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 hemagglutination 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.

Here’s What You’ll Do:

• 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, LabVantage 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.

Here’s What You’ll Bring to the Table:

• 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 biomarkers in clinical phase studies.

• Knowledge of Bioanalytical method validation for Industry is preferred.

• Knowledge of data management tools, and data integrity requirements such as with QC review of LIMS/ ELN/ LES system, RYZE, CDISC standard and data collection formats.

• Prior experience in Developing and maintaining study-specific data management documentation, Data Management Plan, and Data Cleaning Plan documentation is preferred.

• Previous experience in working in GxP or CAP/ CLIA, GLP regulated laboratory is highly preferred.

• Previous experience in Lab management and Digital Automation is.

• Proficiency with Microsoft Office Suite (Outlook, Excel, Word, etc.). Proficiency with statistical analysis methodologies is a plus.

• Attention to detail, organizational ability, judgement, team player attitude and effective communication skills.

• Demonstrated ability of multi-tasking

Our Working Model

As we build our company, we have always believed that an in-person culture is critical to our success. This role is 100% onsite, reflecting the importance of being physically present to support the work, collaborate closely with colleagues, and contribute to our site-based operations.

Working onsite enables real-time collaboration, strong team connections, direct mentorship, and the hands-on partnership needed to deliver our mission. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact.

Moderna is a smoke-free, alcohol-free, and drug-free work environment.

Pay & Benefits

At Moderna, we believe that when you feel your best, you can do your best work. That’s why our benefits and well-being resources are designed to support you—at work, at home, and everywhere in between.

• Competitive healthcare, plus voluntary benefit programs to support your unique needs
• A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
• Family planning benefits, including fertility, adoption, and surrogacy support
• Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
• Savings and investments to help you plan for the future
• Location-specific perks and extras

The salary range for this role is $89,900.00 - $143,800.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual’s position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs. The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance.

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