Senior Scientist, Assay Development (NGS)

Location: Palo Alto, California, United States; onsite. The role is expected to be onsite five days a week when laboratory work is needed.

Company

hirify.global develops molecular diagnostic products focused on early cancer detection.

What you will do

• Design, develop, and optimize assay, reagent, and quality-control parameters for complex multiomic assays.
• Execute analytical validation, design verification, and design transfer activities.
• Collaborate with R&D, Lab Operations, Biostatistics, Quality, and Regulatory teams on study plans.
• Draft study protocols, validation reports, data summaries, and Formal Design Review materials.
• Contribute to FDA PMA submission packages and design control activities throughout the product lifecycle.
• Provide technical guidance and mentorship on validated methods and best practices.

Requirements

• Doctoral degree in Molecular Biology or a related field, or a relevant master's or bachelor's degree with the required experience.
• At least two years of experience developing molecular or genomic assays.
• Hands-on NGS assay development experience, ideally involving liquid biopsies and genomic or multiomic assays.
• Experience with design of experiments, assay optimization, and data-driven decision-making.
• Working knowledge of Design Control and regulated product development, including FDA 21 CFR Part 820, ISO 14971, ISO 13485, and IVDR.
• Strong analytical, problem-solving, collaboration, and communication skills.

Nice to have

• Experience with multiomics assay integration.
• Experience with cfDNA or fragmentomics-based assays.
• Exposure to design verification and FDA PMA submissions.

Culture & Benefits

• Science-led culture focused on quality, transparency, rigor, and practical impact.
• Collaborative environment built around cross-functional teamwork, empathy, humility, and integrity.
• One to two designated in-office working days each week for employees living within 50 miles of the Palo Alto or Baltimore offices, with additional onsite laboratory work required for this role.