Principal Research Associate – Biomarker Immunoassays & QA

Moderna; Norwood (KY); On-site; USD 90,000 - 144,000; Full time

Benefits offered by this job

Competitive healthcare

Holistic well-being resources

Family planning benefits

Generous PTO

Discretionary bonus / equity

Job summary

Moderna is seeking a Principal Research Associate for the Clinical Biomarker Laboratory, focusing on ligand-binding and cell-based assays for biomarker testing across clinical programs. The role involves hands-on assay development, qualification/validation, and regulated data generation in a fully onsite setting.

You will collaborate with biomarker leaders, biostatisticians, and QA partners to ensure high-quality, regulatory-compliant data supporting vaccine development.

Qualifications

• Bachelor’s/Master’s/PhD in Pharmaceutical Sciences or related field with strong quality data analytics background.
• 4–8 years of relevant clinical lab experience in pharma industry or CROs.
• Experience with immunoassays and cell-based assays for biomarker studies in clinical phases.
• Knowledge of bioanalytical method validation and data management systems (LIMS/ELN/LES).
• Familiarity with GLP, CAP/CLIA, and GxP environments is preferred.
• Proficiency in Microsoft Office; statistical analysis knowledge is a plus.
• Strong documentation, communication, and cross-functional collaboration skills.

Responsibilities

• Develop analytical quality data standards per GLP/ICH/GCP in collaboration with CBL leads.
• Oversee data quality metrics and daily QA oversight.
• Evaluate performance and regulatory alignment of assays and data.
• Lead cross-functional initiatives for quality metrics and reporting.
• Coordinate documentation review and corrections across regulated studies.
• Act as Document Coordinator for controlled documents and training.
• Maintain master schedule and SOP updates.
• Lead quality analytics processes and reporting for GxP compliance.
• Support QC review of clinical biomarker data and assay methods.
• Review protocols, reports, and batch records using LIMS/ELN documentation.
• Produce training manuals for staff on best practices.
• Collaborate to evolve the Quality Management System and risk-based solutions.
• Coordinate with internal/external groups to improve data analysis workflows.
• Maintain high efficiency and accuracy in a fast-paced environment.

Skills

Attention to detail

Communication skills

Multi-tasking

Education

Bachelor’s/Master’s/PhD in Pharmaceutical Sciences

Tools

LabVantage LIMS

ELN/LES data systems

Excel

Job description

Moderna is seeking a Principal Research Associate for the Clinical Biomarker Laboratory, focusing on ligand-binding and cell-based assays for biomarker testing across clinical programs. The role involves hands-on assay development, qualification/validation, and regulated data generation in a fully onsite setting.

You will collaborate with biomarker leaders, biostatisticians, and QA partners to ensure high-quality, regulatory-compliant data supporting vaccine development.