Principal Scientist, Analytical Science and Technology (ASAT), Cell Therapy
Seattle 400 Dexter - WA, United States
USD 124K-155K Senior-level Full Time
Tasks
- Author analytical sections for regulatory submissions
- Collaborate on cross-functional teams
- Conduct method transfer
- Design and execute laboratory experiments
- Develop methods and protocols
- Evaluate experimental data
- Execute method validation
- Identify risks and impact
- Implement method lifecycle programs
- Lead complex investigations
- Lead method optimization
- Maintain analytical methods
- Mentor and coach team members
- Partner on development and qualification studies
- Represent department in product review boards
- Respond to health authority questions
- Select and characterize reagents
- Support regulatory inspections and audits
- Troubleshoot non routine issues
- Write regulatory documents
Perks/Benefits
- 401k plan
- Dental insurance
- Disability insurance
- Employee assistance program
- Flexible time off
- Identity theft protection
- Legal support
- Life insurance
- Medical insurance
- Paid time off
- Vision insurance
- Wellbeing programs
Skills/Tech-stack
AAV vectors | Analytical Methods | Bioanalytical methods | CGMP | Cell biology | Cell therapy | Cell therapy analytical methods | Cell-based assays | ELISA | Flow Cytometry | Instrument standardization | Lentiviral vectors | Lifecycle Management | Method Lifecycle Management | Method optimization | Method transfer | Method validation | Molecular Biology | QPCR | Quality Control | Regulatory Compliance | Scientific writing | Troubleshooting | Vector characterization | Viral Vector | Viral vector characterization | Viral vector quality control
Education
Bachelor of Engineering | Bachelor of Science | Master of Science
Roles
Analytical Scientist | Principal | Principal Scientist | Scientist
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