Sr. Process Engineer

Sr. Process Engineer

Billerica, 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.

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.

• Develop reagent processes and collaborate with Research, Technology and Reagent R&D on IVD and RUO product development.
• Write documentation for IVD and RUO products and processes.
• 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.
• Facilitate root cause analysis and ideation of the improvement opportunities from the metric discussions.

• BS in molecular biology, biochemistry, chemistry, engineering, or a related discipline with 6+ years of experience in product and process development; MS in a related discipline with 5+ years of experience; or PhD in a related discipline with 4+ years of experience.

• Experience in biomolecule diagnostics is ideal.
• Small- and large-scale project or process experience, including manufacturing operations experience.
• Experience collaborating cross-functionally with Research, Technology, Reagent R&D, Technical Operations, Quality, and external stakeholders.
• Experience supporting continuous improvement, supplier technical support, root cause analysis, and process implementation activities.
• Demonstrated technical expertise in process and product development in a regulated environment.
• Experience developing, characterizing, qualifying, and implementing reagent product manufacturing processes.

• Workplace location:
  Billerica, MA; onsite, hybrid, or remote arrangement to be confirmed by the hiring manager.
• Travel: percentage to be confirmed by the hiring manager.
• Physical requirements, including any lifting requirements, to be confirmed by the hiring manager if applicable.
• Self-starter who is flexible in changing direction and methods and thrives in a fast-paced environment.
• Strong technical judgment, documentation discipline, cross-functional collaboration, and problem-solving skills.

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…