Staff Scientist, Molecular Diagnostics R&D-Lead Product Dev

CareDx, Inc.; California, Northern (MO, KY); Hybrid; USD 161,000 - 201,000; Full time

Benefits offered by this job

Health benefits

Gym reimbursement

30 days paid donor leave

Job summary

CareDx, Inc. in Brisbane, CA seeks a Staff Scientist, Molecular Diagnostics R&D to lead sustaining, improvement and new product development for transplant diagnostic assays in a CLIA laboratory.

The role requires a PhD in a related field with 8+ years in molecular diagnostics, deep expertise in gene expression profiling, and hands-on experience with regulated assay development and data reporting.

Qualifications

• PhD in Molecular Biology, Immunology, Genomics, or related field and 8+ years in molecular diagnostic assay development.
• Deep expertise in gene expression profiling and low input genomics.
• Experience developing diagnostics in regulated environments (CLIA/CAP/FDA/ISO).
• Proven ability to lead cross-functional R&D programs and mentor staff.
• Strong communication, data analysis, and documentation skills.

Responsibilities

• Provide technical leadership for cross-functional programs translating product needs into requirements.
• Lead assay optimization and sustaining improvements for robust, scalable diagnostics.
• Drive new product development, experimental design, and analytical validation.
• Define plans to validate assay performance per CLSI guidelines.
• Manage and mentor junior scientists, ensuring high-quality data generation.
• Collaborate with Bioinformatics, Clinical, Regulatory, and Operations teams for tech transfer.

Skills

Molecular diagnostics

Gene expression profiling

Low input genomics

Regulated diagnostic development

Project leadership

Data analysis

Documentation

Education

PhD in Molecular Biology, Immunology, Genomics, or related field

Tools

NGS workflows

PCR/qPCR

Nucleic acid extraction

Job description

CareDx, Inc. in Brisbane, CA seeks a Staff Scientist, Molecular Diagnostics R&D to lead sustaining, improvement and new product development for transplant diagnostic assays in a CLIA laboratory.

The role requires a PhD in a related field with 8+ years in molecular diagnostics, deep expertise in gene expression profiling, and hands-on experience with regulated assay development and data reporting.