Contract Design Control Scientist New South San Francisco

Natera, Inc.; South San Francisco (CA); Ibrido; USD 110.000 - 170.000; Tempo pieno

Descrizione del lavoro

Natera is a global leader in cfDNA testing, dedicated to oncology, women's health, and organ health. The Contract Design Control Scientist role in South San Francisco blends R&D science with regulatory compliance to produce audit-ready design-controlled documents across the product lifecycle.

Within the Platform department, you translate laboratory data and software workflows into traceable deliverables, drive change-control and collaborate with Engineering, Data Science, RA/QA to support a

Competenze

• BS or higher in a scientific discipline (molecular biology, biochemistry, genomics, or related field) or equivalent industry experience.
• 5+ years of experience producing controlled documentation in the medical device, IVD, or life science industry.
• Knowledge of FDA QMSR, 21 CFR Part 11, GCP, CAP/CLIA, HIPAA, IVDR, and/or GDPR.
• Experience interpreting JSON/XML for documentation purposes.
• Track record of cross-functional collaboration with Engineering, Product Management, Data Science, Biostatistics, Science, and RA/QA.

Mansioni

• Author and maintain design controlled documentation in compliance with FDA QMSR, 21 CFR Part 11, GCP, CAP/CLIA, HIPAA, IVDR, and GDPR.
• Translate laboratory processes, study plans, and analytical data into traceable, compliant deliverables.
• Establish and maintain traceability across project documentation, linking requirements to design outputs and verification evidence.
• Review development reports, team resources, and software scripts to extract and synthesize information for controlled documents.
• Create onboarding and training documentation for R&D and CLIA team members, including training plans and departmental practice descriptions.
• Manage documentation filing, version control, and change-control workflows within quality management systems.
• Identify opportunities to improve documentation processes, templates, and deliverable quality.
• Perform other duties as assigned.

Conoscenze

Scientific literacy

Written communication

Attention to detail

Cross-functional collaboration

Self-directed work

Formazione

Bachelor's degree in a scientific discipline

Strumenti

MasterControl

Confluence

JSON

XML

Descrizione del lavoro

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&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&D scientists to clinical professionals.

Primary Responsibilities

• Author and maintain design controlled documentation in compliance with FDA QMSR, 21 CFR Part 11, GCP, CAP/CLIA, HIPAA, IVDR, and GDPR.
• Translate laboratory processes, study plans, and analytical data into traceable, compliant deliverables (e.g., development reports, verification/validation protocols, specifications).
• Establish and maintain traceability across project documentation, linking requirements to design outputs and verification evidence.
• Review development reports, team resources, and software scripts to extract and synthesize information for controlled documents.
• Create onboarding and training documentation for R&D and CLIA team members, including training plans and departmental practice descriptions.
• Manage documentation filing, version control, and change-control workflows within quality management systems.
• Identify opportunities to improve documentation processes, templates, and deliverable quality.
• Perform other duties as assigned.

Qualifications

• BS or higher in a scientific discipline (molecular biology, biochemistry, genomics, or related field) or equivalent industry experience.
• 5+ years of experience producing controlled documentation in the medical device, IVD, or life science industry.
• Demonstrated experience working in a regulated environment with knowledge of FDA QMSR, 21 CFR Part 11, GCP, CAP/CLIA, HIPAA, IVDR, and/or GDPR.
• Experience interpreting software implementations and structured data formats (JSON, XML) for documentation purposes.
• Track record of working cross-functionally with Engineering, Product Management, Data Science, Biostatistics, Science, and RA/QA teams.

Knowledge, Skills, and Abilities

• Strong scientific literacy with the ability to rapidly learn and document complex molecular biology and bioinformatics workflows.
• Excellent written communication; clear, concise, and precise in producing regulated documentation.
• Strong attention to detail, particularly around traceability and regulatory language.
• Proficiency with quality management systems and document-control platforms (e.g., MasterControl) and collaboration tools (e.g., Confluence).
• Working knowledge of the product-development lifecycle and change-control management processes.
• Self-directed with the ability to manage multiple documentation deliverables independently.
• Preferred domain knowledge: LIMS, LIS, LES, and/or ELN; genomics data-analysis pipelines; laboratory instrumentation and software-compliance requirements.

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.

WHAT WE OFFER

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!

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.

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.

If you are based in California, we encourage you to read this important information for California residents.

Please be advised that Natera will reach out to candidates with a @ natera.com 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.

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file.

As set forth in Natera's Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.