Sr. Process Engineer - Assay Manufacturing

About the Role

We are seeking a highly skilled Senior Process Engineer - Assay Manufacturing to lead the development, scale-up, and optimization of our diagnostic assay manufacturing lines. The ideal candidate will bridge the gap between R&D and commercial production, ensuring that all manufacturing processes are robust, scalable, and fully compliant with cGMP and ISO 13485 standards. You will be responsible for troubleshooting complex technical issues, implementing automation, and driving continuous improvement to ensure the highest quality of our diagnostic products.

Responsibilities

• Design, develop, and validate manufacturing processes for complex biological assays, moving products from R&D prototypes to full-scale commercial production.
• Ensure all manufacturing activities, equipment, and documentation strictly adhere to current Good Manufacturing Practices (cGMP), FDA regulations, and ISO standards.
• Lead the installation, operational, and performance qualification (IQ/OQ/PQ) of automated liquid handlers, plate washers, and other specialized assay manufacturing equipment.
• Act as the subject matter expert (SME) for root-cause analysis of process deviations and yield excursions; implement effective Corrective and Preventive Actions (CAPA).
• Author and review Standard Operating Procedures (SOPs), Batch Records, Work Instructions, and Process Validation protocols/reports.
• Identify opportunities for cost reduction and efficiency gains through Lean Manufacturing, Six Sigma methodologies, and the integration of new technologies or automation.
• Work closely with R&D, Quality Assurance, and Supply Chain to ensure seamless technology transfers and product launches.
• Must be able to work in a cleanroom environment (ISO 7/8).
• Occasional lifting of equipment (up to 25 lbs) may be required.
• Adhere to strict gowning and safety protocols.

Requirements

• Bachelor’s degree in Chemical Engineering, Bioengineering, Biotechnology, or a related scientific discipline (Master’s preferred).
• Minimum 8 years of experience in a process engineering role within a cGMP-regulated environment (e.g., IVD, medical device, or pharmaceutical industry).
• Deep familiarity with FDA 21 CFR Part 820 and/or ISO 13485 requirements.

Preferred Qualifications

• Direct experience with assay chemistry, reagent formulation, or diagnostic kit assembly.
• Hands-on experience with automated manufacturing platforms and liquid handling systems.
• Strong understanding of Statistical Process Control (SPC) and Design of Experiments (DoE).
• Experience with Six Sigma or Lean Manufacturing certification (Green/Black Belt).
• Proficiency in statistical software such as Minitab or JMP.
• Background in lyophilization processes or coating technologies.
• Strong project management skills and the ability to lead cross-functional teams.

Skills & Competencies

• Strong judgment, accountability, and attention to detail in a regulated manufacturing environment.
• Effective communication and collaboration across technical and cross-functional teams.
• Strong problem-solving and decision-making skills with the ability to assess risk and recommend practical solutions.
• Ability to manage multiple priorities, adapt to changing business needs, and meet deadlines.
• Professionalism, sound judgment, and the ability to handle sensitive information with discretion.
• Continuous learning mindset with a focus on quality, process improvement, and operational excellence.

Schedule

Work location: Billerica, MA (Onsite 5 days a week). Travel: 10%.

Benefits

• Competitive compensation and a 401k plan with employer match.
• Competitive health, dental, and vision benefits for employees and their dependents.
• Unlimited vacation policy for all exempt employees, and a generous PTO policy for non-exempt employees.
• Eligibility for equity, employee stock purchase plan, and performance bonus.
• 1:1 financial counseling/planning.
• Tuition assistance.
• Free, state-of-the-art onsite fitness center for all employees.
• Free snacks and drinks provided daily for onsite employees.

About the Company

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.

Our values are based on: Team, Innovation, Customer, and Owner. We challenge assumptions, respect diversity of thought, and hold ourselves to lofty standards. We prioritize and celebrate our customers, act with high integrity, and take measured risks while learning from successes and failures.

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. We make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.