Senior Scientist, Vector Analytical Science And Technology (ASAT), Cell Therapy
Tasks
- Author and revise test methods and SOPs
- Design development and qualification studies
- Identify root cause and implement CAPA
- Implement method lifecycle and maintenance
- Lead project and deviation investigations
- Optimize analytical methods
- Provide viral vector analytical expertise
- Respond to health authority questions
- Serve as method validation and transfer expert
- Steward viral vector analytical methods
- Support QC lab investigations
- Support regulatory submission analytical sections
- Train and mentor others
- Transfer commercial analytical methods
- Validate analytical methods in cGMP
Perks/Benefits
- 401k plan
- Employee assistance program
- Global shutdown
- Health coverage
- Life insurance
- Long-term disability
- Paid time off
- Short-term disability
Skills/Tech-stack
Analytical method validation | CAPA | CGMP | Cause analysis | Deviation investigations | European Pharmacopoeia | FDA Regulations | ICH Guidelines | Instrument operation | Lifecycle Management | Method Lifecycle Management | Method transfer | Method validation | Quality Control | Regulatory Compliance | Root Cause Analysis | Root cause | SOP Development | Technical writing | Trend reporting | USP standards | Vector analysis | Viral Vector | Viral vector analysis
Education
Roles
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