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Scientist, R&D Design Transfer & Product Development

Nat*** · Austin, TX, United States
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Austin, TX, United States103,700-129,600 USD/yearlyOnsite
Remuneration
103,700-129,600 USD/yearly
Location
Austin, TX, United States
Visa sponsorship
Sponsors visa

Job summary

POSITION SUMMARY: 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.

Benefits

CompetitiveEmployeeInclude comprehensive medical, dental, vision, life and disability plans for eliAdditionally, Natera employees and their immediate families receive free testingInclude pregnancy and baby bonding leave, 401kCommuterAnd much more.We also offer a generous employee referral program!For more information, visit www.natera.com.Natera is proud to be an Equal Opportunity Employer.Inclusive collaborationOur employees, our community and our patients, and is critical to our mission of

Qualifications

  • Experimental & Analytical

Responsibilities

  • This role is responsible for planning, executing, and documenting all design transfer activities while ensuring strict compliance with regulatory and quality standards.
  • 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) to 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 cross-functional stakeholders
  • EDUCATION & EXPERIENCE:
  • Ph.
  • 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

Skills

Communication

Degrees

AssociateBachelorDegreeMasterPhD

Industry

AutomotiveBiotechEducationLogisticsManufacturingMedia

Company size

Smb