Principal Research Associate, Clinical Biomarker Laboratory

Location: 100% onsite in Norwood, Massachusetts, United States. Only U.S. persons are eligible due to U.S. export control requirements; visa sponsorship is not available.

Salary: $89,900–$143,800 per year, with potential bonus, incentive compensation, or equity eligibility.

Company

hirify.global develops mRNA technology and medicines across infectious disease, oncology, and autoimmune disease programs.

What you will do

• Develop, qualify, validate, and implement ligand-binding and cell-based assays for biomarker and immunogenicity testing.
• Perform assay development, optimization, clinical sample testing, data analysis, and documentation in a regulated clinical laboratory.
• Establish quality data standards, metrics, reporting processes, and risk-based solutions aligned with GLP, ICH, GCP, and existing SOPs.
• Review protocols, methods, reports, batch records, source documents, and clinical data generated through biomarker assays.
• Coordinate controlled documents, SOP updates, training materials, study schedules, and audit-related corrections.
• Collaborate with laboratory leadership, biostatisticians, QA, Quality/Compliance, study personnel, and internal and external partners.

Requirements

• Bachelor’s, master’s, or PhD degree in pharmaceutical sciences or a related field.
• 4–8 years of relevant clinical laboratory experience in the pharmaceutical industry or a CRO.
• Experience with immunoassays, cell-based assays, cytometry, biomarker platforms, and clinical-phase laboratory studies.
• Knowledge of bioanalytical method validation, data integrity, LIMS/ELN/LES systems, RYZE, CDISC standards, and data collection formats.
• Experience with GxP or CAP/CLIA- and GLP-regulated laboratories, quality analytics, documentation, and data management.
• Must qualify as a U.S. person under U.S. export control laws; visa sponsorship is unavailable.

Nice to have

• Experience with virus neutralization, functional antibody, cell culture-based neutralization, or hemagglutination inhibition assays.
• Experience developing study-specific Data Management Plans and Data Cleaning Plans.
• Experience in laboratory management, digital automation, or statistical analysis methodologies.

Culture & Benefits

• 100% onsite work supporting direct collaboration, mentorship, and hands-on laboratory operations.
• Healthcare and voluntary benefit programs, including family planning, fertility, adoption, and surrogacy support.
• Fitness, mindfulness, and mental health resources.
• Paid vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown.
• Savings and investment programs plus location-specific benefits.