitab | Multivariate analysis | Operational excellence | Predictive Analytics | Process Verification | Process control | Python | Quality review | R | SAS | Single-use technologies | Statistical Alert Events | Statistical Process Control
Education
Bachelor of Engineering | Bachelor of Science | Master of Science | PhD
Roles
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