Sr. Scientist Product Development
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
Come join us in addressing large healthcare needs through precision epigenomic medicine!
ClearNote Health is an exciting life science company that is reinventing non-invasive molecular diagnostic testing using next generation epigenomic technologies. We are passionate and dedicated to discovering and developing medicines that will make a significant difference in cancer and other epigenomic-driven diseases. Our technologies provide novel insight and quantitation of human health and disease, with our focus on precision medicine applications improving both clinical and health system outcomes. Our company was founded based on pioneering work in the Stanford laboratory of Stephen Quake, with advisors from Stanford and UCSF.
We look for extraordinary lifelong learners with a passion and growth mindset for these areas, and for combining biological ingenuity with AI and data analysis. Led by a team with decades of experience bringing products from concept to market, we are an equal opportunity employer and value diversity at our company.
We provide generous benefits to all employees including stock options. We are building a world-class company, based in San Diego and San Mateo.
Our commitment to Diversity, Equity, Inclusion, and Belonging:
We celebrate diversity in perspectives and backgrounds, and this is reflected in our innovation, our mission, and values. Our differences make us unique, help us innovate, and allow us to persevere. We strive to achieve representation and inclusion and redefine the possible in patients living longer lives.