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.
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
Additional Details:
Every individual at CareDx has a direct impact on our collective mission to improve the lives of organ transplant patients worldwide. We believe in taking great care of our people, so they take even greater care of our patients.
Our competitive Total Rewards package for US Employees includes:
- Competitive base salary and incentive compensation
- Health and welfare benefits, including a gym reimbursement program
- 401(k) savings plan match
- Employee Stock Purchase Plan
- Pre-tax commuter benefits
- And more!
- Please refer to our page to view detailed benefits at https://caredx.com/company/careers
In addition, we have a Living Donor Employee Recovery Policy that allows up to 30 days of paid leave annually to a full-time employee who makes the selfless act of donating an organ or bone marrow.
With products that are making a difference in the lives of transplant patients today and a promising pipeline for the future, it’s an exciting time to be part of the CareDx team. Join us in partnering with transplant patients to transform our future together.
CareDx, Inc. is an Equal Opportunity Employer-vets/disabled, and participates in the E-Verify program. By proceeding with our application and submitting your information, you acknowledge that you have read our U.S. Personnel Privacy Notice and consent to receive email communication from CareDx. Certain jurisdictions require notice of how we use and protect your personal information. For more information, please read our Privacy Policy
The U.S. EEO posters are available here.
Note: We do not accept resumes from headhunters, placement agencies, or other suppliers that have not signed a formal agreement with us.
This is the anticipated base salary range for candidates who will work in Brisbane, California. The final salary offered to a successful candidate will be dependent on several factors that may include, but are not limited to, the type and length of experience within the job, the type and length of experience within the industry, education, etc. Base pay is one part of the Total Package that is provided to compensate and recognize employees for their work, and this role may be eligible for additional discretionary bonuses/incentives and restricted stock units. CareDx is a multi-state employer, and this salary range may not reflect positions that work in other states.
Skills Required
- PhD in Molecular Biology, Immunology, Genomics, or a related field
- 8+ years of experience in molecular diagnostic assay development
- Hands-on expertise in gene expression profiling
- Experience with nucleic acid extraction methods
- Experience with low-input nucleic acid assays
- Experience with NGS workflows
- Experience with PCR/qPCR
- Experience developing, optimizing, and validating assays in regulated CLIA, CAP, FDA, or ISO environments
- Ability to lead projects and solve complex technical problems
- Cross-functional collaboration experience
- Experience leading small teams, setting priorities, guiding experimental design, and mentoring personnel
- Excellent communication, data analysis, and documentation skills
What We Do
CareDx: Transforming Transplant Patient Care Through Novel Surveillance Management Solutions CareDx, Inc. is dedicated to improving the lives of organ transplant patients through non-invasive diagnostics. By combining the latest advances in genomics and bioinformatics technology, with a commitment to generating high quality clinical evidence through trials and registries, CareDx is at the forefront of organ transplant surveillance and pre-transplant HLA typing solutions. NASDAQ:CDNA About AlloSure® AlloSure is the first and only non-invasive blood test that directly measures allograft injury and identifies the probability of active rejection to better manage kidney transplant patients. AlloSure is a clinical-grade, proprietary Next-Generation Sequencing (NGS) based test to detect donor-derived cell-free DNA (dd-cfDNA) in order to identify organ injury in kidney transplant recipients. AlloSure is analytically validated as a sensitive, specific, and precise measurement of dd-cfDNA. AlloSure detects active rejection (acute active ABMR, chronic active ABMR, or TCMR) with high accuracy, outperforms serum creatinine in kidney transplant recipients, and is highly sensitive in distinguishing ABMR from no ABMR. AlloSure is performed in the CareDx CLIA-certified laboratory. http://www.allosure.com/ About AlloMap® AlloMap Molecular Expression Testing is a non-invasive blood test used to aid in the identification of heart transplant recipients with stable allograft function who have a low probability of moderate/severe acute cellular rejection at the time of testing in conjunction with standard clinical assessment. AlloMap testing measures the expression levels of 20 genes from a blood sample. The combined expression of these genes is represented as an AlloMap test score. AlloMap is performed in the CareDx CLIA-certified laboratory and has been commercially available in the United States since 2005. AlloMap was cleared by the U.S. Food and Drug Administration in 2008 and was CE marked for the European Union in 2011. Use of AlloMap is also included in the International Society for Heart and Lung Transplantation (ISHLT) Practice Guidelines, published in August 2010, the worldwide standard for the care of heart transplant patients. http://www.allomap.com/
