Design Transfer Manager

Natera-posted about 2 months ago
Full-time • Manager
Austin, TX
1,001-5,000 employees
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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.

  • 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
  • Advanced degree in molecular biology or related discipline. PhD is preferred; Master’s or bachelor's 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
  • 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
  • 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
  • Knowledge of methylation-based technologies and their IVD application is highly desirable
  • Experience authoring study plans, protocols, and study reports is highly desirable
  • Experience with process validations for single-site oncology assays
  • 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!
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