Design Transfer Manager

POSITION SUMMARY:

We are seeking an experienced Design Transfer Manager to lead and coordinate the transfer of an early cancer detection assay from R&D into Operations. This role will plan execute implement and document all design transfer activities for a next generation sequencing (NGS) IVD/PMA assay under Quality Systems Regulations and Design Control. The role will be managing a multidisciplinary group of scientists providing technical mentorship and ensuring timely delivery of project milestones. The manager also will ensure robust processes documentation compliance with regulatory requirements and cross-functional alignment.

PRIMARY RESPONSIBILITIES:

Design Transfer Leadership

• 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

Team & People 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

Cross-Functional Collaboration

• 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

Documentation & Compliance

• 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

QUALIFICATIONS:

• Advanced degree in molecular biology or related discipline. PhD is preferred; Masters or bachelors with equivalent industry experience considered
• 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

KNOWLEDGE SKILLS AND ABILITIES:

• Must have hands-on experience with next-generation sequencing (NGS) and DNA/RNA molecular biology
• Knowledge of methylation-based technologies and their IVD application is highly desirable
• 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 authoring study plans protocols and study reports is highly desirable
• 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

OUR OPPORTUNITY

Natera is a global leader in cell-free DNA (cfDNA) testing dedicated to oncology womens 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 youll work hard and grow quickly. Working alongside the elite of the industry youll 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!

For more information visit .

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.

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