Our RESETTM clinical trials with rese-cel (investigational CD19-CAR T cell therapy) in lupus, myositis, systemic sclerosis, and pemphigus vulgaris are now recruiting.
Senior Director, Apheresis Operations
Remote
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.
• 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.
• 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
