Contract Design Control Scientist at Natera

<h3><span style="color: #000000;"><strong>Position Summary</strong></span></h3> <p><span style="color: #000000;">This is a full-time, contract hybrid position in South San Francisco, CA. The Contract Design Control Scientist supports the Platform department by owning and improving design controlled documentation across the product development lifecycle. This role bridges R&amp;D science and regulatory compliance; translating laboratory processes, study data, and software workflows into traceable, audit-ready deliverables. The ideal candidate combines a strong scientific foundation with the ability to navigate regulated environments, engage cross-functional stakeholders, and communicate complex technical concepts to audiences ranging from R&amp;D scientists to clinical professionals.</span></p> <p>&nbsp;</p> <h3><span style="color: #000000;"><strong>Primary Responsibilities</strong></span></h3> <ul> <li style="color: #000000 !important;"><span style="color: #000000;">Author and maintain design controlled documentation in compliance with FDA QMSR, 21 CFR Part 11, GCP, CAP/CLIA, HIPAA, IVDR, and GDPR.</span></li> <li style="color: #000000 !important;"><span style="color: #000000;">Translate laboratory processes, study plans, and analytical data into traceable, compliant deliverables (e.g., development reports, verification/validation protocols, specifications).</span></li> <li style="color: #000000 !important;"><span style="color: #000000;">Establish and maintain traceability across project documentation, linking requirements to design outputs and verification evidence.</span></li> <li style="color: #000000 !important;"><span style="color: #000000;">Review development reports, team resources, and software scripts to extract and synthesize information for controlled documents.</span></li> <li style="color: #000000 !important;"><span style="color: #000000;">Create onboarding and training documentation for R&amp;D and CLIA team members, including training plans and departmental practice descriptions.</span></li> <li style="color: #000000 !important;"><span style="color: #000000;">Manage documentation filing, version control, and change-control workflows within quality management systems.</span></li> <li style="color: #000000 !important;"><span style="color: #000000;">Identify opportunities to improve documentation processes, templates, and deliverable quality.</span></li> <li style="color: #000000 !important;"><span style="color: #000000;">Perform other duties as assigned.</span></li> </ul> <p>&nbsp;</p> <h3><span style="color: #000000;"><strong>Qualifications</strong></span></h3> <ul> <li style="color: #000000 !important;"><span style="color: #000000;">BS or higher in a scientific discipline (molecular biology, biochemistry, genomics, or related field) or equivalent industry experience.</span></li> <li style="color: #000000 !important;"><span style="color: #000000;">5+ years of experience producing controlled documentation in the medical device, IVD, or life science industry.</span></li> <li style="color: #000000 !important;"><span style="color: #000000;">Demonstrated experience working in a regulated environment with knowledge of FDA QMSR, 21 CFR Part 11, GCP, CAP/CLIA, HIPAA, IVDR, and/or GDPR.</span></li> <li style="color: #000000 !important;"><span style="color: #000000;">Experience interpreting software implementations and structured data formats (JSON, XML) for documentation purposes.</span></li> <li style="color: #000000 !important;"><span style="color: #000000;">Track record of working cross-functionally with Engineering, Product Management, Data Science, Biostatistics, Science, and RA/QA teams.</span></li> </ul> <p>&nbsp;</p> <h3><span style="color: #000000;"><strong>Knowledge, Skills, and Abilities</strong></span></h3> <ul> <li style="color: #000000 !important;"><span style="color: #000000;">Strong scientific literacy with the ability to rapidly learn and document complex molecular biology and bioinformatics workflows.</span></li> <li style="color: #000000 !important;"><span style="color: #000000;">Excellent written communication; clear, concise, and precise in producing regulated documentation.</span></li> <li style="color: #000000 !important;"><span style="color: #000000;">Strong attention to detail, particularly around traceability and regulatory language.</span></li> <li style="color: #000000 !important;"><span style="color: #000000;">Proficiency with quality management systems and document-control platforms (e.g., MasterControl) and collaboration tools (e.g., Confluence).</span></li> <li style="color: #000000 !important;"><span style="color: #000000;">Working knowledge of the product-development lifecycle and change-control management processes.</span></li> <li style="color: #000000 !important;"><span style="color: #000000;">Self-directed with the ability to manage multiple documentation deliverables independently.</span></li> <li style="color: #000000 !important;"><span style="color: #000000;">Preferred domain knowledge: LIMS, LIS, LES, and/or ELN; genomics data-analysis pipelines; laboratory instrumentation and software-compliance requirements.</span></li> </ul><div class="content-conclusion"><p><strong>OUR OPPORTUNITY</strong></p> <p>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.</p> <p>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.</p> <p><strong>WHAT WE OFFER</strong></p> <p>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!</p> <p>For more information, visit <a href="http://www.natera.com/" data-cke-saved-href="http://www.natera.com/">www.natera.com</a>.</p> <p>Natera is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives. Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide.</p> <p>All qualified applicants are encouraged to apply, and 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.</p> <p><em>If you are based in California, we encourage you to read this important information for California residents.&nbsp;</em></p> <p>Link: <a href="https://www.natera.com/notice-of-data-collection-california-residents" target="_blank">https://www.natera.com/notice-of-data-collection-california-residents/</a></p> <p>Please be advised that Natera will reach out to candidates with a @<a href="http://natera.com/" target="_blank" data-saferedirecturl="https://www.google.com/url?q=http://natera.com&amp;source=gmail&amp;ust=1657718972773000&amp;usg=AOvVaw3zRwaIiu7070kJKNG4hjRm">natera.com</a>&nbsp;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.</p> <p>For more information:<br>- <a href="https://www.bbb.org/article/tips/12261-bbb-tip-employment-scams" target="_blank">BBB announcement on job scams</a>&nbsp;<br>- <a href="https://www.fbi.gov/investigate/cyber" target="_blank">FBI Cyber Crime resource page</a>&nbsp;</p></div>