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 in molecular biology or related discipline. PhD is preferred, Master’s or Bachelors 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 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
• 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