Senior Manager, Development and Design Transfer

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: 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 • 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 i