Consultant - Technical Excellence & Scientific Operations

Consultant - Technical Excellence & Scientific Operations 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: 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. WHY YOU'LL LIKE WORKING WITH US: Our Technology: From discovery to diagnostics, Quanterix's ultrasensitive biomarker detection is fueling breakthroughs only made possible through its unparalleled sensitivity and flexibility. Simoa technology has delivered the gold standard for earlier biomarker detection in blood, serum or plasma, with the ability to quantify proteins that are far lower than the Level of Quantification (LoQ). Our industry-leading precision instruments, digital immunoassay technology and CLIA-certified Accelerator laboratory have supported research that advances disease understanding and management in neurology, oncology, immunology, cardiology, and infectious disease. Akoya Biosciences, a Quanterix company, is The Spatial Biology Company-bringing tissue context to life through high-resolution, single-cell imaging. Akoya's spatial phenotyping platforms help researchers visualize and measure how cells organize and interact within tissue to influence disease progression and therapeutic response. From discovery through clinical research, Akoya offers a full continuum of solutions, including PhenoCycler, PhenoImager Fusion and HT, and PhenoCode Panels. As part of Quanterix, Akoya complements a leading portfolio of ultra-sensitive biomarker detection technologies, together enabling a more complete view of biology and disease across both tissue and blood. Our Commitment to Employees: At Quanterix, our values are based on: Team, Innovation, Customer and Owner. Team: Challenge assumptions, not the person. Respect diversity of thought and hold ourselves to lofty standards Innovation: Stay curious, experiment, create and change Customer: Prioritize and celebrate these pioneers by doing our best to deliver on commitments Owner: Act with high integrity and in the best interest of Quanterix. Take measured risks and learn from their success and failures. We reward and recognize our employees by offering competitive compensation and a 401k plan with employer match. We also offer competitive health, dental, and vision benefits for employees and their dependents. We also offer an unlimited vacation policy to all exempt employees, and a generous PTO policy for non-exempt employees. All employees are eligible for equity, employee stock purchase plan, a performance bonus, and 1:1 financial counseling/planning. We also offer Tuition Assistance. We have a free, state-of-the-art onsite fitness center for all employees. To keep you fueled up, we provide onsite employees free snacks and drinks every day! DIVERSE & INCLUSIVE WORKPLACE: Quanterix is committed to a Diverse and Inclusive workplace. We strive to recruit candidates who will bring inclusive mindsets and contribute to our values. Quanterix is an Equal Opportunity Employer and does not discriminate based on 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. #J-18808-Ljbffr Quanterix