Senior Principal Scientist, Drug Product Analytical Science and Technology (ASAT), Cell Therapy
Seattle 400 Dexter - WA, United States
USD 152K-185K Senior-level Full Time
Tasks
- Ensure compliance with regulatory requirements
- Evaluate experimental data and recommend course corrections
- Execute method transfer and validation
- Hire mentor and develop personnel
- Implement method lifecycle and maintenance programs
- Lead molecular biology method optimization
- Partner on development and qualification study design
- Provide technical leadership for viral vector and cell therapy methods
- Represent department in product review boards
- Represent organization in cross functional cross site teams
- Select and characterize reagents
- Support commercial QC analytical methods investigation and remediation
- Support regulatory inspections and audits
- Troubleshoot non routine complex analytical issues
- Write regulatory analytical sections and responses
Perks/Benefits
- 401k plan
- Dental insurance
- Employee assistance program
- Flexible work schedule
- Global shutdown
- Health insurance
- Life insurance
- Long-term disability
- Paid time off
- Short-term disability
- Travel protection
- Vision insurance
- Volunteer days
Skills/Tech-stack
AAV vectors | Analytical Methods | Analytical science | Bioanalytical methods | CGMP | Cell-based assays | Data Analysis | ELISA | EMA regulations | EP standards | FDA Regulations | Flow Cytometry | ICH Guidelines | Lentiviral vectors | Method transfer | Method validation | Molecular Biology | QC Analytical Methods | Scientific Data | Scientific Data Analysis | Technical Presentation | Technical writing | USP standards | Vector characterization | Viral Vector | Viral vector characterization
Education
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