Viral Vector Assay Development, Cell Therapy
Fast growing Bay Area cell therapy and viral vector company with top-notch scientific talent and a collegial work culture that promotes transparency, collaboration, and professional growth. This young, post-IPO biotech company is expanding its Viral Vector Analytics capacity to enhance its cutting-edge platform technology. The company's Analytical Development team has a newly-minted role for a skilled scientist with a PhD and viral-vector assay expertise and a strong virology foundation to design and execute novel assays for analytical development. Would work with top scientific talent from diverse disciplines and conduct pioneering science in a dynamic and mutually supportive environment. As the viral vector specialist within the Analytical Development team, would collaborate closely with Process Development and QC teams to design, optimize, and execute analytical methods for viral vector characterization and release testing to optimize viral vector production and cell therapy projects.
- PhD in a discipline relevant to Virology.
- Industry experience [or equivalent academic experience] applying critical analysis skills to viral-vectors for gene, cell, or stem-cell therapies.
- Expertise in viral vector characterization assays that includes hands-on experience in viral titer assays, viral particle measurement assays, residual host cell DNA/plasmid assays, and viral-lot impurity assays.
- Experience in analytical method development, analysis, and documentation for characterization and stability monitoring of clinical viral vectors to optimize safety, strength, purity, and quality.
- Experience in tech transfer of viral vector analytical methods to QC and internal and external testing and manufacturing labs.
- Troubleshooting skills to assess performance of existing and novel viral assays.
- [Skills of high interest include qPCR, flow cytometry, ELISA, Southern blot, and impurity assays such as HCP, BSA, and nuclease using qPCR or ELISA).
- Organization and documentation experience in creation and review of technical and regulatory documentation in compliance with FDA and ICH regulatory standards for gene and cell therapy.
- Advanced communication, multi-tasking, and relevant computer skills.
- Desire to join a dynamic, collaborative, and highly-committed team of scientists and engineers.
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