Principal Research Associate, Clinical Biomarker Laboratory

The Role

Moderna is seeking an experienced and highly motivated Principal Research Associate to join the Clinical Biomarker Laboratory (CBL) Immunoassay and Cell Based Assay group. This laboratory-based role will primarily support the development, qualification, validation, and clinical implementation of ligand-binding assays (LBAs) and cell-based assay for biomarker and immunogenicity testing across Moderna's infectious disease, oncology, and autoimmune disease clinical programs.

The successful candidate will have hands‑on experience developing and executing on cell‑based assays and Immuno‑assays. The individual will independently perform assay development and optimization experiments, qualification/ validation experiments, clinical sample testing, data analysis, and documentation in a regulated clinical laboratory environment.

Experience with virus neutralization or functional antibody assays, including cell culture‑based neutralization assays and hem agglutination inhibition (HAI) assays will provide opportunities to support broader CBL immunogenicity assay activities.

The Principal Research Associate will work closely with the clinical Biomarker Laboratory Lead, biostatisticians, Quality/ Compliance partners, and other cross‑functional stakeholders to deliver high‑quality, traceable, and regulatory‑compliant bioanalytical data supporting Vaccine clinical development programs.

• Develop analytical quality data standards related to GLP/ ICH/ GCP in accordance with existing SOPs across clinical studies and in collaboration with Laboratory Operations lead and scientific leaders at CBL.
• Responsible for gathering Quality data required to establish metrics and generate insights and daily oversight of the Data Quality procedures in place.
• Evaluate performance, risks, and alignment with current regulatory expectations.
• Serve as a cross‑functional lead for key initiatives relating to Quality metrics and reporting.
• Collaborate with study personnel to ensure documentation review and corrections are complete throughout regulated studies and during QA audits.
• Act as Document Coordinator to track version changes of controlled documents, and distribution and training of new versions.
• Assist with maintaining the master schedule.
• Assist with development or revisions of SOPs
• Lead Quality analytics processes and develops analysis procedure and reporting mechanisms to improve GxP compliance.
• Support QC review/approval of clinical data generated from biomarker assays through analytical and cell‑based assay methods.
• Participate in review of protocols, methods, reports, batch records and related GLP/GcLP source documents to actively manage data and documents by using various software like Excel, Lab Vantage LIMS (Laboratory Information Management System) database for clinical phase studies.
• Produce training manuals for the scientific and technical staff to ensure best practices are implemented.
• Collaborate with QA team and other functions towards the continued evolution of the Quality Management System (QMS) and execution of risk‑based management solutions.
• Coordinate with internal and external groups to identify appropriate solutions to improve on clinical data analysis and
• Operate at a consistent and exemplary level of efficiency, producing high quality and accurate results, in a fast‑paced environment.

• Bachelor's / Master’s/ PhD degree in Pharmaceutical Sciences or related industry with strong background in quality data analytics
• 4 to 8 years of relevant clinical laboratory experience in pharmaceutical industry or CROs
• Knowledge in various lab‑based techniques such as immunoassays, cell‑based assays, cytometry, and other platforms for the investigation of…