Assay Manager Jobs (NOW HIRING)

Sr Director, Assay Development
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 an experienced and highly motivated Sr. Director, Assay Development to drive continued growth and expansion of our portfolio of ultrasensitive Simoa immunoassays into IVD validation. This is a high impact role with responsibility for leading development of clinically and commercially significant Simoa biomarker assays. You will use your technical and managerial skills and experience to lead a high-performing group of Assay Development scientists and to oversee multiple immunoassay development projects for novel biomarkers serving fast-growing market segments. The successful candidate will have a deep understanding of best practices and processes associated with bead-based immunoassay design and development, assay qualification, and successful transfer of assays to manufacturing, with experience supporting regulated IVD development activities. It is important that the candidate leads teams effectively, influences cross-functionally, and possesses top-tier technical skills.
WHAT YOU'LL DO:

• Develop best-in-class ultrasensitive immunoassays that increase value of Simoa assay portfolio.
• Partner with RA/QA and cross-functional teams to support regulated IVD submissions (EU IVDR and FDA 510(k)), including defining requirements, generating performance evidence, and contributing to technical documentation.
• Lead risk assessment, mitigation and troubleshooting activities of high technical and logistical complexity.
• Serve as a subject matter expert within Quanterix for all technical aspects of Simoa biomarker immunoassay development, IVD submissions, Data related to Design History Files, communication with regulatory bodies.
• Collaborate and communicate effectively with cross-functional stakeholders including Program Management, Product Management, Manufacturing, QC and QA to ensure successful assay progress though Product Development, Transfer to manufacturing, and IVD submissions.
• Drive highest possible standards in data quality using scientifically and statistically appropriate data analysis, interpretation, and reporting techniques and tools.
• Write, review and/or approve Product Requirements, Test Plans and Reports, Data summaries, Technical Protocols and Qualification reports.
• Embody Quanterix values of Accountability, Teamwork, Trust and Transparency.

BASIC QUALIFICATIONS:

• Ph.D. in Biology, Biochemistry, or other relevant life science discipline such as Immunology.
• 10+ years of immunoassay development experience in an industrial diagnostic R&D setting (IVD/Diagnostics), including design, development, and verification/validation activities supporting commercialization.
• 5+ years of experience managing people and leading immunoassay development projects
• Demonstrated experience working with established standards related to the development and validation of biomarker assays, including CLSI guidelines, fit-for-purpose biomarker method validation, ISO9001, ISO13485, and FDA data reporting requirements.

PREFERRED QUALIFICATIONS:

• Experience supporting regulated IVD products under EU IVDR and/or FDA frameworks, including partnering with RA/QA on technical documentation (e.g., performance evaluation/validation evidence) and requirements to enable CE marking and market access
• Experience of successfully leading development of products within a stage-gate process is required.
• Familiarity with the field of protein biomarkers for neurodegeneration, infectious disease, or cancer is strongly preferred.

EXPECTATIONS, COMPETENCIES, SKILLS & ABILITIES:

• Broad subject matter expertise in key technical aspects of commercial immunoassay development, including protein chemistry, antibody screening, antibody: bead conjugation, assay diluent formulation, multiplexing, preanalytical sample processing, scale-up, assay optimization, troubleshooting, multivariate data analysis, and analytical and clinical validation.
• Experience supporting regulated IVD products under EU IVDR and/or FDA frameworks, including design controls, analytical/clinical performance evidence, and partnering with RA/QA on technical documentation to enable CE marking, market access, and submission readiness.
• Understanding of the US clinical diagnostics landscape, including Laboratory Developed Tests (LDTs), CLIA laboratory considerations, and single-site IVD development and validation approaches, including method verification, reference intervals, QC, and documentation requirements aligned with intended use and risk.
• Ability to manage multiple outcomes while achieving overall organizational objectives
• Exceptional verbal and written communication skills; able to clearly and proactively communicate and to explain complex data and technical details.
• Ability to value relationships and to work collaboratively and effectively with a wide constituency of internal and external stakeholders.
• Strong proficiency with Microsoft Office tools required; experience with Document Control (e.g., Master Control) and ERP software (e.g., Syteline) strongly preferred.
• Ability to effectively communicate organizational requirements, policies, and procedures.
• Work 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.
Pay Range: $225,000 - $265,000 per year