- South San Francisco, California, United States
- 5+ years
Scientist I in the Development Sciences Biologics CMC Drug Substance Cell Line Development Group, responsible for CHO cell line development and molecular characterization for GMP applications.
Responsibilities
- Independently design, conduct, analyze, and document critical experiments supporting CHO cell-line development, cell-bank qualification, and candidate progression
- Design and generate expression vectors for monoclonal antibodies and antibody-like molecules; improve cloning, plasmid QC, and whole-plasmid sequencing workflows
- Characterize CHO cell banks for identity and transgene DNA/RNA quality using PCR/qPCR, ddPCR, DNA/RNA isolation, sequencing, and related assays
- Develop and optimize NGS workflows, including RNA-seq and molecular screening; interpret sequencing data and establish fit-for-purpose quality controls
- Author and review technical reports and documentation supporting regulated development from IND through BLA
Requirements
- Bachelor’s degree or equivalent education with typically 5 years of relevant experience
- Master’s degree or equivalent education with typically 2 years
- Nice to have: Biotechnology or pharmaceutical industry experience developing CHO cell lines for GMP applications
- Nice to have: bioinformatics workflows for DNA/RNA sequence confirmation and expression analysis
- Nice to have: IGV