Associate Scientist

Job Title: Associate Scientist
Location: San Diego, CA (Onsite)
Pay Rate: $27.59–$44.82/hr
Duration: 6 months

Job Description

Associate Scientist will support analytical development activities for cell therapy products, focusing on assay development, validation, and product characterization. The role involves execution of cell-based assays, analytical method development, and laboratory testing to support GMP release and process development for CAR-T and related cell therapy programs.

Key responsibilities include:

• Develop and optimize cell-based assays for product characterization and release testing
• Perform analytical testing, qualification, and validation in GMP-regulated environment
• Execute cell culture processes and analyze samples for process and product evaluation
• Support assay transfer to QC laboratories and lifecycle management
• Generate and document analytical data, SOPs, and technical reports
• Evaluate reagents, materials, and analytical technologies for assay robustness
• Conduct process assessment studies and support critical quality attribute (CQA) analysis

Education

• Bachelor’s or Master’s degree in Biology, Immunology, Biotechnology, or related field
• 5+ years of relevant experience in biotech or cell therapy environment

Required Skills

• Cell-based assay development and validation for biologics or cell therapy
• Human T-cell biology and cellular immunology techniques
• Flow cytometry and immunoassays (ELISA, cell-based assays)
• Aseptic cell culture (primary cells and cell lines)
• GMP analytical testing and method qualification/validation
• Knowledge of ICH, USP, and EP guidelines for analytical methods
• Laboratory documentation, SOP writing, and assay transfer to QC
• Data analysis and experimental documentation in regulated environments

Preferred Skills

• Cell therapy (CAR-T) product characterization and release testing
• In vitro T-cell functional assays (potency, cytotoxicity, proliferation, Luminex)
• Molecular techniques (qPCR, ddPCR, electrophoresis)
• Design of Experiments (DoE) for assay development
• Experience with analytical method lifecycle management
• Exposure to GMP QC labs and assay standardization