Senior Director, Apheresis Operations

🔥 0 minutes ago

🔔 Pennsylvania – Remote

🔔 Pennsylvania – Remote

⏰ Full Time

🟠 Senior

⚙️ Operations

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Cabaletta Bio

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2017

🧬 Biotechnology

🏥 Healthcare

💊 Pharmaceuticals

Biotechnology • Healthcare • Pharmaceuticals

Cabaletta Bio is a clinical-stage biotechnology company developing engineered T cell therapies to treat autoimmune diseases. Using its CABA® (Cabaletta Approach to B cell Ablation) platform, the company is advancing rese-cel, a fully human CD19 CAR T cell candidate with a 4-1BB co-stimulatory domain, in multiple RESET™ Phase 1/2 trials for systemic lupus erythematosus, myositis, systemic sclerosis, generalized myasthenia gravis, and pemphigus vulgaris. Cabaletta aims to deliver deep, durable, potentially curative responses by transiently eliminating B cells to reset immune tolerance, and emphasizes patient-centered development and broad indication expansion across rheumatology, dermatology, and neurology.

📋 Description

• Provide strategic and operational leadership of global leukapheresis activities supporting clinical trials and commercial cell therapy programs • Manage development, qualification, and performance oversight of a global network of apheresis collection centers • Build and lead a high-performing apheresis operations team • Identify, recruit, and onboard experienced apheresis operations professionals • Establish and maintain a qualified global network of apheresis centers • Develop operational frameworks for site onboarding, qualification, training, and performance monitoring • Develop, implement, and maintain apheresis SOPs and quality standards • Participate in site qualification visits and method transfer activities • Align apheresis network capacity with clinical development timelines and commercial launch strategies • Oversee scheduled apheresis collections supporting clinical trials and commercial manufacturing • Support deviation investigations, CAPA implementation, and root cause analysis • Partner with regulatory and quality teams on submissions, protocol compliance, and GMP standards • Serve as subject matter expert for apheresis procedures, site readiness, and product collection processes

🎯 Requirements

• Bachelor’s degree in nursing or equivalent life sciences degree • 10+ years of apheresis operations management experience • Preferably 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, and MHRA regulations • Willingness to travel domestically 30–50% of the time • Ability 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 • RN preferred • Commercial gene or cell therapy experience greatly preferred • ASCP, AABB, or apheresis-specific certification preferred • Familiarity with cryopreservation and CAR-T manufacturing processes preferred • Authorization to work in the United States addressed in the application

🏖️ Benefits

• Commitment to employee well-being and continuous growth • Professional development opportunities • Competitive benefits • PTO • Stock option plans