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 manager will oversee a multidisciplinary group of scientists, provide technical mentorship, ensure timely delivery of project milestones, establish robust processes and documentation, maintain compliance with regulatory requirements, and facilitate cross‑functional alignment.

• Plan and manage activities and studies from late‑stage development to launch
• Contribute to design documents including reagent stability plans, design inputs, outputs, and verification protocols while collaborating closely with Quality and Regulatory partners
• Participate in risk management activities such as hazard analysis and FMEA to identify hazards and propose mitigation controls
• Work with bioinformatics and statistics groups to align 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
• Ensure experimental quality through sound design, utilizing 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, proposing and implementing improvements
• Ensure compliance with FDA, ISO 13485, and quality system regulations during design transfer and production
• Communicate progress directly with colleagues and senior management

• Manage a team of scientists to coordinate studies that support development of QC methods, verification studies, and assay validation
• Provide leadership to ensure group effectiveness and career development
• Offer 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 core project and program meetings, providing 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 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 of experience managing a team of scientists and research associates

• 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…