Senior Scientist

Quanterix is a company that is digitizing biomarker analysis with the goal of advancing the science of precision health. The company's ultra-sensitive detection solution, Simoa, has the potential to change the way in which healthcare is provided today by giving researchers the ability to closely examine the role of biomarkers in the continuum of health to disease. Quanterix' technology is designed to enable much earlier disease detection, better prognosis and precise treatment methods to improve the quality of life and longevity of the population for generations to come. The technology is currently being used for research applications in several therapeutic areas, including oncology, neurology, cardiology, inflammation and infectious disease. We are looking for an experienced and highly motivated Senior Scientist, Clinical Assay Validation to lead efforts validating and sustaining clinical assays offered through Quanterix's Accelerator Laboratory. Initially this role will focus on tests that will be run as Laboratory Developed Tests (LDTs) through Quanterix' CLIA laboratory. Future products will include FDA-cleared IVD tests. You will use your technical skills to oversee the validation of novel immunoassays to expand and maintain the company's clinical assay menu. The company has launched several blood-based neurology biomarker LDTs and intends to continue to expand its offerings in response to market demand. The successful candidate will have a deep understanding of best practices and processes associated with clinical immunoassay design, development and validation. What You'll Do: Validate ultrasensitive blood-based biomarker immunoassays, focused initially in neurology, for a variety of clinical testing applications including clinical trials and clinical care Lead the validation of biomarker assays, following appropriate regulatory guidelines (e.g., CLSI). Also, lead the risk assessment, mitigation and troubleshooting activities for use of the validated assays in a CLIA testing operation Compile, analyze and review clinical assay performance data gathered as part of clinical testing operations, recommend potential updates or changes in testing procedures as needed Work with cross-functional team members including Program Management, Product Management, Manufacturing, Laboratory Operations, and Quality Assurance to ensure successful assay launches Drive highest possible standards in data quality using scientifically and statistically appropriate data analysis, interpretation, and reporting techniques and tools. Write Product Requirements, Test Plans and Reports, Data summaries, Technical Protocols and Qualification reports. Provide regular verbal and written updates to key stakeholders and team/s, including project status, progress, risks, and timelines. What We'll Expect From You: Ph.D. in Biology, Biochemistry, or other relevant life science discipline such as Immunology 5+ years of immunoassay development and/or validation experience in an industrial setting including at least 3 years of clinical assay experience Strong skills with data analysis tools and biostatistical analysis methods, including characterizing and representing clinical assay performance; proficiency with laboratory information systems Demonstrated fluency in and experience working with established standards associated with development and validation of clinical biomarker assays, including but not limited to CLSI guidelines, ISO13485 and FDA data reporting requirements Experience successfully leading projects within a stage-gate process Why You'll Like Working For Us: Our Technology: Quanterix' technology is designed to enable much earlier disease detection, better prognoses and enhanced treatment methods to improve the quality of life and longevity of the population for generations to come. The technology is currently being used for research applications in several therapeutic areas. The company was established in 2007 and is in Billerica, Massachusetts. For additional Information, please visit . Our Commitment to Employees: At Quanterix, we take pride in our employees' incredible work ethic, and we want to reward and recognize that by offering competitive compensation and a 401k plan with an 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 awarded Equity, and we have an 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. Quanterix is committed to a Diverse and Inclusive workplace. 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.