Senior Director, Apheresis Operations

Position Title: Senior Director, Apheresis Operations Location: Remote Department: Supply Chain 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 : The Senior Director, Global Apheresis Operations is responsible for providing both strategic and operational leadership of global leukapheresis activities that support clinical trials and commercial cell therapy programs. This position manages the development, qualification, and performance oversight of a global network of apheresis collection centers, which procure the cellular starting materials used in advanced therapy manufacturing. The Senior Director works collaboratively across clinical operations, quality, regulatory affairs, supply chain, manufacturing, and commercial teams to ensure that apheresis collections meet regulatory requirements and internal standards. This role also serves as a subject matter expert for apheresis procedures, site readiness, and product collection processes, contributing to clinical development, regulatory submissions, and commercial launch readiness. Responsibilities : Build and lead a high-performing apheresis operations team, fostering a culture of accountability, continuous improvement, and excellence through clear goal-setting, regular feedback, and professional development opportunities Identify, recruit, and onboard experienced apheresis operations professionals to build the global network team Establish and maintain a sustainable global network of qualified apheresis centers capable of supporting patient enrollment and manufacturing demand. Develop and implement operational frameworks for site onboarding, qualification, training, and performance monitoring. Develop, implement, and maintain apheresis SOPs and quality standards to ensure compliance. Participate in site qualification visits and method transfer activities for new clinical and commercial collection centers. Collaborate with senior leadership to align apheresis network capacity with clinical development timelines and commercial launch strategies. Oversee operational execution of scheduled apheresis collections supporting clinical trials and commercial manufacturing. Support deviation investigations, CAPA implementation, and root cause analysis related to apheresis collections. Partner with regulatory and quality teams to prepare submissions, ensure protocol compliance, and maintain GMP standards. Required Qualifications : Bachelor’s degree in nursing or equivalent life sciences degree, RN preferred 10+ years of apheresis operations management experience, preferably with hands-on experience with a cell and gene therapy biotech company Deep knowledge of apheresis equipment, donors/patients, and collection/processing protocols. Good knowledge of GCPs, GMPs, AABB, FACT/JACIE, FDA, EMEA, MHRA, regulations. Willingness to travel domestically (30-50% of time). Highly motivated, proactive and organized. Able to work effectively, efficiently and independently. Strong problem-solving and customer service skills. Ability to thrive in a fast-paced, dynamic biotech environment with competing priorities. Preferred Qualifications : Experience in commercial gene or cell therapy is greatly preferred ASCP, AABB, or apheresis-specific certification Familiarity with cryopreservation and CAR-T manufacturing processes 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. #LI-REMOTE