Scientist, Molecular Diagnostics R&D

CareDx is a leading precision medicine diagnostics company advancing care in transplant, specialty oncology, and cell therapy. Through our innovative portfolio of molecular diagnostics, digital health solutions, AI-powered data and analytics, and patient support services, we partner with healthcare providers, patients, and biopharma organizations to help inform clinical decision-making and improve patient outcomes.

At CareDx, every employee has the opportunity to contribute to innovations that help transform patient care and improve lives.

CareDx is seeking an experienced Staff Scientist, Molecular Diagnostics R&D to lead sustaining, improvement and product development efforts for our transplant diagnostic assays implemented in CareDx’s CLIA laboratory. This role will serve as a technical lead on cross-functional R&D programs to drive product improvements and innovative product development. The ideal candidate brings deep expertise in Diagnostic Product Development in gene expression profiling, low input genomics assays, and regulated diagnostic development, and thrives in a collaborative, fast-paced environment.

Responsibilities: 

· Provide technical leadership for cross-functional programs, translating product needs into technical requirements and performance criteria

· Lead assay optimization, troubleshooting, and sustaining improvements to ensure performance, robustness, and scalability of complex molecular diagnostic assays

· Drive new product development, including experimental design, development, and analytical validation

· Define and execute plans to validate assay performance in accordance with CLSI guidelines

· Manage and mentor junior scientific personnel while ensuring high-quality data generation, analysis, and reporting

· Partner cross-functionally (Bioinformatics, Clinical, Regulatory, Operations) to define development strategy and enable technology transfer

Minimum Education, Experience, & Specialized Knowledge (Required): 

· PhD in Molecular Biology, Immunology, Genomics, or related field, with 8+ years in molecular diagnostic assay development

· Deep expertise and hands on experience with gene expression profiling, nucleic acid extraction methods, low input nucleic acid assays, NGS workflows, and PCR/qPCR.

· Strong experience with assay development, optimization, and validation in regulated environments (CLIA/CAP/FDA/ISO)

· Proven ability to lead projects, solve complex technical problems, and collaborate across functions

· Demonstrated experience leading small teams, including setting priorities, guiding experimental design, mentoring team members and fostering a high performance and collaborative team culture.

· Excellent communication, data analysis, and documentation skills