Senior Scientist, Diagnostics

Quanterix
tuition assistance, 401(k)
United States, Massachusetts, Billerica
Jan 23, 2025
SENIOR SCIENTIST, DIAGNOSTICS Billerica, MA 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. We are looking for an experienced and highly motivated Senior Scientist, Diagnostics located in Billerica, MA to join our Diagnostics Team. The suitable candidate should have prior experience in immunoassay development with a strong desire to validate and troubleshoot ultrasensitive immunoassays targeting emerging biomarkers for neurodegenerative disease, immunology, and oncology. The primary focus of this role will be on the verification and validation of immunoassays for regulatory submission, ensuring compliance with regulatory guidelines (for example CLSI guideline). The successful candidate will be responsible for performing the necessary tasks to complete Design Control projects, contributing to the development of high-quality LDT and IVD products. What You'll Do: Verification and Validation: Design, plan, and execute verification and validation studies for Simoa based immunoassays, ensuring adherence to FDA or CLSI guidelines.Develop and optimize assay protocols to meet performance specifications and regulatory requirements. Conduct statistical analysis of assay performance data to ensure robustness, accuracy, precision, specificity, and sensitivity. Responsible for analyzing data, writing comprehensive reports, participate in development of documentation, templates and other process improvements Regulatory Compliance: Prepare and review documentation for regulatory submissions, including verification and validation reports, standard operating procedures (SOPs), and technical summaries. Ensure activities comply with relevant regulatory standards and guidelines, including FDA or CLSI. Design Control: Participate in Design Control projects, including risk management, design input and output documentation, design verification and validation, and design transfer. Collaborate with cross-functional teams to ensure timely and accurate completion of Design Control deliverables. Quality Assurance/ Regulatory: Work closely with Quality Assurance and Regulatory to ensure all verification and validation activities meet internal and external quality standards. Support the development and maintenance of quality systems and processes related to assay development and validation. Initiate, investigate & close quality systems (deviation, NCMR, CAPA, change control) Technical Expertise: Serves as the subject matter expert member for technical core team, risk management process, in investigations and resolutions of experimental issues Stay current with advances in immunoassay technologies and regulatory requirements. Provide technical guidance and training to junior team members and other departments as needed. What We'll Expect From You: Basic Qualifications: Masters in Biochemistry, Molecular Biology or Immunology 7+ years of experience developing immunoassays Experience with regulatory submissions Preferred Qualifications: PhD and 4+ years of experience developing immunoassays in regulated environment preferred Experience developing immunoassays preferably for IVD submission (21 CFR 820). Familiarity with other regulatory guidelines (e.g., ISO 13485, ICH). Experience supporting risk management ISO 14971. Proficiency in designing and conducting verification and validation studies for immunoassays. Experience with new product launch: design verification and clinical validation studies to support new product launches. Familiarity with FDA and CLSI guidelines Excellent documentation and technical writing skills, with experience in preparing regulatory submission documents. Experience in data analysis software (e.g., JMP, Minitab) Strong problem-solving skills and attention to detail. Ability to work collaboratively in a cross-functional team environment. Previous experience in a regulated industry, such as diagnostics or pharmaceuticals. Experience with Design Control processes and project management. Familiar with electronic document management systems, i.e. MasterControl, Arena Expectations, Skills & Abilities: This position is on-site 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 CUA-certified Accelerator laboratory have supported research that advances disease understanding and management in neurology, oncology, immunology, cardiology, and infectious disease. Our Values 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. #LI-Onsite #LI-JC2