Philadelphia, PA
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 cures, where a patients’ own cells are used to fight disease. We are building a culture grounded in the knowledge that successful cures can be achieved for patients if every member of the Cabaletta is focused on the success of the team. To nurture this, we make an active commitment to the well-being and continuous growth of each employee who joins the team. In this way, we are not only working to improve the lives of patients, but of everyone involved. #CabalettaCrew.
We’re proud to be a Great Place to Work-Certified™ company! #GPTWcertified Check out what our employees say makes working here so great: Working at Cabaletta Bio Inc | Great Place to Work®
About the Position:
The Associate Clinical Sample Manager will support the management and coordination of the day-to-day clinical sample activities for cell therapy trials. This role ensures the accurate tracking, handling, and documentation of clinical samples throughout the lifecycle of the study. The position requires close collaboration with clinical teams, external vendors, and laboratories to ensure samples are processed and analyzed according to study protocols and regulatory requirements.
Responsibilities:
- Assist CSM to maintain logs to track the real time movement of samples from the clinical sites to the central laboratory or third-party labs
- Assist with clinical sample reconciliation of the central and local labs inventory with EDC as needed
- Work closely with IHCRA’s to initiate kit shipments to the clinical sites for site startup and maintain up to date lab contact distribution lists
- Schedule shipments from central lab to third party lab to dispatch within stability window for critical clinical samples
- Review and approve shipping manifests as needed
- Execute virtual Central Lab SIVs trainings with clinical site’s as needed and attend virtual site SIV’s and present Central/Local Lab information where applicable
- Second reviewer for Sample Management generated documents and central lab generated documents and manuals
- File minutes and agendas from internal or external Sample Management related meetings and vendors
- File patient sample requisition forms (SRFs) along with associated data clarification forms (DCFs) in patient files
- Assist CSM in resolving central lab discrepancies in collaboration with clinical site coordinators via data clarifications forms as needed
Qualifications:
- Bachelor’s degree in Life Sciences, Biotechnology, or a related field. Advanced degree preferred.
- Minimum of 2 years of experience in clinical sample management, preferably in a cell therapy or biopharmaceutical setting.
- Strong understanding of GCP, GLP, and regulatory requirements for clinical sample handling.
- Proficiency with laboratory information management systems (LIMS) and other relevant software.
- Excellent organizational skills and attention to detail.
- Strong communication and interpersonal skills.
- Ability to work collaboratively in a team environment.
- Problem-solving skills and ability to manage multiple tasks simultaneously.
- Strong team orientation and passion for continuous self-development.
- Experience in the biotech industry or in a startup industrial setting is preferred.
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 based on 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.
Cabaletta Bio, Inc. does not accept unsolicited resumes from recruiters, employment agencies, or staffing firms. To conduct business with Cabaletta, a Master Services Agreement (MSA) must be executed and confirmed prior to submitting any information relating to a potential candidate. Without a signed MSA, Cabaletta shall not be responsible to any individual or entity for any payment relating to any form of fee or compensation.
And, if a resume or candidate is submitted by a recruiter, an employment agency, or a staffing firm without a fully executed MSA, Cabaletta has the unrestricted right to pursue and hire any of those candidate(s) without any legal or financial responsibility to the recruiter, agency, and/or firm.