Principal Scientist, Analytical Science and Technology (ASAT), Cell Therapy
Seattle 400 Dexter - WA, United States
USD 128K-155K Senior-level Full Time
Tasks
- Author analytical sections of regulatory submissions
- Conduct method transfer and method validation
- Design and execute laboratory experiments
- Develop and execute analytical methods and protocols
- Evaluate experimental data and identify risks
- Implement method lifecycle and maintenance programs
- Independently lead complex investigations and corrective actions
- Lead method optimization
- Mentor and coach team members
- Partner on development and qualification studies
- Perform non routine troubleshooting and problem solving
- Represent department in product review boards and regulatory inspections
- Select and characterize reagents for assays
- Write regulatory compliant reports and documentation
Perks/Benefits
- 11 Paid National Holidays
- Flexible time off
- Global shutdown between Christmas and New Years
- Paid time off
Skills/Tech-stack
Analytical method lifecycle | Bioanalytical methods | CGMP | Cell biology | Cell-based assays | Continuous Improvement | Corrective Action | Data Interpretation | ELISA | EMA regulations | EP standards | FDA Regulations | Flow Cytometry | ICH Guidelines | Instrument operation | Method optimization | Method transfer | Method validation | Molecular Biology | QPCR | Regulatory Compliance | Technical writing | USP standards | Vector characterization | Viral Vector | Viral vector characterization
Education
Roles
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