Senior Manager, Development and Design Transfer

Natera • Austin, TX

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About The Position

Natera is seeking an experienced Senior Manager, Design Transfer to lead the transfer of products from R&D into Operations. The role plans, executes, implements, and documents design transfer activities for a next-generation sequencing (NGS) IVD/PMA assay under Quality Systems Regulations and Design Control. It manages a multidisciplinary group of scientists, provides technical mentorship, and ensures timely project milestones, robust processes and documentation, regulatory compliance, and cross-functional alignment.

The Senior Manager leads design transfer from late-stage development through launch, including test method development, characterization and validation, process validation, and the establishment of specifications using statistical analysis. The role works closely with Quality, Regulatory, bioinformatics, statistics, Operations, and other partners to coordinate studies, transfer knowledge to operational staff, establish supply chains, and support product launch. It also oversees documentation and compliance with applicable quality systems and regulatory requirements.

The role requires an advanced degree in molecular biology or a related discipline; a PhD is preferred, while a Master’s or Bachelor’s degree with equivalent industry experience may be considered. The listed experience requirements are 6–8 years of post-PhD biotech industry experience or more than 10 years of post-BS/MS biotech experience, plus at least four years managing scientists and research associates. Hands-on NGS and DNA/RNA molecular biology experience and a record of successful assay or medical-device design transfer are required. The position is based in Austin, Texas. The listed salary range is $143,100–$178,900 USD; compensation may vary based on candidate-specific factors and office location.

Requirements

• Advanced degree in molecular biology or a related discipline; a PhD is preferred, and a Master’s or Bachelor’s degree with equivalent industry experience may be considered.
• 6–8 years of post-PhD biotech industry experience or more than 10 years of post-BS/MS biotech experience.
• At least four years managing a team of scientists and research associates.
• 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, including ISO, CLSI, and FDA requirements.
• 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 mentor 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 business and corporate objectives.

Nice To Haves

• PhD in molecular biology or a related discipline.
• Experience authoring study plans, protocols, and study reports.

Responsibilities

• Plan and manage activities and studies from late-stage development through launch.
• Develop and execute detailed design transfer plans and coordinate transfer activities from R&D to manufacturing.
• Contribute to design documents, including reagent stability plans, design inputs and outputs, and design verification protocols and reports, in collaboration with Quality and Regulatory partners.
• Participate in risk management activities such as hazard analysis and FMEA, identifying hazards and proposing controls to mitigate risk.
• Work with bioinformatics and statistics groups to align study-design rationale and acceptance criteria.
• Lead test method development, characterization, and validation.
• Conduct studies to generate specifications and establish process and test-method specifications using statistical analysis.
• Lead process validations, including single-site oncology assay validations.
• Ensure experimental quality through sound study design; use DOE, Cpk analysis, and Gage R&R, and mentor others in study design.
• Lead cross-functional work to establish supply chains for raw materials and consumables and implement improvements.
• Ensure compliance with FDA, ISO 13485, and quality system regulations during design transfer and production.
• Manage and develop a team of scientists coordinating studies for QC methods, verification studies, and assay validation.
• Provide technical mentorship and decision-making support; monitor performance, give timely feedback, and support direct reports’ career development.
• Foster accountability, safety, compliance, and continuous learning.
• Participate in project core-team and program-team meetings and provide updates to cross-functional teams and senior leadership.
• Partner with Operations, R&D, Product Management, Quality Assurance, and Regulatory Affairs to support design transfer and product launch.
• Serve as the primary liaison between development and operations, ensuring knowledge transfer and operational staff training.
• Incorporate operational feedback into design improvements and refinements.
• Contribute technical and process documentation to regulatory submissions.
• Oversee the creation, review, and approval of SOPs, work instructions, and verification and validation protocols and reports.
• Maintain audit-ready documentation for internal and external inspections and ensure compliance with FDA, ISO, CLSI, GLP/GMP, and other applicable international requirements.

Benefits

• Comprehensive medical, dental, vision, life, and disability plans for eligible employees and their dependents.
• Free testing for employees and their immediate families.
• Fertility care benefits.
• Pregnancy and baby bonding leave.
• 401(k) benefits.
• Commuter benefits.
• Employee referral program.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior