Senior, Process Development Engineer

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Quanterix is a company 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. In our focused therapeutic areas, our revolutionary technology, Simoa®, is helping researchers advance the science of precision health. Simoa® is changing the way in which the biology of health and disease is studied by giving researchers the ability to closely examine critical biomarkers in most therapeutic areas including neurology, infectious disease, oncology, inflammation, and cardiology. To continue our extraordinary growth, we are hiring a Sr Process Development Engineer located in Billerica, MA. 

We are looking for an experienced and motivated candidate to join our Process Excellence team. As the expert in process development, this person will provide technical leadership for manufacturing process Improvement, process scale up, and manufacturing technical support. This individual should be a strong team player with well-developed communication and technical presentation skills. This person will partner cross-functionally with Manufacturing, Process Development, R&D, Engineering, and Finance to accomplish company and project goals.

What You’ll Do:

  • Apply technical knowledge of immunoassays, laboratory skills, aptitude towards instrumentation, and creative process development and trouble shooting skills to:
    • Establish reagent manufacturing process requirements to meet product specifications
    • Lead the development, optimization, and scale-up of reagent manufacturing processes
    • Provide technical oversight of development and pilot plant builds
    • Solve challenging, interdisciplinary technical problems at the interface of biology, chemistry, engineering, and materials science.
    • Drive implementation of process improvements into manufacturing to meet product launch and business goals
    • Define, source, install, and qualify manufacturing equipment in support of manufacturing process and product volume requirements.
    • Work with external suppliers to define raw material and equipment specifications to optimize manufacturing and product performance.
    • Develop test methods to assess raw material quality
    • Define technical and operational process requirements. Translate technical requirements to define and document manufacturing specifications and procedures
    • Design, develop and execute experiments independently to justify technical decisions.
  • Minimal travel required.

Qualifications:

  • Work experience in biotech, life sciences, or pharmaceutical industries preferred.
  • Hands-on experience with molecular biology or microbiology techniques
  • Work experience in reagent/consumables production and product development
  • Experience with apply statistical tools including DOE, Gage R&R, process capability, and Statistical Process Control
  • Demonstrated ability to solve challenging, interdisciplinary technical challenges..
  • Strong interdepartmental communication skills
  • Intermediate software programming, scripting, and lab automation skills is a plus.
  • Knowledgeable of ISO 13485, ISO 14971, 21 CFR 820 / 11

Education/Experience:

  • S./M.S./PhD in Chemical Engineering, Biochemical Engineering, Bioengineering, Biotechnical Engineering, or Biology with 8+ years of relevant experience in a technical manufacturing support and/or process development role
  • Lean Six Sigma Green Belt or Black Belt certification 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: We have a free, state-of-the-art onsite fitness center for all employees. To keep you fueled up, we provide onsite employees free bagels every Monday morning, and free snacks and drinks every day! Quanterix hosts Virtual Bingo nights with all employees where we can see families, pets, and win amazing prizes. In addition to competitive compensation and a 401k plan with an employer match, we offer competitive health, dental, and vision benefits for employees and their dependents. We offer a Flexible Spending Account (FSA), Life, Disability, and Accidental Death & Dismemberment Insurances, and Mental Health Care, we offer generous Maternity & Paternity leave, Family Medical Leave, Fertility Assistance, Dependent Care, Military Leave and Vacation Carryover. All employees are awarded Equity, an Employee Stock Purchase Plan, a Performance Bonus, and 1:1 Financial Counseling/Planning. We also offer Tuition Assistance.

 

Our Culture: Quanterix is committed to a Diverse and Inclusive workplace. We have a Diversity Program with Executive Sponsorship. Our core values are Accountability, Teamwork, Trust, and Transparency or ATT2. Meet some of our team HERE. 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.