Quanterix
Bedford, MA
Quanterix is a global leader in ultra-sensitive biomarker detection, enabling breakthroughs in disease research, diagnostics, and drug development. Its vision is to lead the next era of precision biomarker science to power earlier detection, better decisions, and improved human health. Its mission is to make biology measurable at its most fundamental level, delivering earlier insight when it matters most. Across discovery to clinical applications, Quanterix empowers scientists and healthcare providers to improve patients’ lives through detection and understanding of disease. 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.
ROLE SUMMARY:
WHAT YOU’LL DO:
- 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.
- 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.
- 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.
- 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.
WHY YOU’LL LIKE WORKING WITH US:
Our Commitment to Employees:
DIVERSE & INCLUSIVE WORKPLACE:
Quanterix is committed to a diverse and inclusive workplace. Quanterix is an equal opportunity employer and does not discriminate on the basis of race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status. Quanterix will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
To help us track our recruitment effort, please indicate in your cover/motivation letter where (environmentaljob.net) you saw this job posting.