• Leading the analytical and clinical validation of IHC-based CDx assays in alignment with regulatory guidelines (e.g., FDA, EMA).
• Developing and optimizing IHC staining protocols to ensure robust, reproducible, and clinically meaningful biomarker detection.
• Performing histopathological assessment of tissue samples to evaluate assay performance, including scoring algorithm development and inter-observer variability studies.
• Collaborating closely with cross-functional teams (R&D, regulatory affairs, clinical operations, and pharmaceutical partners) to align diagnostic strategy with therapeutic development programs.
• Authoring technical documentation for regulatory submissions (e.g., NMPA) and supporting audits/inspections.
• Staying current with evolving biomarker science, regulatory landscapes, and clinical trial requirements for precision oncology.

Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

For more information, visit www.danaher.com.