Scientist, Product Transfer

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 motivated Scientist in Billerica, MA to join our Product Transfer team. This individual will provide technical and operational support for development, technology transfer, and sustaining of our ultrasensitive immunoassay product line, including direct custom and small scale production support.

What You’ll Do:

• Lead immunoassay transfer projects, from concept through to commercialization in a quality compliant environment. Adhere to design & development processes and documentation practices that meet the requirements of the organization.
• Design and execute hands-on analyses of biological samples on multiple immunoassay platforms.
• Analyze and summarize complex datasets under tight deadlines.
• Troubleshoot and optimize assay design and protocols for reagent production and Quality Control.
• Develop and document product requirements, work instructions and assay validation reports.
• Represent Product Transfer on cross-functional program teams.
• Proactively identify opportunities for product and process improvement by evaluating potential process changes in manufacturing and quality control.
• Implement process improvements in manufacturing and quality control, optimizing processes to improve repeatability and reproducibility.
• Apply technical knowledge of immunoassays, laboratory skills, creative thinking, and aptitude towards instrumentation to troubleshoot assay issues in Development, Pilot and Manufacturing.
• Collaborate with Manufacturing, Assay Development, Engineering, Technical Support, and Quality Control groups to support resolution of complex issues.
• Support document updates, revisions, change controls, CAPAs, SOPs, deviations, etc.
• Support Manufacturing, Quality Control and Assay Development by shadowing the process and providing beneficial feedback and knowledge on the process.
• Support and help drive implementation of best practices and process improvements.

What We’ll Expect From You:

• Experience in immunoassay product development strongly desired, including reagent development and optimization, assay protocol optimization, migration of manual assays to automated instrumentation, specifications development, statistical methods, verification and validation protocol writing and execution, conformance with design control regulations.
• Experience with development and/or validation of assay products is a plus.
• Knowledge of chemistry and raw materials a plus.
• Must be detail oriented with excellent organizational, record keeping, and communication skills.
• Demonstrated ability to support multiple projects under aggressive timelines.
• Self-motivated with a strong work ethic.
• Ability to collaborate cross-functionally.
• Must be proactive and ensure all work meets company compliance standards.
• Document all activities in accordance good documentation practices.
• Succinct and clear written and verbal communication capabilities.
• Proficiency with software for statistical analysis and data visualization.
• Direct experience bringing commercial life science products to market.

Minimum Experience and Education

• D. in Biology, Biochemistry, Immunology or related field; or BS/MS with substantial relevant experience.
• 4 years of experience developing immunoassays preferred.
• Experience with preparation and handling of complex and sensitive bio-reagents.

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 https://www.quanterix.com.

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.

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