MS-100. Manufacturing Supervisor Quanterix
Job Code: MS-100
Quanterix is an exciting early-stage commercial company whose mission is to develop a game-changing platform that combines proprietary single-molecule sensitivity, multiplexing and full automation with its revolutionary Single Molecule Array (Simoa) technology. Located in Lexington, MA, the company has launched an instrument for the life sciences and diagnostics industries. With unprecedented sensitivity, multiplex capabilities, and full automation, Simoa offers significant benefits for both research and clinical testing applications. To continue our solid growth, we are seeking a talented and highly motivated Manufacturing Supervisor to join our growing organization.
This position is responsible for all Reagent Formulation, Filling and Kitting functions for an early stage diagnostics manufacturing company with a highly complex technology and extensive product portfolio. These functions include antibody purification and conjugation procedures, buffer formulation, bulk reagent formulation, vial and bottle fill/cap/label and final kitting operations. The processes and documentation required to support these functions will be improved and proceduralized as part of this role. With platform commercialization, this Manufacturing position will be responsible for the day-to-day operations, in a highly cross-functional environment, that will result in high quality product, high levels of customer service and compliance. The position will be responsible for scheduling of all workcenter operations and training of employees.
The ideal candidate will be an innovative leader with immunoassay product manufacturing operations. Experience with Lean Manufacturing principles in addition to a depth of experience in a low unit volume and high product mix environment is required.
Specific responsibilities for this role include
Assess manufacturing capacity requirements on an ongoing basis, resource people and equipment as needed
Manage daily production schedule
Create and maintain process and equipment documentation
Develop ERP system expertise
Creation and maintenance of BOMs/routings
Shop floor control
Interact with Assay Develop and Program management on New Product Introductions, participate on project teams and in product design and technical reviews
Manage cost center and capital budgets, including inventory control and cycle count
Hire and train appropriately experienced manufacturing personnel
Bachelor?s Degree in Biology, Chemistry or related Life Sciences
7-10+ years of experience in medical device industry
3-5+ years of experience with immunoassay manufacturing formulation operations
Experience with GMP- and ISO-certified manufacturing operations required
Experience with Lean Manufacturing and Continuous Improvement required
Experience with chromatography and protein conjugations required
You need excellent organizational, record keeping and communication skills ? Demonstrated creative critical thinker ? Demonstrated ability to work well within cross-functional teams as a team player ? Possess an ability to learn and master complicated concepts quickly and comfortably ? A strong work ethic, the ability to generate high quality data under tight deadlines, and a collaborative, proactive attitude.
You will be working in a fast-paced environment, on multiple projects, with some of the brightest minds in the business. You will have an opportunity to develop breakthrough products and impact the successful development of a new disruptive technology in its early stages. You will be a part of a rapidly growing company on a trajectory to have a major impact in the life science research and clinical diagnostics arenas.
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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