Scientist, R&D Design Transfer & Product Development Austin, TX

Scientist, R&D Design Transfer & Product Development

Austin, TX

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 design transfer activities while ensuring compliance with regulatory and quality standards. The ideal candidate balances 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.

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

• Ph.D. in Molecular Biology, Cell Biology, Biotechnology, Biochemistry, or related field with 2+ years of relevant industry experience.
• Master’s degree in the fields above with 5+ years of relevant industry experience.
• Bachelor’s degree in the fields above with 8+ years of relevant industry experience.

• Molecular Biology
  
  Experience:
  
  Hands‑on expertise in 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.
• Experimental & Analytical
  
  Skills:
  
  Ability to own a study from start to finish including designing experiments, executing in the lab, analyzing data and documenting results; must perform basic statistical analysis.
• Communication: Excellent cross‑functional communication and interpersonal skills, with a proven ability to present complex technical data clearly to non‑technical audiences.
• Execution: Exceptional time management and organizational skills, with a demonstrated ability to balance multiple priorities and drive deliverables to completion.
• 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.

$103,700 – $129,600 USD

Competitive benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. Employees and families receive free testing and fertility care benefits. Additional benefits include pregnancy and baby bonding leave, 401(k) benefits, commuter benefits and more.

Natera is a proud Equal Opportunity Employer and is committed to a diverse and inclusive workplace. All qualified applicants will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws.