Natera is seeking to develop and launch high-quality clinical assays for patients, specifically in the field of oncology, by designing development, verification, and validation studies and ensuring the integration of automated workflows with digital systems.
Requirements
- Extensive hands-on experience with various molecular biology techniques including but not limited to: NGS, PCR/qPCR, and nucleic acid extraction and quantification
- Experience with the development of automated workflows is highly desired
- LDT product development and validation experience is highly desired
- Proficient in data analysis using tools such as Excel or JMP
- Experience with reagent QC development is a plus
- Must be able to independently design and execute experiments, interpret results, and decide on next steps
- Must have experience with next generation sequencing (NGS) assay development and validation
Responsibilities
- Design development, verification, and validation studies with stakeholder input and coordinate efforts to achieve milestones within established timelines
- Collaborate closely with cross-functional teams, such as automation, engineering, R&D, bioinformatics, and lab operations, to develop robust, automated workflows
- Lead the integration of automated workflows with digital systems such as LIMS and LabVantage (LV). Support the design and execution of integration testing to ensure data integrity between automation and digital systems
- Plan and execute moderate to high complexity experiments
- Identify the root cause of problems and develop solutions to resolve problems effectively
- Perform basic data analysis (e.g. Excel, JMP). Coordinate the analysis of studies with biostatistics and bioinformatics teams
- Author and review SOPs, study reports, and transfer documents for production implementation
Other
- Ph.D with 5 years of industry experience OR Master's degree with 7 years of industry experience required
- Ability to manage multiple priorities in a fast-paced, dynamic environment
- Exceptional communication and presentation skills with meticulous attention to detail
- A proactive, solutions-oriented mindset and demonstrated success in collaborative and individual projects
- Demonstrated ability to write clear project plans, study protocols and reports, and SOPs
