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 RD 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: 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 RD 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 RR, 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, RD, 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; 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 KNOWLEDGE, SKILLS, AND ABILITIES: Must have hands-on experience with next-generation sequen ... (truncated, view full listing at source)