Reports to: VP, Product Development
FLSA: Exempt
Location: San Diego
Position Summary:
We are seeking a highly skilled Senior Scientist, Product Development with expertise in Molecular Diagnostics to lead the development and optimization of cutting-edge molecular assays for early cancer detection. The successful candidate will play a key role in assay development, verification, validation, and regulatory submissions, working cross-functionally with R&D, bioinformatics, regulatory, quality, and laboratory operation teams. The position requires frequent and close collaboration across departments and is best suited for a candidate who can efficiently work in a goal-oriented setting.
Key Responsibilities
Assay Development & Optimization
- Lead the design, development, and optimization of molecular diagnostic assays (e.g., NGS).
- Evaluate and optimize sample preparation, extraction, and amplification methodologies.
- Conduct feasibility studies and proof-of-concept experiments.
- Develop robust, reproducible, and scalable workflows for diagnostic applications.
- Execute verification and validation (V&V) studies in accordance with regulatory and industry standards (e.g., FDA, IVDR, CLIA).
- Analyze data, troubleshoot assay performance issues, and implement solutions.
- Contribute to development of target product profiles
- Ensure development activities comply with FDA, CLIA, CAP, IVDR, and ISO 13485 requirements.
- Author and review technical documents, study protocols, and reports for regulatory submissions.
- Partner with quality and regulatory teams to support product approvals and audits.
- Work closely with research department, bioinformatics, engineering, and laboratory operations
- Engage with external partners, KOLs, and industry stakeholders.
- Deep knowledge of molecular technologies, such as NGS, RNA-Seq, qPCR, ddPCR, and epigenomic assays.
- Minimum 2 years of supervisory or project leadership experience.
- Experience with laboratory automation and workflow integration.
- Ability to evaluate vendors, technologies, and assays for commercial feasibility.
- Ph.D. in Molecular Biology, Biochemistry, Genetics, or related field with 3-5+ years of industry experience, or
- M.S. with 6+ years of relevant experience in molecular diagnostics product development
Top Skills
What We Do
ClearNote Health – Cancer detection company enabling people at risk for high-mortality cancers to live longer, healthier lives.
We focus on developing non-invasive tests to detect cancer through a standard blood draw earlier than existing methods by harnessing the power of epigenomics. We apply our proprietary epigenomic platform, combining biology and artificial intelligence, to identify DNA-based changes in biology as cancer develops.
With lead programs in non-invasive early detection of pancreatic and ovarian cancers in patients at the highest risk for these diseases. Headquartered in the U.S, the company’s CLIA and CAP-accredited laboratory is located in San Diego, Calif., with additional presence in the San Francisco Bay Area and internationally.
#biotechnology #epigenomics #oncology #cancerresearch #cancer
