Sr. Manager, Packaging & Labeling

Position Title: Sr. Manager, Packaging & Labeling Location: Remote Cabaletta Bio (Nasdaq: CABA) is a late-stage clinical biotechnology company focused on developing and launching curative targeted cell therapies designed specifically for patients with autoimmune diseases. The CABA™ platform encompasses two complementary strategies which aim to advance the discovery and development of engineered T cell therapies with the potential to become deep and durable, perhaps curative, treatments for a broad range of autoimmune diseases. The lead CARTA (Chimeric Antigen Receptor T cells for Autoimmunity) strategy is prioritizing the development of rese-cel, a 4-1BB-containing fully human CD19-CAR T cell investigational therapy. Rese-cel is currently being evaluated in the RESET™ (REstoring SElf-Tolerance) clinical development program spanning multiple therapeutic areas, including rheumatology, neurology and dermatology. Cabaletta Bio’s headquarters and labs are located in Philadelphia, PA. For more information, please visit www.cabalettabio.com and connect with us on LinkedIn. 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 : Reporting to the Director, Network Planning, the Sr. Manager, Packaging & Labeling serves as the primary technical expert for the design, qualification, and technology transfer of clinical and commercial label, artwork, and packaging configurations across our global network of Contract Development and Manufacturing Organizations (CDMOs), ensuring robust chain of identity (COI) and chain of custody (COC) throughout. Responsibilities : Labeling Develop and standardize patient-specific labeling strategies across CMOs, clinical sites, depots, and logistics providers, providing oversight to ensure consistent execution without direct operational ownership. Define standards for label readability, human factors, and required data elements; ensure label performance under cryogenic, condensation, and transport conditions. Review packaging specifications, labeling content, and artwork for accuracy and compliance; own SOPs, specifications, and governance, including change control, deviations/CAPAs, and reconciliation/destruction oversight. Ensure labeling meets global regulatory requirements (FDA, EMA, Annex 13, country-specific rules) and support IND/BLA filings and inspections Establish validation strategies ensuring 21 CFR Part 11 and GMP compliance, including review and approval of IQ/OQ/PQ and vendor validation documentation Packaging Design, qualify, and validate patient-specific, temperature-controlled packaging systems (cryogenic shippers, LN2 dewars, ambient kits; e.g., ≤ -150°C vapor phase LN2, refrigerated) to maintain chain of identity and product integrity. Ensure packaging supports vein-to-vein logistics timing constraints; manage container closure integrity and compatibility with cryogenic storage and handling. Perform risk assessments for packaging failures impacting patient material. Support scale-up network expansion, including new CMOs, new regions, and the clinical-to-commercial transition. Other related duties, as assigned. Qualifications : Bachelor's degree or equivalent (preferred concentration in Engineering, Supply Chain, Packaging Science, or a related field). 5–7 years of experience in labeling, packaging, or artwork management within biopharmaceutical, cell therapy, or regulated GMP manufacturing environments; relevant experience in autologous cell & gene therapy is ideal. Working knowledge of FDA, EMA, and Annex 13 labeling requirements; experience supporting IND/BLA filings preferred. Experience with 21 CFR Part 11, GMP, and validation practices (IQ/OQ/PQ). Familiarity with cryogenic or cold-chain packaging and patient-specific (autologous) cell therapy supply chains strongly preferred. Demonstrated ability to manage cross-functional relationships and external vendor/CMO oversight without direct operational authority. Strong project management, documentation, and change-control skills. 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. 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. For the Recruiter: #LI-REMOTE