Senior Scientist, R&D Design Transfer & Product Development
Natera
Natera seeks a Senior Design Transfer Scientist to lead the transition of NGS-based diagnostic assays from research to operations. The role requires planning and executing design validations, managing regulatory compliance, and collaborating across functions to support product commercialization.
Responsibilities
- Plan and execute process validations (IQ/OQ/PQ), stability studies, and generate final reports
- Support test method development and validation including manufacturing specification generation
- Lead risk management activities and maintain Design History Files and Device Master Records
- Evaluate design changes and impact assessments for commercialized products
- Investigate product deviations, perform root cause analysis, and implement corrective actions
Requirements
- PhD in molecular biology, biotechnology, or related field with 4+ years industry experience
- Master's degree in life sciences with 7+ years relevant industry experience (alternative)
- Bachelor's degree with 10+ years relevant industry experience (alternative)
- Hands-on NGS expertise including DNA/RNA extraction and library preparation techniques
- Proficiency in experimental design, lab execution, data analysis, and technical documentation
- Knowledge of design controls, QMS, FDA/ISO 13485 standards, and GMP environments
- Strong cross-functional communication and ability to present technical data to diverse audiences
Vacancy posted 6 days ago
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