Senior Quality Scientist – Immunoassay & Process Lead

Meso Scale Diagnostics LLC; Rockville (MD); On-site; USD 88,000 - 134,000; Full time

Job summary

Meso Scale Diagnostics LLC in Rockville, MD, seeks a Senior Quality Scientist to independently manage testing priorities, design experiments, and mentor analysts on troubleshooting and experimental design for protein-based immunoassays.

You will lead CAPA and MRB activities, review data, ensure ISO/GMP compliance, and support product release. The role requires strong leadership, the ability to manage multiple projects, and a proactive approach to quality improvement.

Qualifications

• Bachelor's degree in life sciences or related field required; PhD preferred.
• Minimum of 6 years of industrial reagent, product, or assay development experience.
• BSL-2 techniques experience highly preferred.
• Experience with ISO/GMP quality systems preferred.

Responsibilities

• Troubleshoot non-conforming products and manage multiple high-impact projects to improve product and process quality.
• Direct testing, analyze data, review and approve results and conclusions of others in the group.
• Approve CAPA documents, such as NCMRs and DEVs; approve MRB results.
• Review and approve presentations of junior level analysts and scientists in the group.
• Lead MRB meetings and present to cross-functional and/or senior management teams.
• Develop, revise, approve and implement SOPs/Test Records/product specification documents.

Skills

Leadership

Experiment design

Troubleshooting

Data analysis

Protein immunoassays

Molecular biology basics

Communication skills

MS Office

Team coaching

Education

Bachelor's degree in life sciences/related field

PhD preferred

Tools

SharePoint

Excel

Quality document systems

Job description

Meso Scale Diagnostics LLC in Rockville, MD, seeks a Senior Quality Scientist to independently manage testing priorities, design experiments, and mentor analysts on troubleshooting and experimental design for protein-based immunoassays.

You will lead CAPA and MRB activities, review data, ensure ISO/GMP compliance, and support product release. The role requires strong leadership, the ability to manage multiple projects, and a proactive approach to quality improvement.