Design Transfer Scientist
Position Summary
Join Natera's Bio Development Team as a Design Transfer Scientist to lead the transition of our market-leading In Vitro Diagnostic (IVD) Next-Generation Sequencing (NGS) assays from R&D into scalable clinical operations. This role bridges molecular biology with manufacturing execution, requiring an ownership mindset to build robust, compliant production pipelines that directly impact patient care.
Primary Responsibilities
Own and execute process validations, stability studies, and study protocols, translating raw experimental data into final technical reports
Support test method development, characterization, and Test Method Validation (TMV) to generate accurate manufacturing specifications
Lead risk management activities, including FMEAs, to identify and mitigate potential product risks early
Manage change control workflows to evaluate and document the operational impact of design changes on on-market products
Investigate product or process deviations, perform rigorous root cause analysis, and implement sustainable Corrective and Preventive Actions (CAPA)
Coordinate with multiple internal groups (automation engineering, laboratory operations, bioinformatics, statistics, project and product management) and serve as point person to ensure the successful identification and timely execution of projects
Partner directly with Supply Chain to establish reliable raw material and consumable pipelines
Communicate complex technical updates, data-driven proposals, and project status clearly to cross-functional stakeholders across the business
Qualifications
BA/BS with 8+ years experience, MS with 5+ years or PhD with 3+ years experience in assay development and automation for the life science industry
Experience with automated high-throughput NGS assays
Knowledge, Skills, and Abilities
Hands-on expertise with Next-Generation Sequencing (NGS) workflows, including DNA/RNA extraction, targeted enrichment, or library preparation
Direct experience executing molecular biology techniques such as nucleic acid extraction, PCR, NGS library preparation, and hybrid capture technologies
Strong operational knowledge of Design Controls, Quality Management Systems (QMS), and regulatory standards (FDA, ISO 13485, CLSI) within regulated clinical diagnostic manufacturing environments
Proven track record authoring comprehensive study plans, validation protocols, and technical reports
Proficiency in statistical analysis with experience using specialized software such as Minitab or JMP
Prior experience in IVD product development, scale-up, manufacturing, or commercial Quality Control (QC) is highly preferred
Experience operating or optimizing automated liquid handling platforms (such as Hamilton or Tecan) is preferred
Exceptional organization skills to manage complex validation timelines and drive technical projects to successful completion
Career Opportunities
Natera™ is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthier lives.
The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other. When you join Natera, you’ll work hard and grow quickly. Working alongside the elite of the industry, you’ll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management.
What We Offer
Competitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. Additionally, Natera employees and their immediate families receive free testing in addition to fertility care benefits. Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more. We also offer a generous employee referral program!
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Contact Information
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Link: https://www.natera.com/notice-of-data-collection-california-residents/
Please be advised that Natera will reach out to candidates with a @natera.com email domain ONLY. Email communications from all other domain names are not from Natera or its employees and are fraudulent. Natera does not request interviews via text messages and does not ask for personal information until a candidate has engaged with the company and has spoken to a recruiter and the hiring team. Natera takes cyber crimes seriously, and will collaborate with law enforcement authorities to prosecute any related cyber crimes.
For more information:
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