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Cabaletta Bio (Nasdaq: CABA) is a clinical-stage biotechnology company focused on the discovery and development of engineered T cell therapies that have the potential to provide a deep and durable, perhaps curative, treatment for patients with autoimmune diseases. The CABA™ platform encompasses two strategies: the CARTA (chimeric antigen receptor T cells for autoimmunity) strategy, with CABA-201, a 4-1BB-containing fully human CD19-CAR T, as the lead product candidate being evaluated in the RESET™ (REstoring SElf-Tolerance) clinical trials in systemic lupus erythematosus, myositis, systemic sclerosis and generalized myasthenia gravis, and the CAART (chimeric autoantibody receptor T cells) strategy, with multiple clinical-stage candidates, including DSG3-CAART for mucosal pemphigus vulgaris and MuSK-CAART for MuSK myasthenia gravis. The expanding CABA™ platform is designed to develop potentially curative therapies that offer deep and durable responses for patients with a broad range of autoimmune diseases. Cabaletta Bio’s headquarters and labs are located in Philadelphia, PA. For more information, visit www.cabalettabio.com and follow us on LinkedIn and X (Twitter).
Uniquely Differentiated. Rapid. Elegant.
At Cabaletta, we are driven by the shared mission of developing a new type of therapy, where patients’ own cells are used to fight disease. We are building a culture grounded in the knowledge that success in the Cabaletta mission lies in the hands of individuals across every aspect of the company. To nurture this, we make an active commitment to the well-being and continuous growth of each person who joins our team. In this way, we are not only working to improve the lives of patients, but of everyone involved.
About the Position
Reporting to the Senior Director GCP Compliance, the TMF Inspection Readiness Associate is an integral member of Quality and Compliance team. The position is responsible for the complete and accurate Trial Master Files through documentation of quality, consistency, and timely filing across all assigned clinical trials, consistent with the Trial Master File specifications, applicable SOPs, ICH/GCP guidelines, regulatory agency and any other local authority requirements. Key deliverables include monitoring and assessing the overall health of the TMF, ensuring quality, completeness, and timeliness in the eTMF for all studies, working with the study teams and vendors. Subject Matter Expert for TMF/eTMF, spans across all therapeutic areas and research phases, collaborates with cross-functional, clinical research studies throughout the lifecycle of the trials.
Responsibilities:
Qualifications:
Degree Requirements
Key Competency Requirements
Our name – Cabaletta – is derived from the operatic term that represents a rapid, repetitive, and technically challenging section of an operatic aria, designed to showcase the skills of the lead singer. Analogously, Cabaletta Bio strives to achieve rapid and repetitive product development, building on our indication prioritization and biologic platform that targets the driver of specific autoimmune diseases without the need for long-term immunosuppression.
For more information, please visit https://www.cabalettabio.com/join-our-crew
Our most important asset is our people, and we offer competitive benefits, PTO, and stock option plans.
Cabaletta Bio is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability, protected veteran status or any other basis protected by applicable law.
Full Time
Scientific Services
$73k-94k (estimate)
03/27/2024
05/26/2024
cabalettabio.com
PHILADELPHIA, PA
25 - 50
2017
Public
STEVEN NICHTBERGER
<$5M
Scientific Services
Cabaletta Bio is a biopharmaceutical company that researches and develops T cell-based therapeutics for the treatment of autoimmune diseases.