Senior Reagent Process Engineer - IVD RUO Manufacturing

Quanterix; Billerica (MA); Hybrid; USD 110,000 - 170,000; Full time

Benefits offered by this job

401k with employer match

Health, dental, and vision benefits

Unlimited vacation policy for exempt

Tuition Assistance

Equity / Employee stock purchase plan

Onsite fitness center

Free snacks and drinks

Job summary

Quanterix in Billerica, MA, is seeking a Sr. Process Engineer to join the Process Development team.

You will drive development and deployment of IVD reagent supply and manufacturing processes from lab bench to production scale, designing experiments and advancing process characterization in an FDA-regulated environment. You will collaborate with Research, Technology and Reagent R&D, Technical Operations and Quality to enable a sustainable reagent operations process and to implement manufacturing

Qualifications

• BS in a related discipline with 6+ years in product and process development; MS with 5+ years; or PhD with 4+ years.

Responsibilities

• Develop reagent processes and collaborate with R&D on IVD/RUO product development.
• Write documentation for IVD and RUO products and processes.
• Deploy analytical test systems to characterize and qualify reagent components.
• Implement reagent manufacturing processes including formulation, filling/finishing, and packaging for both IVD and RUO products.
• Continuously improve reagent manufacturing with supplier technical support and process implementation.
• Facilitate root cause analysis and ideation from metric discussions.

Skills

Process development

Regulated environment experience

Cross-functional collaboration

Documentation discipline

Education

BS in molecular biology, biochemistry, chemistry, engineering, or related discipline

Tools

Analytical testing instruments

Job description

Quanterix in Billerica, MA, is seeking a Sr. Process Engineer to join the Process Development team.

You will drive development and deployment of IVD reagent supply and manufacturing processes from lab bench to production scale, designing experiments and advancing process characterization in an FDA-regulated environment. You will collaborate with Research, Technology and Reagent R&D, Technical Operations and Quality to enable a sustainable reagent operations process and to implement manufacturing