Clinical-stage cell and gene therapy company
San Diego, CA
Scientist, Cell Based Assays, Analytical Development
The Scientist, Cell Based Assays, Analytical Development will work with the Tech Ops team to develop and/or optimize cell-based asays for cell product characterization and release. The Scientist participates in laboratory activities to support process development, evaluate and develop new assay methods, and perform product characterization for CAR-T cell products. He/she is also involved in assay optimization, standardization, and transfer to internal or external QC labs.
This role includes performing assay development experiments, documenting methods and materials, writing SOPs/reports/CMC sections of IND, etc.
- PhD in a relevant, scientific discipline
- Expertise in cell-based assay development, potency assay development, analytical method development and CGMP guidance, preferably in the gene and cell therapy industry
- Proven leadership in method optimization and remediation, CMC tech-transfer, analytical control strategies and method qualification/validation
- Demonstrated proficiency in experimental design, data analysis, control charts and capability assessments using Design of Experiments (DoE)
- In depth experience in analytical techniques such as Flow cytometry, qPCR, ddPCR, Nanodrop, Fragment Analyzer, ELISA, Isoplexis, Nanostring, metabolic analysis, HPLC and potency assays
- Experience with the development and optimization of NGS assay protocols a plus
- Development, transfer, and qualification of cell-based assays for QC release testing and product characterization
If you meet the requirements above and would like to be considered for this position, apply on-line now to be contacted with further details. This is not a fully remote role.