Scientist, R&D Design Transfer & Product Development

Natera • Austin, TX

2d • Onsite

About The Position

The Scientist will lead and support the transition of In Vitro Diagnostic (IVD) Next-Generation Sequencing (NGS) assays from R&D to Operations. This role is responsible for planning, executing, and documenting all design transfer activities while ensuring strict compliance with regulatory and quality standards. The ideal candidate will balance hands-on laboratory work, data analysis, and documentation. As a cross-functional collaborator, you will interface with multiple functional groups to drive project deliverables to completion in a dynamic, fast-paced environment.

Requirements

• Ph.D. in Molecular Biology, Cell Biology, Biotechnology, Biochemistry, or a related scientific field with 2+ years of relevant industry experience; OR Master’s degree in the fields above with 5+ years of relevant industry experience; OR Bachelor’s degree in the fields above with 8+ years of relevant industry experience
• hands-on expertise in Next-Generation Sequencing (NGS) workflows such as DNA/RNA extraction, targeted enrichment, or whole genome library preparation and/or deep expertise with other DNA molecular biology techniques such as PCR, qPCR and multiplex PCR
• Ability to own a study from start to finish including designing experiments, executing in the lab, analyzing data and documenting results.
• Must be able to perform basic statistical analysis.
• Excellent cross-functional communication and interpersonal skills, with a proven ability to present complex technical data clearly to non-technical audiences
• Exceptional time management and organizational skills, with a demonstrated ability to balance multiple priorities and drive deliverables to completion

Nice To Haves

• Knowledge of Design Controls, Quality Management Systems (QMS), and regulatory standards (FDA, ISO 13485, CLSI) within GLP/GMP environments is highly desired
• Experience authoring study plans, protocols and study reports is highly desired
• Experience with statistical software (such as JMP) is highly desired
• Prior experience in IVD product development or commercialization is preferred
• Experience in manufacturing, scale up, and Quality Control (QC) is preferred
• Experience with automated liquid handling platforms (e.g., Hamilton, Tecan) is preferred

Responsibilities

• Plan and execute process validations (IQ/OQ/PQ), stability studies, and study protocols; perform data analysis and author final reports
• Support test method development, characterization, and Test Method Validation (TMV), including the generation of manufacturing specifications
• Lead Risk Management activities (including FMEAs) to identify and mitigate product risks; establish and maintain Design History Files (DHF) and Device Master Records (DMR)
• Lead change control activities to evaluate and determine the impact of design changes to on-market products
• Investigate product or process deviations, perform root cause analysis, and implement Corrective and Preventive Actions (CAPA)
• Partner with Supply Chain to establish raw material and consumable pipelines; present status updates, data, and technical proposals to cross-functional stakeholders

Benefits

• comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents
• free testing in addition to fertility care benefits
• pregnancy and baby bonding leave
• 401k benefits
• commuter benefits
• employee referral program

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree