Senior Director, Apheresis Operations

This is a fully remote position, open to applicants in Pennsylvania.

📋 Description

• Provide strategic and operational leadership for global leukapheresis initiatives that support clinical trials and commercial cell therapy programs.

• Oversee the development, qualification, and performance management of a global network of apheresis collection centers.

• Build and lead a high-performing team dedicated to apheresis operations.

• Identify, recruit, and onboard skilled professionals in apheresis operations.

• Establish and sustain a qualified global network of apheresis centers.

• Create operational frameworks for site onboarding, qualification, training, and performance monitoring.

• Develop, implement, and maintain standard operating procedures (SOPs) and quality standards for apheresis.

• Engage in site qualification visits and method transfer activities.

• Align the capacity of the apheresis network with clinical development timelines and strategies for commercial launch.

• Supervise scheduled apheresis collections that support clinical trials and commercial manufacturing.

• Assist in deviation investigations, the implementation of corrective and preventive actions (CAPA), and root cause analysis.

• Collaborate with regulatory and quality teams on submissions, protocol adherence, and GMP standards.

• Act as a subject matter expert on apheresis procedures, site readiness, and product collection processes.

⛳️ Requirements

• Bachelor’s degree in nursing or an equivalent life sciences qualification.

• Over 10 years of experience in apheresis operations management.

• Preferably possess hands-on experience within a cell and gene therapy biotech company.

• Extensive knowledge of apheresis equipment, donor/patient interactions, and collection/processing protocols.

• Familiarity with GCPs, GMPs, AABB, FACT/JACIE, FDA, EMEA, and MHRA regulations.

• Willingness to travel domestically 30–50% of the time.

• Capability to work effectively, efficiently, and independently.

• Strong problem-solving abilities and excellent customer service skills.

• Ability to excel in a fast-paced, dynamic biotech environment with competing priorities.

• Registered Nurse (RN) preferred.

• Experience in commercial gene or cell therapy is highly preferred.

• Certification from ASCP, AABB, or apheresis-specific credentials is preferred.

• Familiarity with cryopreservation and CAR-T manufacturing processes is preferred.

• Authorization to work in the United States must be addressed in the application.

🏝️ Benefits

• Commitment to employee well-being and ongoing personal growth.

• Opportunities for professional development.

• Competitive benefits package.

• Paid time off (PTO).

• Stock option plans.