Scientist, QC Analytical
Catalent
Catalent seeks a Quality Control Bioanalytical Scientist to perform analytical and bio-analytical testing for cell therapy products in a GMP-regulated laboratory. The role involves in-process, release, characterization, and stability testing, with responsibility for data generation, interpretation, method validation, and regulatory compliance at the Princeton, NJ facility.
Responsibilities
- Perform routine and non-routine QC testing including flow cytometry, ddPCR/qPCR, ELISA, cell count and viability assays for cell therapy products
- Support method transfer, verification, qualification, and validation activities with protocol execution and report generation
- Analyze and interpret assay performance data to evaluate method reliability, system suitability, and laboratory performance indicators
- Investigate analytical deviations, assay failures, and out-of-specification results; support root cause analysis and corrective actions
- Collaborate with QA, Manufacturing, and Regulatory teams on analytical control strategies and technical issue resolution
Requirements
- Bachelor's degree in Biochemistry, Analytical Chemistry, Molecular Biology, Microbiology, or related field with 4+ years relevant experience; Master's preferred
- Hands-on experience with flow cytometry, ddPCR/qPCR, automated cell count and viability assays, and ELISA or multiplex immunoassays
- Experience with analytical method transfer, verification, validation, and troubleshooting in regulated GMP environments
- Familiarity with cell therapy GMP manufacturing, aseptic sampling, stability testing, and advanced therapy regulatory expectations
- Visual acuity of 20/20 with or without correction and ability to identify colors on Ishihara charts
- Knowledge of statistical analysis, assay trending, and method performance monitoring
Vacancy posted 3 days ago
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