IVD Process Engineer

Role Summary

We are looking for an experienced and motivated candidate to join our Process Development team. In this critical role, this individual will drive the development and deployment of our IVD reagent supply and manufacturing processes, from the lab bench through to production scale. You will design and execute experiments and drive innovations to continuously advance process characterization and scale up methodology in an FDA-regulated environment. You will identify technical requirements in our products, define appropriate methods, and work with internal and external stakeholders to enable a sustainable reagent operations process.

What You’ll Do

• Develop reagent processes and collaborate with Research, Technology and Reagent R&D on IVD and RUO product development.
• Define requirements and documenting process for IVD and RUO products.
• Deploy analytical test systems in collaboration with Research, Technology and Reagent R&D, Technical Operations and Quality to characterize and qualify reagent components.
• Implement reagent product manufacturing processes, including formulation, filling/finishing, and packaging processes for both IVD and RUO products.
• Continuously improve the reagent manufacturing including supplier technical support, process development and implementation. Includes working with suppliers on consumables.
• Facilitate root cause analysis and ideation of the improvement opportunities from the metric discussions.

BASIC QUALIFICATIONS

• BS in molecular biology, biochemistry, chemistry, or engineering. 15+ years of experience.
• MS in chemistry/biology technology disciplines as above, with 12+ years of experience.
• PhD in chemistry/biology technology disciplines as above, with 8+ years of experience.
• 5+ years of experience in product and process development.

PREFERRED QUALIFICATIONS

• Experience in IVD and/or RUO product and process development
• Experience developing reagent manufacturing processes in a regulated environment
• Knowledge of reagent formulation, fill/finish, and packaging processes
• Experience with process characterization, qualification, and scale-up
• Familiarity with analytical test methods for reagent/component evaluation
• Experience supporting manufacturing operations and process transfer
• Knowledge of biomolecule diagnostics or related assay technologies
• Experience partnering cross-functionally with R&D, Operations, Quality, and suppliers
• Strong root cause analysis and continuous improvement skills

Expectations, Competencies, Skills & Abilities

• IVD/RUO reagent process development
• Process characterization and analytical methods
• Reagent formulation and scale-up
• FDA-regulated product/process development
• Technical problem solving and troubleshooting
• Root cause analysis and process optimization
• Manufacturing process transfer and implementation
• Biomolecule diagnostic systems knowledge
• Demonstrated technical expertise as well as management experience.
• Significant experience in product and process development.
• Experience in biomolecule diagnostics is ideal.
• Both small/large-scale project/process experience and manufacturing operations experience.
• Individuals applying for this position must be self-starters, flexible in changing direction and methods and thrive in a fast-paced environment

Workplace Location

Billerica, MA

Travel

10%

Pay Range

$150,000 - $180,000 per year

Apply for this Position