Principal Scientist​/Director – Assay Development Engineer; IVD

Job Title: Principal Scientist / Director – Assay Development Engineer (IVD)

Job Number: 37487

Location: ,MA 01803

Job Description

This is a senior-level hire (Principal Scientist to Director) for an experienced assay development leader who can contribute strategically and hands‑on across assay design, analytical performance, validation, and platform integration. This individual will play a key role in advancing complex immunoassays from early development through scalable product‑ready implementation.

Responsibilities

• Lead development and optimization of quantitative immunoassays, including sandwich and competitive assay formats for challenging biomarkers
• Drive assay design around binding kinetics, dynamic range, calibration strategy, surface chemistry, and robustness
• Own analytical verification and validation activities, including precision, sensitivity, interference, recovery, and method performance studies
• Build and refine calibration models and analytical frameworks for novel assay formats
• Partner cross‑functionally with engineering, microfluidics, manufacturing, and product teams to translate assays from prototype to scalable product
• Contribute to technical strategy, experimental design, data interpretation, and broader platform decision‑making
• Support documentation and quality systems aligned with regulated diagnostic product development

Required Skills

• PhD (or equivalent advanced training) in Biochemistry, Analytical Chemistry, Bioengineering, Chemical Engineering, or related discipline
• Significant industry experience in assay development, with leveling appropriate for Principal Scientist through Director
• Deep expertise in immunoassay development, ideally including competitive or complex assay formats
• Strong background in analytical method development, validation, and data‑driven assay optimization
• Experience operating in regulated IVD, diagnostics, or adjacent product development environments preferred
• Familiarity with statistical analysis tools and data environments (Python, R, MATLAB or similar) a plus

• Experience developing assays on novel or emerging diagnostic platforms
• Background interfacing closely with multidisciplinary engineering teams
• Comfortable operating both strategically and hands‑on in a fast‑moving, innovation‑driven environment
• Leadership potential to influence scientific direction, mentor others, and help shape assay platform growth

• Opportunity to help shape a novel diagnostics platform at an inflection point
• High‑visibility role with broad scientific ownership
• Blend of hands‑on science, platform strategy, and product impact
• Ability to work on technically challenging problems where innovation is core, not incremental

This is an opportunity for a senior assay development scientist who wants to help build and scale something differentiated, while operating at a level commensurate with Principal Scientist or Director responsibility.