Senior Manager, Development and Design Transfer

Natera • Austin, TX

2d • $143,100 - $178,900

About The Position

Natera is seeking an experienced Senior Manager, Development and Design Transfer to lead the transfer of next-generation sequencing (NGS) in vitro diagnostic (IVD)/PMA assays from R&D into Operations. The role plans, executes, implements, and documents design transfer activities under Quality Systems Regulations and Design Control, while managing and mentoring a multidisciplinary team of scientists and ensuring project milestones are delivered on time.

The Senior Manager develops and executes design transfer plans; contributes to design documents and study plans; leads test method development, characterization, validation, and process validations; and uses statistical and experimental-design methods to establish specifications and ensure experimental quality. The role partners across Operations, R&D, Product Management, Quality Assurance, Regulatory Affairs, bioinformatics, and statistics to support product launch, regulatory submissions, supply chain readiness, and operational training.

The position also oversees controlled documentation and maintains compliance with FDA, ISO, CLSI, GLP/GMP, and other applicable requirements. It provides technical leadership, performance feedback, and career-development support to direct reports, and communicates progress to cross-functional teams and senior leadership. The position is based in Austin, Texas. The listed pay range is $143,100–$178,900 USD; actual compensation depends on factors including qualifications, experience, and location.

Requirements

• Advanced degree in molecular biology or a related discipline; a master's or bachelor's degree with equivalent industry experience is also considered.
• Six to eight years of post-PhD biotech industry experience, or more than ten years of post-bachelor's/master's biotech experience.
• At least four years of experience 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 and adaptable approach 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 product launch.
• Develop and execute detailed design transfer plans and lead 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 partnership with Quality and Regulatory teams.
• Participate in risk management activities, including hazard analysis and FMEA, and propose controls to mitigate identified risks.
• Work with bioinformatics and statistics groups to align study-design rationale and acceptance criteria.
• Lead test method development, characterization, and validation.
• Conduct studies and use statistical analysis to generate specifications and establish process and test-method specifications.
• Lead process validations, including validations for single-site oncology assays.
• Ensure sound experimental design using methods such as DOE, Cpk analysis, and Gage R&R, and mentor others in study design.
• Lead cross-functional efforts to establish raw-material and consumables supply chains and implement improvements.
• Ensure compliance with FDA, ISO 13485, and quality system regulations during design transfer and production.
• Manage a team of scientists coordinating studies that support QC method development, verification studies, and assay validation.
• Provide team leadership, technical mentorship, decision-making support, timely performance feedback, and career-development support.
• 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 contribute technical and process documentation to regulatory submissions.
• Oversee creation, review, and approval of SOPs, work instructions, and verification and validation protocols and reports.
• Maintain audit-ready documentation for internal and external inspections.

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