DIRECTOR OF PRODUCT TRANSFER

Company: DaVita Inc.
Location: Billerica
Posted on: October 26, 2024

Job Description:

Director Product TransferBillerica, MA
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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 the 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, to form a collaborative ecosystem, united through the common goal of advancing the science of precision health.ROLE SUMMARY:In this role, you will lead a team responsible for the transfer of products from R&D development into Operations as well as lead the team responsible for highly technical processes, pre-commercial products, or products currently on the market in manufacturing. The role contributes to continuous improvement initiatives for Quanterix's assay platforms, custom product programs for strategic partners, and the development of future IVD products.WHAT YOU'LL DO:

• Lead a team of 12+ professionals/scientists responsible for developing and implementing operation requirements for design transfer of assay consumable products from R&D through manufacturing to assure that all aspects of design for quality and manufacturability are utilized for robust design development, transfer, and ultimately scale up in manufacturing.
• Partner with functions and groups in prioritizing areas of focus to support the company's long-term strategy, present, and near future objectives.
• Collaborate/Co-develop with R&D and product management to define product and component requirements and specifications that will lead to successful transfer to manufacturing and achieve the target yield and cost of goods.
• Willing and able to be hands-on to execute all processes in the lab to support the team and ensure product quality is achieved.
• Provide individual or team technical knowledge to other areas of the company when needed.
• Serve as an advocate and role model for integrating change into the organization as well as serve as a departmental role model of professional behavior and presence.
• The candidate must be adept at bringing R&D, Manufacturing, and Quality Assurance teams to consensus to assure appropriate test method validations and product specifications are developed and implemented, balancing risk, compliance, and business objectives.
• Partner with Sustaining Engineering members for developing or improving the manufacturing process.
• Establish manufacturing processes and expectations, with support from R&D to establish successful product transfers within the Manufacturing Department.
• Coach and train Manufacturing to establish the flow and process of new materials and products as they transfer from R&D development.
• Responsible for the technical manufacture of highly technical or difficult to manufacture product lines.
• Accountable for complete documentation that supports process and production procedures.
• Support the company's diagnostics roadmap by creating processes and systems that will support verification and validation products under design control and manufacturing under GMP.
• Build and lead a high-performing team.
• Manage budgets and operations related to product transfer activities.
• Other duties as assigned.BASIC QUALIFICATIONS:
• Ph.D. in Biology, Biochemistry, Molecular Biology, or Chemistry.
• 10+ years working in industry and/or academia in a laboratory or manufacturing setting.
• Direct experience leading immunoassay industry manufacturing.PREFERRED QUALIFICATIONS:
• Extensive knowledge of best practice/cutting edge manufacturing of high and low volume immunoassays.
• Demonstrated history of organizing and commercializing consumable assay products, including submissions to regulatory agencies.EXPECTATIONS, COMPETENCIES, SKILLS & ABILITIES:
• Management experience, including the ability to recruit, lead and develop a multidisciplinary team.
• Excellent verbal and written communication and interpersonal skills to work across functions and within external collaborations.
• Passion for delivering high-quality manufacturable products to Manufacturing.
• Onsite position.
• Travel 5%.
• Must be able to lift 25 pounds.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 CLIA-certified Accelerator laboratory have supported research that advances disease understanding and management in neurology, oncology, immunology, cardiology, and infectious disease.Our Commitment to Employees: At Quanterix, our values are based on: Team, Innovation, Customer, and Owner. 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
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Keywords: DaVita Inc., Lynn , DIRECTOR OF PRODUCT TRANSFER, Executive , Billerica, Massachusetts