Quanterix is hiring a

Director, Process Excellence

Billerica, United States

To continue our solid growth, we are seeking an experience and motivated Director of Process Engineering to join our growing organization.  The individual should be self-motivated, creative, and proactive, able to work successfully in a fast-paced environment including multiple platforms and architectures, diverse technologies, and lab environments. The individual will work closely with Manufacturing, R&D, product support engineers, scientists, and other stakeholders.

The ideal candidate will be an innovative leader with Process Engineering and immunoassay product design experience that will define and implement process characterization and manufacturing equipment selection approaches and drive pilot and scale-up efforts  in order to maintain efficiency, reduce cost, improve production success rate and quality of output, improve sustainability, and maximize profitability.

Key Responsibilities:

  • Deploy aligned Operational Excellence (OE) methodologies and drive Process Excellence metrics to improve efficiencies, manage cost of goods, and overall product quality of deliverables.
  • Oversee the activities of and maintain an effective Assay Technical Services group (ATS) that drives effective troubleshooting and root cause analysis and enables continuous improvement of launched assays
  • Oversee the activities of and maintain an effective Pilot Plant group, ensuring collaborative Interactions with Assay Develop and Program Management on New Product Introductions
  • Assess manufacturing capacity requirements and design and implement manufacturing equipment and processes to meet customer demand and internal revenue targets
  • Manage projects related to implementation of larger scale equipment and processes into manufacturing
  • Collaborate in the creation and development of process documentation and operating instructions were needed
  • Manage cost center operational and capital expense budgets and coordinate planning for future year budgets
  • Recruitment, training, performance management, and professional development of manufacturing personnel

 

Skill and Knowledge Requirements:

  • 5+ years of proven work experience in the Diagnostic/Biotech industry; experience with protein conjugations and chromatography in immunoassay manufacturing preferred
  • 5+ years of experience leading and managing high performance teams of engineers and technical staff
  • Experience working within ISO-certified operations required
  • Experience with stage gate Product Development Process (PDP) required
  • Experience with Lean Manufacturing and Continuous Improvement preferred
  • Demonstrated analytical and creative thinker with interpersonal skills
  • Demonstrated ability to work well within cross-functional teams as a team player
  • Excellent collaboration capabilities, with the ability to influence laterally and upwardly

 

Minimum Experience and Education:

  • Bachelor’s Degree required in Science, Engineering or equivalent
  • 10+ years of experience in medical device or life science/research tools industry

 

Quanterix is a company that is digitizing biomarker analysis with the goal of advancing the science of precision health. The company’s digital health solution, Simoa, has the potential to change the way in which healthcare is provided today by giving researchers the ability to closely examine the continuum from health to disease. 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, including oncology, neurology, cardiology, inflammation, and infectious disease. The company was established in 2007 and is in Billerica, Massachusetts. For additional Information, please visit https://www.quanterix.com.

 

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.