Consultant - Technical Excellence & Scientific Operations
Bedford, MA
ROLE SUMMARY:

Quanterix is seeking an accomplished scientific expert to serve as Consultant - Technical Excellence & Scientific Operations within Accelerator Laboratory Services. This role provides technical leadership across custom assay development and clinical testing operations, ensuring scientific rigor, operational excellence, and regulatory readiness throughout the biomarker development lifecycle.

Reporting to the Vice President of Laboratory Services, the Consultant will serve as a technical authority on the Simoa platform, partnering closely with Custom Assay Development, Laboratory Operations, Project Management, Quality, Regulatory, and Commercial teams. The Consultant will mentor scientists and program leaders, remove technical roadblocks, establish technical standards and best practices, and drive continuous improvement initiatives that increase laboratory capacity, improve assay robustness, and accelerate customer program delivery.

The Consultant will also provide technical oversight of analytical validation activities supporting laboratory-developed tests (LDTs) and FDA submissions, including review of validation strategies, analytical data, validation reports, and technical documentation supporting regulatory submissions.

This position is designed for a highly experienced Simoa expert who enjoys solving complex scientific challenges, mentoring technical teams, and translating scientific expertise into scalable operational excellence.

WHAT YOU'LL DO:

Technical Excellence & Scientific Leadership

• Serve as a senior technical authority for SIMOA-based biomarker assay development across research, translational, clinical trial, and diagnostic programs.
• Provide technical leadership and scientific guidance to Custom Assay Development teams, accelerating program execution through effective troubleshooting and mentorship.
• Review experimental strategies, analytical data, and assay performance to ensure scientific rigor, robustness, and reproducibility.
• Partner with scientists and program leaders to resolve complex technical challenges and remove barriers impacting project timelines.
• Establish technical standards, best practices, and scientific governance that improve consistency across assay development and laboratory testing.
• Mentor scientists and technical leaders, fostering a culture of scientific excellence and continuous learning.

Scientific Operations & Continuous Improvement

• Lead initiatives that improve operational efficiency across sample testing laboratories while maintaining the highest scientific standards.
• Drive continuous improvement initiatives including optimization of calibration strategies, quality control approaches, assay standardization, and laboratory workflows.
• Identify opportunities to increase laboratory capacity, improve throughput, and enhance assay reproducibility through technical innovation and process optimization.
• Partner with laboratory leadership to implement scalable technical solutions supporting organizational growth.

Analytical Validation & Regulatory Support

• Provide technical oversight of analytical validation studies supporting laboratory-developed tests and FDA submissions.
• Review validation protocols, analytical datasets, statistical outputs, and validation reports to ensure scientific integrity and regulatory readiness.
• Partner with Regulatory Affairs and Quality to ensure technical documentation is complete, scientifically sound, and submission ready.
• Support development and review of analytical data packages supporting FDA 510(k) and other regulatory submissions.
• Ensure technical consistency and scientific defensibility across validation activities.

Cross-Functional Leadership

• Collaborate closely with Laboratory Operations, Project Management, Commercial, Regulatory, Quality, and Scientific Leadership teams.
• Support prioritization of technical resources across multiple development programs.
• Provide technical input during strategic planning and operational decision-making.
• Promote alignment between assay development and testing operations to improve execution, scientific quality, and customer outcomes.

BASIC QUALIFICATIONS:

• Ph.D. or M.S. in Biochemistry, Molecular Biology, Immunology, Analytical Chemistry, Biomedical Engineering, or a related scientific discipline.
• Minimum of 10 years of experience in biomarker assay development, analytical sciences, or regulated laboratory environments.
• Extensive hands-on experience developing assays on the SIMOA platform.
• Demonstrated experience supporting analytical validation and regulated laboratory activities.
• Proven ability to provide technical leadership across multidisciplinary scientific teams.

PREFERRED QUALIFICATIONS:

• Experience within Quanterix, a CRO, diagnostics company, or biomarker-focused organization.
• Extensive experience supporting clinical trial biomarker programs.
• Experience supporting analytical validation for LDTs and FDA submissions, including 510(k) programs.
• Strong understanding of bioanalytical validation principles and regulated laboratory operations.
• Demonstrated success implementing technical and operational improvements within laboratory environments.
• Experience mentoring scientists and technical leaders.
• Excellent analytical, communication, and scientific problem-solving skills.

EXPECTATIONS, COMPETENCIES, SKILLS & ABILITIES:

• Recognized technical expert in SIMOA assay development and analytical validation.
• Ability to influence scientific and operational decisions across functions without direct organizational authority.
• Strong mentoring and coaching abilities.
• Excellent scientific judgment and attention to detail.
• Passion for continuous improvement and operational excellence.
• Exceptional collaboration and stakeholder management skills.
• Strong organizational, analytical, and decision-making capabilities.
• Ability to manage multiple complex priorities in a fast-paced environment.
• Proficiency with scientific data analysis, laboratory information systems, and Microsoft Office applications.

Pay Range: $91.35 - $106.00 per hour