Senior Analyst

Job Summary The Scientist – Immunogenicity Assays will be responsible for the development, validation, and execution of cell-based and ligand-binding immunoassays to assess immune responses to biologics, peptides and vaccines. The role requires strong hands-on expertise in Multiplex assays, Flow Cytometry (FACS), and ELISPOT , along with a solid understanding of immunology principles. Key Responsibilities Immunogenicity & Cell-Based Assays Design, optimize, and execute immunogenicity assays to assess Innate and Adaptive immune responses.

Perform ELISPOT assays for T-cell response evaluation. Conduct Flow Cytometry (FACS) experiments including immunophenotyping, intracellular cytokine staining (ICS), and activation marker analysis. Perform Multiplex assays (e.g., Luminex, MSD, cytokine/chemokine profiling) for immune biomarker assessment.

Method Development & Validation Develop, optimize, and validate assays following GLP/GCLP , FDA, and EMA bioanalytical guidelines. Establish assay parameters including sensitivity, specificity, precision, and robustness. Troubleshoot assay performance and implement continuous improvements.

Data Analysis & Documentation Analyze and interpret complex immunological data using appropriate software. Generate high-quality technical reports, study documentation, SOPs, and validation reports. Ensure data integrity and compliance with regulatory and quality standards.

Qualifications PhD / MSc in Immunology, Biotechnology, Life Sciences, or a related discipline. Experience 6 years of hands-on laboratory experience in immunogenicity or immune monitoring assays. Strong practical experience with: Multiplex platforms (Luminex, MSD,) Flow Cytometry (FACS) including multi-color panel design ELISPOT assays Experience working in GLP, GCP environments is highly desirable.

Technical Skills Deep understanding of innate and adaptive immune responses. Proficiency in: Flow cytometry panel design and compensation Cytokine profiling and immune biomarker analysis PBMC isolation, cell culture, and stimulation assays Familiar with bioanalytical validation requirements and regulatory expectations.