New

IVD Process Engineer

Quanterix
tuition assistance, 401(k)
United States, Massachusetts, Billerica
900 Middlesex Turnpike (Show on map)
Jun 04, 2026
IVD Process Engineer Billerica, MA Quanterix is a global leader in ultra-sensitive biomarker detection, enabling breakthroughs in disease research, diagnostics, and drug development. 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: We are looking for an experienced and motivated candidate to join our Process Development team. In this critical role, this individual will drive the development and deployment of our IVD reagent supply and manufacturing processes, from the lab bench through to production scale. You will design and execute experiments and drive innovations to continuously advance process characterization and scale up methodology in an FDA-regulated environment. You will identify technical requirements in our products, define appropriate methods, and work with internal and external stakeholders to enable a sustainable reagent operations process. WHAT YOU'LL DO: Develop reagent processes and collaborate with Research, Technology and Reagent R&D on IVD and RUO product development. Define requirements and documenting process for IVD and RUO products. Deploy analytical test systems in collaboration with Research, Technology and Reagent R&D, Technical Operations and Quality to characterize and qualify reagent components. Implement reagent product manufacturing processes, including formulation, filling/finishing, and packaging processes for both IVD and RUO products. Continuously improve the reagent manufacturing including supplier technical support, process development and implementation. Includes working with suppliers on consumables. Facilitate root cause analysis and ideation of the improvement opportunities from the metric discussions. BASIC QUALIFICATIONS: BS in molecular biology, biochemistry, chemistry, or engineering. 15+ years of experience. MS in chemistry/biology technology disciplines as above, with 12+ years of experience. PhD in chemistry/biology technology disciplines as above, with 8+ years of experience. 5+ years of experience in product and process development. PREFERRED QUALIFICATIONS: Experience in IVD and/or RUO product and process development Experience developing reagent manufacturing processes in a regulated environment Knowledge of reagent formulation, fill/finish, and packaging processes Experience with process characterization, qualification, and scale-up Familiarity with analytical test methods for reagent/component evaluation Experience supporting manufacturing operations and process transfer Knowledge of biomolecule diagnostics or related assay technologies Experience partnering cross-functionally with R&D, Operations, Quality, and suppliers Strong root cause analysis and continuous improvement skills Advanced degree in molecular biology, biochemistry, chemistry, or engineering preferred EXPECTATIONS, COMPETENCIES, SKILLS & ABILITIES: IVD/RUO reagent process development Process characterization and analytical methods Reagent formulation and scale-up FDA-regulated product/process development Technical problem solving and troubleshooting Root cause analysis and process optimization Manufacturing process transfer and implementation Biomolecule diagnostic systems knowledge Demonstrated technical expertise as well as management experience. Significant experience in product and process development. Experience in biomolecule diagnostics is ideal. Both small/large-scale project/process experience and manufacturing operations experience. Individuals applying for this position must be self-starters, flexible in changing direction and methods and thrive in a fast-paced environment Workplace location: Billerica, MA Travel 10% Must lift 25 amount pounds (if applicable) 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, as well as 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.