Senior Biomarker Scientist, Immunoassay & Cell-Based Lab

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

Benefits offered by this job

Competitive healthcare

Well-being resources

Generous paid time off

Job summary

Moderna is seeking a Principal Research Associate for the Clinical Biomarker Laboratory (CBL) Immunoassay and Cell Based Assay group. The role focuses on developing and implementing ligand-binding and cell-based assays for biomarker testing across infectious disease, oncology, and autoimmune programs.

The successful candidate will perform assay development, qualification/validation, clinical sample testing, and data analysis in a regulated clinical lab environment, partnering with QA,

Qualifications

• Bachelor's/Master's/PhD in Pharmaceutical Sciences or related field with strong quality data analytics background.
• Experience in clinical laboratory settings and GLP/GxP principles is preferred.
• Knowledge of biomarker and immunogenicity assay techniques is required.

Responsibilities

• Develop analytical quality data standards in line with GLP/ICH/GCP across clinical studies.
• Gather quality data to establish metrics and oversee Data Quality procedures.
• Lead initiatives for quality metrics and reporting with cross-functional teams.
• Collaborate with study personnel for document review and QA audits.
• Coordinate document control and version tracking; train staff on new SOPs.
• Support development or revisions of SOPs and master schedules.
• Perform data analysis to improve GxP compliance and risk management.
• Assist QC review/approval of clinical data from biomarker assays.

Skills

Immunoassays

Cell-based assays

Data analytics

GxP compliance

Quality data management

Education

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

Tools

LabVantage LIMS

ELN/LES systems

CDISC

R/Statistical analysis

Excel

Job description

Moderna is seeking a Principal Research Associate for the Clinical Biomarker Laboratory (CBL) Immunoassay and Cell Based Assay group. The role focuses on developing and implementing ligand-binding and cell-based assays for biomarker testing across infectious disease, oncology, and autoimmune programs.

The successful candidate will perform assay development, qualification/validation, clinical sample testing, and data analysis in a regulated clinical lab environment, partnering with QA,