• 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.

Basic Qualifications:

• Ph.D. in Biology, Biochemistry, Immunology or other relevant life science discipline
• 5-8 years of immunoassay development and/or validation experience in an industrial setting
• 3+ years of clinical assay experience

Preferred Qualifications:

• 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.