Sr. Director, Assay Development

Sr Director, Assay Development

Billerica, MA

Quanterix is a global leader in ultra-sensitive biomarker detection, enabling breakthroughs in disease research, diagnostics, and drug development. Its proprietary Simoa technology delivers industry-leading sensitivity, allowing researchers to detect and quantify biomarkers in blood and other fluids at concentrations far below traditional limits. With more than 3,400 peer-reviewed publications, Quanterix has been a trusted partner to the scientific community for nearly two decades.

In 2025, Quanterix acquired Akoya Biosciences, The Spatial Biology Company, adding multiplexed tissue imaging with single‑cell resolution to its portfolio. Together, the combined company offers a uniquely integrated platform that connects biology across blood and tissue‑advancing precision medicine from discovery to diagnostics.

We are seeking an experienced and highly motivated Sr. Director, Assay Development to drive continued growth and expansion of our portfolio of ultrasensitive Simoa immunoassays into IVD validation. This is a high impact role with responsibility for leading development of clinically and commercially significant Simoa biomarker assays. You will use your technical and managerial skills and experience to lead a high‑performing group of Assay Development scientists and to oversee multiple immunoassay development projects for novel biomarkers serving fast‑growing market segments.

The successful candidate will have a deep understanding of best practices and processes associated with bead‑based immunoassay design and development, assay qualification, and successful transfer of assays to manufacturing, with experience supporting regulated IVD development activities. It is important that the candidate leads teams effectively, influences cross‑functionally, and possesses top‑tier technical skills.

• Develop best‑in‑class ultrasensitive immunoassays that increase value of Simoa assay portfolio.
• Partner with RA/QA and cross‑functional teams to support regulated IVD submissions (EU IVDR and FDA 510(k)), including defining requirements, generating performance evidence, and contributing to technical documentation.
• Lead risk assessment, mitigation and troubleshooting activities of high technical and logistical complexity.
• Serve as a subject matter expert within Quanterix for all technical aspects of Simoa biomarker immunoassay development, IVD submissions, Data related to Design History Files, communication with regulatory bodies.
• Collaborate and communicate effectively with cross‑functional stakeholders including Program Management, Product Management, Manufacturing, QC and QA to ensure successful assay progress though Product Development, Transfer to manufacturing, and IVD submissions.
• Drive highest possible standards in data quality using scientifically and statistically appropriate data analysis, interpretation, and reporting techniques and tools.
• Write, review and/or approve Product Requirements, Test Plans and Reports, Data summaries, Technical Protocols and Qualification reports.
• Embody Quanterix values of Accountability, Teamwork, Trust and Transparency.

• Ph.D. in Biology, Biochemistry, or other relevant life science discipline such as Immunology.
• 10+ years of immunoassay development experience in an industrial diagnostic R&D setting (IVD/Diagnostics), including design, development, and verification/validation activities supporting commercialization.
• 5+ years of experience managing people and leading immunoassay development projects
• Demonstrated experience working with established standards related to the development and validation of biomarker assays, including CLSI guidelines, fit‑for‑purpose biomarker method…