Natera · 1 day ago
Design Transfer Manager
San Carlos, CA
Full-time
Onsite
Senior Level
$137K/yr - $171K/yr
6+ years expNatera is a global leader in cell-free DNA testing, specializing in oncology, women’s health, and organ health. They are seeking an experienced Design Transfer Manager to lead the transfer of an early cancer detection assay from R&D into Operations, ensuring compliance with regulatory requirements and managing a team of scientists.
BiotechnologyGeneticsHealth DiagnosticsMedicalWomen's
Responsibilities
Responsible for planning and managing activities and studies from late-stage development to launch
Contribute to design documents, such as reagent stability plans, design inputs, design outputs, design verification protocols and reports while working closely with Quality and Regulatory partners
Routinely participate in risk management activities (such as hazard analysis, FMEA) to identify hazards and its causes and propose controls to mitigate risks
Works closely with bioinformatics / statistics groups in aligning with rationale for study designs and acceptance criteria
Develop and execute detailed design transfer plans
Lead and coordinate design transfer activities from R&D to manufacturing
Lead test method development, characterization, and validation
Conduct studies to generate specifications and set process/test method specifications based on statistical analysis
Lead process validations; experience with single-site oncology assay validations is required
Assure experimental quality through sound experimental design; utilize DOE, Cpk analysis, and Gage R&R, and mentor others in study design
Lead cross-functional efforts to establish supply chain for raw materials and consumables; propose and implement improvements
Ensure compliance with FDA, ISO 13485, and quality system regulations during design transfer and production
Communicates progress directly with colleagues and senior management
Manages a team of scientists to coordinate the execution of studies to support development of QC methods, verification studies and validation of assays
Manage and provide leadership for scientists to ensure group effectiveness and development
Provide technical mentorship and decision-making support for the team
Monitor performance, deliver timely feedback, and support career development of direct reports
Foster a culture of accountability, safety, compliance, and continuous learning
Partner with Operations, R&D, Product Management, Quality Assurance, and Regulatory Affairs to ensure seamless design transfer and product launch
Serve as the primary liaison between development and operations, ensuring knowledge transfer and training of operational staff
Incorporate operational feedback into design improvements and refinements
Contribute technical and process documentation to regulatory submissions
Actively participate in the project core team and program team meetings, provide project updates to cross functional teams and senior leadership
Oversee creation, review, and approval of SOPs, work instructions, and verification/validation protocols and reports
Ensure compliance with FDA, ISO, CLSI, and other international regulatory requirements, including GLP/GMP
Maintain audit-ready documentation for internal and external inspections
Qualification
Required
Advanced degree in molecular biology or related discipline
6-8 years of post-PhD biotech industry experience or >10 years of post BS/MS biotech experience
At least 4 years managing a team of scientists and research associates
Must have hands-on experience with next-generation sequencing (NGS) and DNA/RNA molecular biology
Proven track record of successful design transfer for assays and medical devices
Strong understanding of assay development, design control, analytical validation, and manufacturing workflows
Extensive knowledge of quality and regulatory standards (ISO, CLSI, FDA)
Ability to establish and follow SOPs, with in-depth knowledge of GLP/GMP guidelines
Experience with process validations for single-site oncology assays
Proficiency in experimental design, statistical data analysis, and technical problem-solving
Demonstrated ability to lead multidisciplinary teams and provide mentorship to research associates and junior scientists
Strong project management and organizational skills
Excellent communication and presentation abilities, including reporting to senior leadership
Collaborative, adaptable, and focused on achieving business and corporate objectives
Preferred
PhD is preferred; Master's or bachelor's with equivalent industry experience considered
Knowledge of methylation-based technologies and their IVD application is highly desirable
Experience authoring study plans, protocols, and study reports is highly desirable
Benefits
Annual performance incentive bonus
Long-term equity awards
Comprehensive health benefits (medical, dental, vision)
401(k) with company match
Generous paid time off and company holidays
Additional wellness and work-life benefits
Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents.
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!
Company
Natera
Natera specializes in cell-free DNA testing to provide a more targeted interventions to oncology, women's health, and organ health.
5001-10000 employees
H1B Sponsorship
Natera has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (90)
2024 (72)
2023 (37)
2022 (71)
2021 (64)
2020 (40)
Funding
Current Stage
Public CompanyTotal Funding
$1.16BKey Investors
Sofinnova InvestmentsLightspeed Venture PartnersSequoia Capital
2023-09-07Post Ipo Equity· $250M
2022-11-15Post Ipo Equity· $400.05M
2022-03-16Post Ipo Equity· $5M
Leadership Team
Steve Chapman
CEO
Jonathan Sheena
Co-Founder, Board Member
Recent News
2026-01-08
Company data provided by crunchbase