Sr. Process Engineer - Assay Manufacturing

Quanterix; Billerica (MA); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

401k with employer match

Health, dental & vision benefits

Unlimited vacation policy

Generous PTO

Equity and stock purchase plan

Tuition assistance

Job summary

Quanterix seeks a Sr. Process Engineer - Assay Manufacturing in Billerica, MA. You will lead development, scale-up, and optimization of diagnostic assay manufacturing lines, bridging R&D and commercial production to ensure robust, scalable processes compliant with cGMP and ISO 13485.

You will troubleshoot complex issues, implement automation, and drive continuous improvement for high-quality diagnostic products while collaborating across functions for technology transfers and launches.

Qualifications

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

Responsibilities

• Design, develop, and validate manufacturing processes for complex biological assays for scale-up to commercial production.
• Ensure manufacturing activities comply with cGMP, FDA regulations, and ISO standards.
• Lead IQ/OQ/PQ validation of automated liquid handlers and plate washers.
• Troubleshoot process deviations, perform root-cause analysis, and implement CAPAs.
• Author SOPs, Batch Records, Work Instructions, and validation protocols/reports.
• Identify cost reductions and efficiency gains via Lean and Six Sigma, and pursue automation.
• Collaborate with R&D, QA, and Supply Chain for tech transfers and launches.

Skills

Automation experience

Scale-up

CAPA investigations

Education

Bachelor's in Chemical Engineering or related

Tools

Minitab

JMP

Job description

Sr. Process Engineer - Assay Manufacturing

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 seeking a highly skilled Sr. 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.

WHAT YOU'LL DO:

• Process Development & Scale-Up: Design, develop, and validate manufacturing processes for complex biological assays, moving products from R&D prototypes to full-scale commercial production.
• cGMP Compliance: Ensure all manufacturing activities, equipment, and documentation strictly adhere to current Good Manufacturing Practices (cGMP), FDA regulations, and ISO standards.
• Equipment Validation (IQ/OQ/PQ): Lead the installation, operational, and performance qualification of automated liquid handlers, plate washers, and other specialized assay manufacturing equipment.
• Technical Troubleshooting: Act as the subject matter expert (SME) for root-cause analysis of process deviations and yield excursions. Implement effective Corrective and Preventive Actions (CAPA).
• Documentation: Author and review Standard Operating Procedures (SOPs), Batch Records, Work Instructions, and Process Validation protocols/reports.
• Continuous Improvement: Identify opportunities for cost reduction and efficiency gains through Lean Manufacturing, Six Sigma methodologies, and the integration of new technologies or automation.
• Cross-Functional Collaboration: Work closely with R&D, Quality Assurance, and Supply Chain to ensure seamless technology transfers and product launches

BASIC QUALIFICATIONS:

• Education: Bachelor's degree in Chemical Engineering, Bioengineering, Biotechnology, or a related scientific discipline. (Master's preferred).
• Experience: Minimum 8 years of experience in a process engineering role within a cGMP-regulated environment (e.g., IVD, medical device, or pharmaceutical industry).
• Regulatory Knowledge: 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 f 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.

EXPECTATIONS, COMPETENCIES, SKILLS & ABILITIES:

• 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.
• Must be able to work in a cleanroom environment (ISO 7/8).
• Occasional lifting of equipment (up to 25 lbs) may be required.
• Adherence to strict gowning and safety protocols is mandatory.
• Work location: Billerica, MA (Onsite 5 days)
• Travel 10%

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:

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.