Senior Immunoassay & Cell-Based Bioanalysis Scientist

Initial Therapeutics, Inc.; Norwood (MA); On-site; USD 74,000 - 118,000; Full time

Benefits offered by this job

Competitive healthcare

Well-being resources

Family planning benefits

Generous paid time off

Savings and investments

Location-specific perks

Job summary

Moderna seeks a Senior Research Associate for the Clinical Biomarker Laboratory, Immunoassay and Cell Based Assay group. You will develop, qualify, validate, transfer, and implement cell-based and ligand-binding assays to characterize vaccine-induced immune responses and support clinical programs.

You will independently execute assay development, qualification/validation, clinical sample testing, data analysis, troubleshooting, and regulatory documentation in a regulated clinical lab environment.

Qualifications

• Bachelor's/Master's/PhD in Pharmaceutical Sciences or related field with strong background in quality data analytics.
• 2–5 years of relevant clinical laboratory experience in pharma industry or CROs.
• Experience generating, reviewing, and documenting regulated clinical bioanalytical data per GxP/GcLP.
• Hands-on experience with ligand-binding immunoassays (ELISA, ECL) for immunogenicity/biomarker testing.
• Knowledge of QC/LIMS data integrity and data management.
• Experience with GLP/CAPA documentation and regulated lab environment.

Responsibilities

• Prepare and review assay methods, qualification/validation plans and reports for regulated bioanalysis.
• Analyze assay data, identify variability sources, document investigations and troubleshoot.
• Perform clinical sample testing with strict chain of custody and data traceability.
• Execute ligand-binding assays for vaccine immunogenicity and biomarker endpoints, including reagent qualification.
• Run neutralization/functional antibody assays using established platforms; assess controls and readouts.
• Maintain mammalian cell culture systems and monitor cell performance per SOPs.
• Lead development, qualification, validation, transfer, and routine clinical testing of cell-based and immunoassay methods.
• Ensure GLP/GxP data standards and QA alignment across studies.

Skills

Mammalian cell culture

Cell-based assays

Immunoassays

Virus neutralization

Data analysis

Regulatory documentation

GxP/GLP experience

Quality/compliance

Education

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

Tools

LIMS (LabVantage)

ELISA / electrochemiluminescence

MSD platform

Job description

Moderna seeks a Senior Research Associate for the Clinical Biomarker Laboratory, Immunoassay and Cell Based Assay group. You will develop, qualify, validate, transfer, and implement cell-based and ligand-binding assays to characterize vaccine-induced immune responses and support clinical programs.

You will independently execute assay development, qualification/validation, clinical sample testing, data analysis, troubleshooting, and regulatory documentation in a regulated clinical lab environment.