Director, Assay Development

Quanterix
tuition assistance, 401(k)
United States, Massachusetts, Billerica
Sep 24, 2024
Director of Assay Development Billerica, MA, USA Quanterix is revolutionizing biomarker analysis to advance precision health, leveraging Simoa technology for ultra-sensitive protein detection. This transformative technology aims to enable earlier disease detection, better prognoses, and precise treatments, with goal of significantly improving quality of life and longevity. We are on a mission to change the way in which healthcare is provided by giving researchers the ability to closely examine the continuum from health to disease. To make this vision a reality, we brought together the most experienced management team, renowned scientists, industry leading investors and expert advisors from around the globe to, to form a collaborative ecosystem, united through the common goal of advancing the science of precision health. ROLE SUMMARY: We are looking for an experienced and highly motivated Director of Assay Development to join our Reagent R&D team in Billerica, MA. This is a high impact role with responsibility for leading development of clinically and commercially significant Simoa biomarker assays. The candidate will use 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. WHAT YOU'LL DO: Develop best-in-class ultrasensitive immunoassays that increase value of Simoa assay portfolio. Lead, mentor and inspire high-performing team of assay development scientists to meet new product launch and quality objectives for Simoa assays. Manage resources to achieve timely execution of roadmap activities, managing multiple projects simultaneously. 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. 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 Process and transfer to manufacturing. 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. Provide regular verbal and written updates to key stakeholders and team/s, including project status, progress, risks, and timelines. Maintain and help drive a culture of excellence and continuous improvement within the Assay Development team. 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 setting (e.g., in vitro diagnostic, clinical trials, contract research, or pharmaceutical/biotechnology). 5+ years of experience in effectively managing people and directly leading immunoassay development projects. Demonstrated fluency in and experience working with established standards associated with development and validation of biomarker assays, including but not limited to CLSI guidelines, Fit-for-purpose biomarker method validation, ISO9001 and ISO13485 and FDA data reporting requirements. Experience of successfully leading development of products within a stage-gate process is required. Subject matter expertise and thought leadership in the field of protein biomarkers for neurodegeneration, infectious disease, or cancer is strongly preferred. PREFERRED QUALIFICATIONS: Deep subject matter expertise in multiple key technical aspects of commercial immunoassay development; including but not limited to protein chemistry, antibody screening, antibody: bead conjugation, assay diluent formulation; multiplexing; preanalytical sample processing; scale-up, assay optimization and troubleshooting; multivariate data analysis; analytical validation; clinical validation. Ability to manage towards 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. EXPECTATIONS, COMPETENCIES, SKILLS & ABILITIES: Ability to work onsite 5 days a week. 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. 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.