Responsibilities Include
- Optimize and qualify analytical methods that utilize flow cytometry, qPCR/digital PCR, MSD, ELISA, or other technologies, as required to evaluate purity, identity, potency of in-process and final lentiviral vectors, CAR T cells and CAAR T cells.
- Execute quality control assays to evaluate in-process and final lentiviral vectors, CAR T cells and CAAR T cells, as well as stability samples from in-house and external partners.
- Assist to develop new analytical methods used to assess advanced gene transfer and gene editing modalities.
- Assist to author analytical development report, assay validation report and other technical documents for technical correctness and regulatory compliance.
- Be SME/trainer in analytics and participate in technical troubleshooting and problem investigation.
- Prepare, evaluate, and present data internally to cross functional teams.