We are seeking a talented and highly motivated Senior Scientist who thrives in a problem-solving oriented position to join our Process Excellence Group. Key responsibilities will include identifying opportunities to continuously enhance customer experience with assay performance via improvements to our development and manufacturing processes.
- Apply detailed technical knowledge of immunoassays, laboratory skills, aptitude towards instrumentation and creative thinking to determine root cause of failing processes, materials or components to develop recommendations on how to best correct issues.
- Work closely with Technical Support to resolve challenging customer issues with Quanterix assay kits that warrant in-depth experimental investigation and root cause analysis.
- As appropriate, enlist support from the Assay Development, Engineering, Manufacturing and QC groups and lead cross-functional efforts to support the resolution of more complex issues.
- Support the assay kit manufacturing group by recommending solutions to issues limiting manufacturing process yield and scalability for both kits and kit components.
- Work closely with vendors on raw material quality and supply issues that negatively impact assay performance.
- Use technical know-how and experience to collaborate with assay kit manufacturing and assay development groups to make improvements to the development of future assays
- Maintain a data base of status and progression of all pending, active, and closed issues to enable robust reporting
Skill and Knowledge Requirements:
- Strong technical experience and know-how in immunoassay product design and/or manufacturing is essential, including: reagent development and optimization, assay protocol optimization, migration of manual assays to automated instrumentation, specifications development, statistical methods, verification and validation protocol writing and execution, conformance with design control regulations
- Detailed understanding of key success criteria for successful development and manufacture of immunoassay products
- Expertise with data analysis and visualization, Design of Experiments and statistical analysis tools highly desirable
- Formal training in and/or exposure to Lean/Six Sigma principles desired, but not required
- Experience with materials and process development a plus
- Must be detail oriented with excellent organizational, record keeping, and communication skills
- Comfortable in fast paced environment with rapidly changing priorities between active troubleshooting activities and strategic initiatives
- Strong work ethic
- Ability to comfortably collaborate cross-functionally, and lead through influence
- Maintain a positive attitude and a proactive approach
Minimum Experience and Education:
- Advanced degree (MS or PhD preferred) in Biology, Biochemistry or related Life Science discipline
- 5-7 years relevant experience in life science, biotech or IVD markets
- 2-5 years of industry experience in immunoassay development.