Senior Scientist, NGS Design Transfer & Product Development

Natera, Inc.; San Carlos, Northern (CA, KY); Hybrid; USD 137,000 - 171,000; Full time

Benefits offered by this job

Annual incentive bonus

Equity awards

401(k) matching

Generous PTO

Job summary

Natera, Inc. is seeking a Senior Scientist, R&D Design Transfer & Product Development in California to lead and support the transition of IVD NGS assays from R&D to Operations.

You will plan, execute, and document design transfer activities while ensuring regulatory and quality compliance, balancing lab work, data analysis, and documentation. The role requires strong collaboration across functions to drive deliverables in a fast-paced environment, with responsibilities spanning IQ/OQ/PQ, TMV,

Qualifications

• PhD or Master’s/Bachelor’s with extensive industry experience in IVD/NGS
• Hands‑on NGS workflows and validated methods
• Experience authoring plans, protocols and reports (study/documents)
• Experience with GLP/GMP environments and regulatory standards (FDA, ISO 13485) preferred

Responsibilities

• Design Transfer & Validation: plan and execute IQ/OQ/PQ, stability studies, study protocols; analyze data and write final reports
• Test Method Development: support development, characterization, TMV, and manufacturing specifications
• Quality & Risk Management: lead risk management (FMEAs), maintain DHF and DMR
• Sustaining & Change Control: lead change control, assess impact on on‑market products
• CAPA & Troubleshooting: investigate deviations, perform root-cause analysis, implement CAPA
• Cross‑Functional Collaboration: partner with Supply Chain to ensure material pipelines and present data to stakeholders

Skills

NGS workflows

DNA/RNA extraction

PCR/qPCR/multiplex PCR

Data analysis

Documentation

Cross-functional collaboration

Statistical software (JMP)

Automated liquid handling (Hamilton/Ta

Education

PhD in Molecular Biology/Cell Biology/Biotechnology/Biochemistry

Master’s degree in related fields

Bachelor’s degree in related fields

Tools

JMP

Hamilton

Tecan

Job description

Natera, Inc. is seeking a Senior Scientist, R&D Design Transfer & Product Development in California to lead and support the transition of IVD NGS assays from R&D to Operations.

You will plan, execute, and document design transfer activities while ensuring regulatory and quality compliance, balancing lab work, data analysis, and documentation. The role requires strong collaboration across functions to drive deliverables in a fast-paced environment, with responsibilities spanning IQ/OQ/PQ, TMV,