Senior Director, Ultra-Sensitive Immunoassay Development

Quanterix; Billerica (MA); On-site; USD 220,000 - 320,000; Full time

Job summary

Quanterix in Billerica, MA seeks a Sr Director of Assay Development to lead development of ultrasensitive Simoa immunoassays for IVD validation and commercial transfer. This role manages a high‑performing team and directs multi‑project biomarker programs with cross‑functional partners across regulatory, QA, and manufacturing.

The candidate will drive data‑driven decisions, establish development standards, and ensure compliance with CLSI, ISO, and FDA requirements, while shaping the strategy for

Qualifications

• PhD in a life science discipline with 10+ years of industrial immunoassay R&D experience.
• Experience leading immunoassay development projects and teams.
• Familiarity with CLIA/ISO standards and regulatory documentation.

Responsibilities

• Develop best-in-class ultrasensitive Simoa immunoassays and drive portfolio value.
• Lead cross-functional teams to support IVD submissions and documentation.
• Ensure data quality and statistical rigor in analyses and reporting.
• Collaborate with RA/QA, manufacturing, and product teams to advance development.

Skills

Bead-based immunoassay

IVD development

Regulatory submissions

Team leadership

Data analysis

Cross-functional collaboration

Education

PhD in Biology/ Biochemistry/ Immunology

PhD required for leadership role

Tools

MS Office

Master Control

ERP (Syteline)

Job description

Quanterix in Billerica, MA seeks a Sr Director of Assay Development to lead development of ultrasensitive Simoa immunoassays for IVD validation and commercial transfer. This role manages a high‑performing team and directs multi‑project biomarker programs with cross‑functional partners across regulatory, QA, and manufacturing.

The candidate will drive data‑driven decisions, establish development standards, and ensure compliance with CLSI, ISO, and FDA requirements, while shaping the strategy for