Director, Assay Development - Billerica, United States - Quanterix

Description

Job Description

DIRECTOR, ASSAY DEVELOPMENT

BILLERICA, MA

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.

ROLE SUMMARY:

We are looking for an experienced and highly motivated Director, Assay Development to drive continued growth and expansion of our portfolio of ultrasensitive Simoa immunoassays. 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. It is important that the candidate leads teams effectively, influences cross-functionally, and possesses top-tier technical

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:

• BS/BA degree + 15 years of related experience, or MS/MA degree + 13 years of related experience, or PhD + 10 years of life science experience
• 10+ years of experience in immunoassay development experience in an industrial setting (e.g., in vitro diagnostic, clinical trials, contract research, or pharmaceutical/biotechnology).
• Experience directly leading immunoassay development projects
• 5+ years of People Management experience

PREFERRED QUALIFICATIONS:

• 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
• Subject matter expertise and thought leadership in the field of protein biomarkers for neurodegeneration, infectious disease, or cancer is strongly preferred.
• 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.

EXPECTATIONS, SKILLS & ABILITIES:

• 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.

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 eligible to be 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

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.

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