Senior Scientist, Assay Development

As a Senior or Staff Development Scientist, you will be part of the Assay Development team for the product development of Delfi Diagnostic’s Lung Cancer Screening Test medical device. You will play a critical role in leading the development and optimization of robust multiomics molecular diagnostic assays for in vitro diagnostic (IVD) applications. The ideal candidate will have a strong scientific foundation in Next-Generation Sequencing (NGS) with liquid biopsies for genomic and proteomic,  technical leadership, and experience working under a Design Control framework to develop and validate regulated diagnostic products. This is a lab based position with some hybrid flexibility. This role is expected to be onsite 5 days a week when needed for laboratory work.

What you’ll do

- Design, develop, optimize assay, reagent, and quality control parameters to set tolerance limits and meet performance requirements for complex multiomic assays.

- Develop robust processes for reagent manufacturing, reagent QC, and transfer to contract reagent manufacturers.

- Perform rigorous design of experiment, data analysis, and act as subject matter expert by collaborating with assay biostatisticians, bioinformaticians, engineers, and scientists to determine key assay performance characteristics.

- Document product development requirements and author study protocols and reports to ensure traceability and compliance with industry standards

- Be accountable for development activities and advance the assay through design control processes to meet product requirements and project milestones by contributing to plans, risk assessment, and verification activities.

What you’ll have accomplished 12 months from now

- Led the identification of critical to quality parameters, optimization, and development of specification limits to control the assay and reagent manufacturing processes.

- Be the subject matter expert for Delfi Diagnostic’s Lung Cancer Screening Test key performance metrics across multiple subsystems and the integration of multiple omics under one medical device.

- Be able to understand regulatory requirements, perform risk assessments, and participate in the elaboration of plans and data-driven decisions to prioritize IVD development.

What you’ll bring to DELFI

- Required

- PhD with 5+ years or Master’s with 8+ years industry assay development experience experience in Molecular Biology, Biochemistry, Chemistry, or a similar discipline.

- Deep understanding of developing NGS cfDNA/multi-omic assay technologies from plasma (e.g., DNA fragments, RNA, small variants, methylation, and immunoassays).

- Hands-on with reagent development and assay optimization with IVD or LDT product development experience, working in a regulated laboratory environment (GLP).

- Experience in writing protocols, designing experiments, analyzing, and documenting results in reports.

- Clear communication skills, ability to work with team members in the same and adjacent disciplines, and experience mentoring and training junior scientists and other cross-functional stakeholders, fostering a collaborative, knowledge-sharing and data-driven culture.

- Ability to work on-site at our Palo Alto laboratory five days a week when required to be hands-on in the laboratory, and travel to the Baltimore office periodically.

- Preferred

- Experience validating or establishing key performance characteristics such as LoB, LoD, LoQ, and linearity for quantitative assays.

- Experience establishing sample intermediates, safe stopping points, reagent shelf life, and in-use reagent stability specifications.

- Data analysis capabilities using languages such as R, Python, or JMP.

- Developing or executing assays using automated liquid handlers is preferred.

- Product transfer in a regulated and/or ISO-compliant environment

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

This position is not eligible for agency partnership. Resumes and outreach from staffing representatives will be declined.

Total Compensation at DELFI is a combination of salary, bonus, equity, and benefits. Actual compensation packages are based on a wide array of factors unique to each candidate, including but not limited to skillset, years & depth of experience, certifications & relevant education, geography.