Design Transfer Manager
NateraAustin, TX, US3 days ago
Job type
- Full-time
Job descriptionManages 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 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 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 > 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 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
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.
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
Cross-Functional Collaboration
Documentation & Compliance
Qualifications :
10 years of post BS / MS biotech experience
Knowledge, Skills, and Abilities :
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Manager Transfer • Austin, TX, US