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Director, Clinical Testing Operations

Company: Quanterix
Location: Billerica
Posted on: August 7, 2022

Job Description:

Job Description Quanterix is a company 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. In our focused therapeutic areas, our revolutionary technology, Simoa--, is helping researchers advance the science of precision health. Simoa-- is changing the way in which the biology of health and disease is studied by giving researchers the ability to closely examine critical biomarkers in most therapeutic areas including neurology, infectious disease, oncology, inflammation, and cardiology. To continue our extraordinary growth, we are hiring a Director, Clinical Testing Operations for our Laboratory Services group, in Billerica, MA . The Director, Clinical Testing Operations will function in the role of technical supervisor in a high-complexity CLIA laboratory. This person will be a technical leader responsible for the implementation and ongoing performance of clinical tests performed on Quanterix's ultra-sensitive technology. Additionally, they will manage the day-to-day clinical testing operations, including planning of tests, allocating resources, supporting troubleshooting, reporting data and supporting customer interactions. What you will do Collaborate with the CLIA Laboratory Director, Quality Assurance staff and Assay Development teams to design and execute validation plans for new clinical tests based on Quanterix's ultra-sensitive technology. Maintain a menu of clinical tests, including overseeing proficiency testing, training of staff, maintenance of equipment, etc. Manage daily clinical testing operations. Monitor and adjust workflow and staffing to maximize the productivity of the lab. Provide coaching, goal setting, training and performance development for staff. Collaborate with leadership to develop annual plans and new programs to improve efficiency, quality, compliance, service and financial outcomes for the laboratory. Implementation and maintenance of standard laboratory procedures. Documentation and maintenance of staff competency. Assist with recruitment, and onboarding of new staff. Train laboratory staff on procedures, good laboratory practice, and technical methods. Assist with the management of the laboratory budget. What We'll Expect From You: PhD. degree in a Biology, Chemistry, Biochemistry or related life sciences field 5 years of CLIA laboratory services leadership and team management Experience in the validation and implementation of new tests and new technologies in a clinical laboratory; experience with Laboratory Developed Tests (LDTs) is a plus Knowledge of GCLP, CLIA and ISO15189 compliance, quality, and data security requirements for studies analyzing patient samples 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: We have a free, state-of-the-art onsite fitness center for all employees. To keep you fueled up, we provide onsite employees free bagels every Monday morning, and free snacks and drinks every day Quanterix hosts Virtual Bingo nights with all employees when we can see families, pets, and win amazing prizes. Unwind on Tuesdays and Thursdays with a virtual yoga session. In addition to competitive compensation and a 401k plan with an employer match, we offer competitive health, dental, and vision benefits for employees and their dependents. We offer a Flexible Spending Account (FSA), Life, Disability, and Accidental Death & Dismemberment Insurances, and Mental Health Care, we offer generous Maternity & Paternity leave, Family Medical Leave, Fertility Assistance, Dependent Care, Military Leave and Vacation Carryover. All employees are awarded Equity, an Employee Stock Purchase Plan, a Performance Bonus, and 1:1 Financial Counseling/Planning. We also offer Tuition Assistance. Our Culture: Quanterix is committed to a Diverse and Inclusive workplace. We have a Diversity Program with Executive Sponsorship. Our core values are Accountability, Teamwork, Trust, and Transparency OR ATT2. Meet some of our team HERE. 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-MM1

Keywords: Quanterix, Billerica , Director, Clinical Testing Operations, Executive , Billerica, Massachusetts

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