QC Senior/Principal Scientist, Analytical Method Validation
Tasks
- Assess analytical method system suitability
- Coach QC scientists
- Coordinate critical material qualification
- Develop technical training materials
- Generate cGMP documentation
- Interface with clients for technical requirements
- Lead continuous improvements
- Lead instrument qualification in cGMP
- Lead method protocol and report development
- Maintain laboratory procedures
- Monitor analytical method performance
- Optimize analytical methods
- Perform statistical analyses of validation data
- Present technical findings to cross functional teams
- Qualify analytical methods
- Support OOS investigations
- Support QC data analysis
- Support change control investigations
- Support deviations investigations
- Support onboarding of instruments
- Train on analytical methods
- Transfer analytical methods
- Troubleshoot assay performance
- Validate analytical methods
Perks/Benefits
- 401k match
- Accidental death and dismemberment insurance
- Dental insurance
- Disability insurance
- FSA
- HSA
- Healthcare plans
- Observed holidays
- Paid sick time
- Paid vacation
- Term life insurance
- Vision insurance
Skills/Tech-stack
Analytical Data | Analytical data trending | Analytical method system suitability | Analytical method validation | Bioassay development | CE-SDS | CGMP | Cell-based bioassays | Critical material qualification | Data trending | DdPCR | ELISA | GLP | HPLC | JMP | LIMS | MS Excel | MS Word | Material qualification | Method qualification | Method transfer | Method validation | Minitab | Potency assay | QPCR | Quality Systems | SDS-PAGE | Statistical Analysis | System suitability | Vector Manufacturing | Viral Vector | Viral vector manufacturing | Viral vector testing | Western blot
Education
Regions
Countries
States
Cities
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