Scientist II – Analytical Development

Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases. The Kyverna therapeutic platform leverages advanced T cell engineering to suppress and eliminate autoreactive immune cells at the origin of autoimmune and inflammatory diseases. Be at the forefront of cell therapy innovation by joining scientists, industry veterans and healthcare visionaries and help transform how autoimmune diseases are treatedKyverna is seeking a talented and highly motivated Scientist to support Analytical Science and Technology (AS&T) in its Technical Operations organization to help advance its mission to free patients from the siege of autoimmune disease. Reporting to the Associate Director of Analytical Science and Technology, the Scientist role is responsible for designing, performing and documenting laboratory-based studies, and providing technical expertise to support the robust transfer and qualification/validation of analytical methods of technologies including molecular (ddPCR, RT-qPCR), immunoassays (ELISA, flow cytometry), and cell-based assays (T cell culturing, cytotoxicity assay, cell viability). The AS&T team will manage the effective execution of analytical method technology transfer, troubleshooting, and validation of a range of analytical methodologies at a number of analytical contract testing sites.ResponsibilitiesDraft documentation to establish and/or improve procedures and processes for in-house testing of Process Development materials and testing of materials from contract development and manufacturing organizations.Support in-house testing of PD materials, materials from contract development and manufacturing organizations to support Kyverna’s in-process and final drug testing and product extended characterization.Work closely with Technical Development colleagues to plan, execute, analyze and trend testing results. Prepare and present clear data-driven presentations within Technical Development and Technical Operation groups.Collaborate in defining, establishing, and developing procedures and tools for sample management, tracking, data collection, and data reporting to support testing operations.Work with facilities, quality and technical development leadership to establish processes and procedures for analytical equipment operation, maintenance, and performance. Draft documentation to support these activities.In collaboration with Quality draft procedures and implement processes to support robust method development, technology transfer, and validation.Support preparation and review of CMC documentation for analytical sections of regulatory filings to multiple agencies to support Kyverna’s global regulatory strategy.Author and review clear and concise technical reports, development plans, technical protocols, and standard operating procedure documents and other documentation as neededSupport on the evaluation of novel analytics and innovative methodologies for better and faster testing and release of CAR-T cells, supporting elucidation of DP mechanisms and other important characteristics to product efficacy or safety.Other duties as assigned.RequirementsPhD with 3+ years, or Master’s degree with 5+ years of relevant pharmaceutical/ biotech experience in biological sciences (biochemistry, biology, immunology, genetics, or related area biochemistry, molecular and cell biology). T cell biology and immunology background are preferred.Hands on in analytical techniques used to interrogate ex-vivo cell therapies (CART) and LVV, including molecular techniques (ddPCR, qPCR, NGS), flow cytometry, cell culture and cell-based assays (bioassays, luciferase-based reporter systems, killing assays, etc.).Experience establishing processes and procedures to support analytical method development, equipment operation and maintenance, and sample management, testing and data reporting.Experience in method fit for purpose assessments, and assay qualification/validation in advanced therapy medicines.A strong scientific mindset and ability to effectively interrogate data to build and communicate an understanding of assay behavior and to justify data-driven proposals and recommendations.An understanding of the cGMP requirements of analysis of ex-vivo CART cell therapies.Familiarity with statistical analysis and statistical process controlEffective written and oral communication skills.Proven track record of effectively working with others to achieve group goals while contributing at a high level to solve problems and effectively manage time and priorities.

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