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Director, Patient Cell Supply Chain
POSITION SUMMARY
We are seeking a Director, Patient Cell Supply Chain to manage the day-to-day operations and execution of our vein-to-vein supply chain—coordinating patient material movement from collection to manufacturing and back to the clinical site. This individual will report to the Senior Director of Supply Chain and will play a critical role in operationalizing Lyell’s clinical programs, supporting cross-functional readiness, and ensuring that patient cell therapies move through the supply chain safely, compliantly, and on schedule.
In this role, the individual is responsible for the execution of autologous cell therapy supply chain operations across scheduling, logistics coordination, vendor management, clinical site training, and cold chain oversight. This role directly supports clinical trial execution and future commercial readiness by managing the day-to-day operational flow of patient material.
You will lead a team responsible for working with clinical sites, apheresis centers, manufacturing, and transportation partners to ensure patient materials are handled according to strict quality and regulatory standards. You’ll also own the systems, training programs, and vendor relationships necessary to maintain supply continuity across clinical programs.
Key Responsibilities
Execution of Patient Cell Supply Chain Operations
- Manage the coordination of patient scheduling, apheresis material collection, manufacturing slot assignment, and drug product return to clinical sites.
- Oversee end-to-end cold chain logistics operations, ensuring COI/COC integrity and compliance with GxP and temperature control requirements.
- Serve as the operational lead for daily supply chain activity—triaging delays, managing escalations, and ensuring patient shipments stay on track.
Vendor & Courier Oversight
- Own day-to-day relationships with specialty couriers and packaging providers; ensure compliance with SOPs and quality expectations.
- Support vendor qualification, audit preparation, and issue resolution in collaboration with Quality and Compliance.
- Coordinate courier availability and performance to meet clinical trial and manufacturing timelines.
Clinical Site Readiness & Training
- Lead the oversight and execution of training for clinical and apheresis sites on the Apheresis Manual and Drug Product Administration Manual, ensuring full procedural compliance and operational excellence.
- Develop, deliver, and update training programs to reflect evolving practices, regulatory changes, and feedback from sites.
- Support clinical site onboarding and requalification through training, documentation, mock runs, and readiness assessments.
System and Process Ownership
- Serve as the business owner for Lyell’s Cell Orchestration platform and other supply chain execution tools.
- Implement and refine digital workflows for real-time tracking, data collection, and performance monitoring.
- Leverage digital tools to improve coordination across scheduling, manufacturing, logistics, and clinical teams.
Cross-Functional Collaboration
- Act as the primary operational interface with Clinical Operations, Manufacturing, Scheduling, Quality, and Regulatory teams.
- Participate in cross-functional meetings to support patient slot planning, escalation management, and clinical site support.
- Communicate supply chain risks, operational metrics, and mitigation plans to senior management and internal stakeholders.
Team Leadership
- Lead and grow a high-performing team including direct reports and matrixed contributors across logistics, planning, and site operations.
- Provide strategic direction, coaching, and professional development opportunities to support team success and organizational growth.
Preferred Qualifications & Competencies
- Bachelor’s degree in supply chain, life sciences, logistics, or related field; advanced degree is a plus.
- 8–10 years of experience in biotechnology, pharmaceuticals, or cell and gene therapy with focus on logistics, site operations, or clinical supply chain execution.
- Direct experience supporting autologous cell therapy programs highly preferred.
- Strong understanding of cold chain management, chain of custody/identity, and GxP-compliant transport.
- Hands-on experience training and supporting clinical sites on cell handling procedures.
- Experience managing vendors, coordinating shipments, and resolving day-to-day supply chain issues.
- Proficiency with orchestration platforms or logistics management systems a strong plus.
- Operationally focused and detail-oriented with strong project coordination skills.
- Able to lead in a high-paced, cross-functional environment while managing complex logistics workflows.
- Excellent written and verbal communication skills; clear and calm under pressure.
- Team-oriented mindset with a commitment to patient-first decision-making.