Clinical-stage cell and gene therapy company
San Diego, CA
Process Development Scientist I/II, Analytical Development - Raw Materials (title dependent on experience)
This individual will work with the tech ops team to develop and/or optimize cell-based assays for cell product and raw materials characterization and release. The Process Development Scientist I/II will participate in laboratory activities to support process development, evaluate and develop assay methods, and perform raw material and product characterization for CAR-T cell products.
The Process Development Scientist I/II will be focused more on the raw materials - monitoring, version control, comparability analysis.
- PhD in a relevant, scientific field
- The ability to develop analytical assays for characterization of critical raw materials using molecular biology techniques (primer design, PCR, NGS).
- Experience in cell-based assay development, potency assay development, analytical method development and CGMP guidance, preferably in the gene and cell therapy industry.
- Demonstrated proficiency in experimental design, data analysis, control charts and capability assessments using Design of Experiments (DoE).
- Experience in analytical techniques such as qPCR, ddPCR, RT-PCR, Fragment Analyzer, Flow cytometry, ELISA, HPLC, SDS-PAGE, SPR, Nanodrop.
- Experience with the development and optimization of NGS assay protocols a plus.
- Prior experience with CAR-T manufacturing process (leukopak processing, T cell isolations, use of Prodigy) is a plus.
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.