Senior Scientist, Drug Product Analytical Science And Technology (ASAT), Cell Therapy
Seattle 400 Dexter - WA, United States
USD 108K-144K Senior-level Full Time
Tasks
- Author analytical sections of regulatory submissions
- Author revise and review test methods SOPs trend reports and investigation reports
- Design development and qualification studies
- Identify root cause and execute corrective and preventive actions
- Implement method lifecycle and method maintenance programs
- Lead CAPA and deviation and investigation tasks
- Lead continuous improvement efforts
- Maintain stewardship of molecular biology methods
- Optimize analytical methods
- Perform method execution training and instrument operation standardization
- Provide molecular biology analytical expertise for QC lab investigations
- Remediate analytical methods
- Respond to health authority questions
- Select and characterize reagents
- Support method validation and method transfer during inspections
- Train and mentor on molecular biology techniques
- Transfer commercial molecular biology methods
- Validate analytical methods
Perks/Benefits
Skills/Tech-stack
AAV | Analytical Method Maintenance | Analytical method validation | CAPA | CGMP | Deviation Management | EMA guidelines | EP Guidelines | FDA Guidelines | Gene delivery | ICH Guidelines | Investigation management | Lentiviral | Lifecycle Management | Method Lifecycle Management | Method transfer | Method validation | Molecular Biology | QC Laboratory | Regulatory writing | SOP Development | Technical documentation | Technical writing | Trend analysis | USP Guidelines | Vector analysis | Viral Vector | Viral vector analysis
Education
Bachelor of Engineering | Bachelor of Science | Master of Science
Roles
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