Sr Director, Assay DevelopmentBillerica, MAROLE 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)
Pay Range: $225,000 - $265,000 per year
