The Fountain Group is currently seeking a ---Associate Scientist for a prominent client of ours. This position is located in San Diego, CA Details for the position are as follows:
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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
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