Program Manager, Product Development Quanterix
Job Code: PM-100
Quanterix is an exciting early stage company whose mission is to commercialize a game-changing instrument platform with a menu of immunoassay products that combines proprietary single-molecule sensitivity, multiplexing, and full automation. This is an opportunity to become part of a rapidly growing company on a trajectory to have a major impact in life science research and clinical diagnostics. We are seeking a talented and passionate Program Manager, Product Development to join our team and drive development of Quanterix?s portfolio of assay products.
The Program Manager, Product Development will report to the Vice President of Product Development. In this position, the successful candidate will be responsible for leading the Program Management function at Quanterix in support of product robustness and quality for a menu of immunoassay products on an automated instrument system. The main function of the Program Manager will be to plan, track, and insure proper execution of assay development and commercialization activities. The incumbent will also have direct project management responsibilities, and will manage the technical writing, labeling, and document function at Quanterix. This is a highly matrixed position requiring the incumbent to manage multiple priorities and interfaces across different groups and a variety of stakeholders. This position represents an opportunity to have a major impact on the rapid development and growth of the Quanterix assay menu.
Drives the product development program as a leader in the Product Development team. Key lateral interfaces include heads of Immunoassay Research, Immunoassay Development, Manufacturing, and QA.
Provides general oversight of the RUO assay menu program. Looks for and addresses gaps in execution and process. Helps identify and implement high-efficiency processes to meet very aggressive product development timelines.
Provides oversight of design control activities in support of Quanterix Quality System. Includes instrument system reagent and RUO assay product design and development planning and execution. Schedules and manages product design reviews and ensures documentation is sufficient, accurate, and resides in appropriate controlled location within the Document Management System.
Responsible for defining and maintaining the Quanterix document control system and processes.
Proactively identifies potential project risks and develops contingency plans.
Provide technical input in technical meetings; interacts directly with heads of technical groups and individual team members to help ensure seamless execution of program plans.
Monitors progress at project and program level, facilitating technical teams to focus on technical. Brings project manager perspective to RUO assay projects. Tracks progress weekly, schedules meetings, drives development of Product Requirements.
Supports the Quanterix Quality System by contributing to Process and Procedure content.
Brings QA perspective to technical meetings and design reviews.
Manages the Quanterix Technical Writing function, ensuring high quality documents, both internal and customer-facing.
Advanced degree in Chemistry, Engineering, Biological / Life Science or related field. 7-10 years project / program management / leadership experience in the medical device industry.
Strong leadership and negotiation skills.
Good understanding of QSR and ISO regulatory requirements for In-Vitro Diagnostic products and Good Lab Practice.
Excellent communication skills, ability to understand and communicate technical scientific information to a wide range of audiences.
Experience working with x-functional teams and coordinating efforts among in-house teams.
Proficiency with MS Project, Excel, PowerPoint, and MSWord programs essential.
Team player with confidence, unquestioned character, and absolute integrity.
Ability to thrive and flourish in an entrepreneurial early stage company environment that requires ?hands-on? implementation, optimal use of limited resources and an ability to work closely with others in a small team setting.
Ability to work in a fast-paced and changing environment; flexible and quickly adaptable to changing priorities.
Strong interpersonal skills; ability to establish rapport and productive relationships. Ability to engender the trust and confidence of internal constituency (employees, management team) and external partners.
Sound judgment; strong analytical and business skills.
Strong time management and organizational skills coupled with a sense of urgency and strong work ethic.
Creative, strategic, flexible and able to think ?out of the box.?
Must be a highly motivated self-starter, show initiative/ independence, and be driven to make an important business contribution.
Consistently displays a positive, patient attitude and extends respect and courtesy toward supervisors and peers.
Quanterix Corporation is a privately held, dynamic and growing company located in Lexington, Massachusetts. We are building a team of best-in-class scientists, engineers and business professionals that thrive in a collaborative high-energy entrepreneurial environment. We believe that the commercialization of an enabling technology with the potential to revolutionize life science research and clinical diagnostics will require the very best people working together and exchanging ideas while sharing a commitment to innovation.
Quanterix is an Equal Opportunity Employer that offers a competitive and comprehensive employee benefits package, including health, dental, life insurance, a flexible spending plan, paid vacation, stock options and a 401(k) investment plan.
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