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Jobs(38,923)/Product Designer Role(694)/Natera (70) - Scientist, R&D Design Transfer & Product Development
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Natera

Natera - Scientist, R&D Design Transfer & Product Development

Austin, TX2d ago
In OfficeMidNABiotechnologyGenomicsProduct DesignerProduct MarketingReportingRisk ManagementData AnalysisCross-functional CollaborationQuality ControlLiquid

Requirements

• Ph.D. in Molecular Biology, Cell Biology, Biotechnology, Biochemistry, or a related scientific field with 2+ years of relevant industry experience; OR • Ph.D. • 2+ years • Master’s degree in the fields above with 5+ years of relevant industry experience; OR • Master’s degree • 5+ years • Bachelor’s degree in the fields above with 8+ years of relevant industry experience • Bachelor’s degree • 8+ years • Molecular Biology 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 • 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 be able to 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 • Communication • Execution: Exceptional time management and organizational skills, with a demonstrated ability to balance multiple priorities and drive deliverables to completion • Execution • 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 • The pay range is listed and actual compensation packages are based on a wide array of factors unique to each candidate, including but not limited to skill set, years & depth of experience, certifications and specific office location. This may differ in other locations due to cost of labor considerations. • $103,700 - $129,600 USD • OUR OPPORTUNITY • OUR OPPORTUNITY • 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.

Responsibilities

• Design Transfer & Validation: Plan and execute process validations (IQ/OQ/PQ), stability studies, and study protocols; perform data analysis and author final reports • Design Transfer & Validation: • Test Method Development: Support test method development, characterization, and Test Method Validation (TMV), including the generation of manufacturing specifications • Test Method Development: • 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) • Quality & Risk Management: • Sustaining & Change Control: Lead change control activities to evaluate and determine the impact of design changes to on-market products • Sustaining & Change Control: • CAPA & Troubleshooting: Investigate product or process deviations, perform root cause analysis, and implement Corrective and Preventive Actions (CAPA) • CAPA & Troubleshooting: • 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 • Cross-Functional Collaboration:

Benefits

• 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! • For more information, visit www.natera.com.

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