Viral Vector Analytical Development Role for Cell Therapy Startup
Unique Bay Area cell therapy biotech with top-notch scientific and engineering talent and a collegial work culture that supports transparency, collaboration, and professional growth. The company is currently expanding its viral vector production and analytics capacity to enhance its cutting-edge platform technology. The analytical development team has a newly-minted role for a skilled virologist to contribute viral vector novel assay development and analytical development expertise to this rapidly-growing startup focused on NextGen therapies to enhance patient-care. Will work with some of the best minds in the industry and conduct pioneering science in a dynamic and mutually supportive work culture. As the viral vector analytics specialist within the analytical development team, will collaborate closely with viral vector process development and quality control teams to design, optimize, and execute analytical methods for viral vector characterization and release testing to optimize the company’s viral vector production projects.
- BS, MS, or PhD relevant to Biology, Immunology, or Virology (position level contingent on specificity of experience)
- Industry 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 be part of and promote a dynamic, collaborative, and collegial work culture.
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