Calibr, a division of The Scripps Research Institute (Calibr) is a not-for profit research institute located in La Jolla, California. Calibr is focused on innovative early stage translational research in the areas of regenerative medicine, cancer biology, cardiovascular and metabolic disease, immunology and infectious disease.
Calibr, a division of The Scripps Research Institute (Calibr), is seeking talented Research Scientist candidates in the area of Cellular Manufacturing process development, to join our team.
This position will carry out cellular manufacturing responsibilities with a team of interdisciplinary scientists to translate novel cellular therapies for the treatment of cancer into human clinical trials. Specifically, this position will be integral in the translation of Calibr’s universal, switchable CAR-T cell platform into first in human clinical trials. The Research Scientist will have responsibilities including in-house process development of cellular manufacturing, integration with analytical development and qualification, and tech transfer to contract manufacturing organizations, that will shape the program’s manufacturing & supply strategy.
Calibr’s exciting and dynamic research environment offers a unique perspective on bench to bedside translational research. Calibr’s open lab space design and collaborative research environment encourage the seamless flow of ideas within and between research groups. Further, the affiliation with The Scripps Research Institute links world-class basic research innovation with patient-centric research initiatives, elevates the scientific discourse and accelerates the discovery and development of new medicines. This opportunity is ideal for Research Scientists with a passion for science and a strong drive to make an impact.
Essential Duties and Responsibilities:
• Work within a team of scientists on Calibr’s cellular manufacturing process development for a first-in-human CAR-T cell therapy clinical trial
• Participate in CMC development, manufacturing, quality, and supply chain projects to support clinical development
• Collaborate closely with our cutting-edge basic research teams to translate protocols and scale processes to GMP
• Author technical and scientific documents including SOPs, review Master Batch Records, study protocols and reports.
• Hands-on, wet lab experiments and training of personnel are core to the scope of work, including cell culture, cell isolation, lentiviral transduction, and cryopreservation
• Design process development experiments, including DOE, process scale-up, operation of related equipment, and the development and incorporation of appropriate analytical testing
• Work closely with CROs and CMOs in cellular manufacturing and analytical development
• Prepare and author detailed protocols, reports, and CMC documentation to support regulatory filings
• Outstanding background in cell culture.
• Hands-on experience with cellular manufacturing and an understanding of CMC related to CAR-T cell therapies is essential
• Experience with close, automated manufacturing systems is preferred
• Experience and knowledge of immunotherapy is strongly preferred.
• Experience in T cell biology, tumor immunology, as well as other immune components is preferred.
• Knowledge of compliance and quality management systems is preferred.
• Knowledge in flow cytometry and T cell phenotyping is required.
• Experience with cell transfection and transduction systems is preferred.
• Experience using Prism, FlowJo, JMP, and Office software is important.
• MS, or PhD in biology, chemical biology, biochemistry or related area with 2-6+ years’ experience post training and a minimum of 2+ years’ experience in industry
• Impeccable attention to details, and excellent ability to perform hands on experiments, research, design, and organize project designs and maintain detailed documentation.
• Highly motivated, creative, and devoted to project goals.
• Able to collaborate proficiently and communicate effectively with colleagues and management teams.
• Able to contribute in a meaningful way to scientific discourse.