Senior Manager, Development and Design Transfer New Austin, TX

Natera, Inc.; Austin (TX); On-site; USD 143,000 - 179,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

Life insurance

Disability plans

Free genetic testing

Fertility care

401k

Commuter benefits

Employee referral program

Job summary

Natera, Inc. in Austin, TX seeks a Senior Manager of Development and Design Transfer to lead the transfer of NGS-based assays from R&D into Operations.

You will plan, execute, document, and validate design transfer activities under Quality Systems Regulations and Design Control, coordinating with cross-functional teams to meet milestones. The role requires mentoring a multidisciplinary science group, building robust processes, and ensuring regulatory compliance.

Qualifications

• Advanced degree in molecular biology or related discipline. PhD 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

Responsibilities

• Plan and manage activities and studies from late-stage development to launch
• Lead design transfer plans and coordinate transfer from R&D to manufacturing
• Lead test method development, characterization, and validation
• Ensure compliance with FDA, ISO 13485 and QSR during design transfer and production
• Communicate progress to senior management and cross-functional teams
• Mentor and develop scientists and ensure group effectiveness

Skills

NGS knowledge

Design transfer

Regulatory compliance

Leadership

DOE analysis

Statistical analysis

Project management

Education

PhD in molecular biology

Masters or Bachelors with equivalent experience

Job description

Senior Manager, Development and Design Transfer

Austin, TX

POSITION SUMMARY:

We are seeking an experienced Senior Manager, Design Transfer to lead and coordinate the transfer of products 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:

• 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
• Actively participate in the project core team and program team meetings, provide project updates to cross functional teams and senior leadership

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
• 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

The pay range is listed and actual compensation packages are based on a wide array of factors unique to each candidate, including but not limited to skill set, years & depth of experience, certifications and specific office location. This may differ in other locations due to cost of labor considerations.

Austin, TX

$143,100 - $178,900 USD

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.

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.