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

Apply

Vacancy posted 27 days ago

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