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 highly motivated Project Coordinator in Billerica, MA to join our Assay Development team. The Project Coordinator will manage the cross-functional development, transfer and commercialization of immunoassay products, process improvements, as well and sustaining operations program to support the strategic priorities. The position will be responsible for ensuring that established scope, schedule, and resources for projects are implemented. Responsibilities extend to performing the necessary tasks to enter a project/product into Design Control and supporting Design Validation and Design Transfer.
What You'll Do:
Drive projects through the assay development lifecycle, working closely with the Program Governance team.Lead the Core Team to ensure tight coordination of cross-functional deliverables and providing guidance on conformance to established Design Control procedures and ensuring successful execution of the program.Lead assay design transfer from R&D to Product Transfer and Manufacturing Stages.Drive concise and clear program updates to Governance Team ensuring delivery of accurate and timely updates, and appropriate escalation and remediation of risks.Document program scope, constraints and assumptions in detailed integrated program/project plans including schedule and resource needs in accordance with the strategic goals and priorities of the organization as per the design of the program governance.Establish and maintain a project risk registry and drive execution against risk mitigation plans as required to achieve project objectives.Proactively implement and manage changes to the integrated project plans to ensure goals are achieved including customer satisfaction, safety, and quality, in a manner that is consistent with Quanterix company values.Ensure complete and robust translation of marketing requirements through to validated product performance.Ensure project execution to appropriate quality standards of practice consistent with our Quality Management System.Hold team members accountable for areas of responsibility to the program team and ensure support and focus on objectives.Assist in development of project management best practices, techniques, and disciplines.Project Coordinator responsibilities extend to successfully managing and leading multiple high visibility, time sensitive and complex projects in parallel.
What We'll Expect From You:
2+ years of Project Management experience.2+ years of experience in Immunoassay Development, Biotechnology, Medical Device, or Life Science industry is highly encouraged.Technical degree in Science or Engineering fields (preferably in Biochemistry/ Chemistry or SW/ME/EE/biomedical Engineer disciplines) is preferred. Experience with understanding and drafting technical documents is a plus.Experience in leading cross-disciplinary product development teams: R&D, Marketing, Quality, Field Service, Operations, etc. is highly desired.Experience transferring products through phase gated process from R&D through manufacturing preferred. Exposure to diagnostic (IVD) device development is a plus.Strong preference for experience with immunoassay product development program.Experience in 3rd party/vendor relationship management.Expertise in Microsoft applications including Word, Excel, and PowerPoint; expertise in one or more Project Management software such as Microsoft Project; JIRA, Confluence or SmartSheets;Experience working in ISO 13485 or cGXP environment is a plus.Very limited travel; < 5% of time.PMP certification is plus but real world project management experience is preferred.
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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