Associate Director, Supply Chain Operations

Role Summary

Associate Director, Supply Chain Operations

In this role, you'll own the development and management of the clinical supply chain for Arcellx’s cell therapy pipeline and work closely with cross-functional partners in our clinical development and operations, manufacturing, QA, and regulatory to ensure timely and compliant supply of clinical trial materials (CTM).

Responsibilities

• Develop and implement comprehensive supply chain strategies.
• Conduct robust demand forecasting, inventory management, and production scheduling to optimize resource utilization.
• Oversee all operational aspects of the clinical supply chain.
• Review clinical protocols and design appropriate supply chain strategies.
• Work with the clinical team to configure, set up and maintain Interactive Response Technology (IRT) Systems.
• Develop global SOPs and processes for trial materials.
• Solve study/project level technical and business issues of trial materials.
• Oversee packaging and labeling activities for clinical trial materials in compliance with Good Manufacturing Practices (GMP).
• Build and maintain strong partnerships with external vendors.
• Negotiate contracts, ensure compliance with quality standards, and drive continuous improvement in vendor performance.
• Design and develop clinical supply plans and distribution instructions with clinical supply chain vendors.
• Proactively identify, assess, and mitigate potential risks within the clinical supply chain, including supply chain disruptions, forecasting inaccuracies, and regulatory challenges.
• Ensure all supply chain activities adhere to regulatory requirements and maintain comprehensive documentation.
• Develop and manage budgets for clinical supply chain operations.
• Continuously evaluate and optimize supply chain processes, systems, and technologies to enhance efficiency, scalability, and flexibility.
• Drive process improvement initiatives to streamline operations, reduce costs, and improve overall supply chain performance.

Qualifications

• 8+ years of experience in supply chain in the pharmaceutical/biotechnology industry.
• Demonstrated history working through ambiguity in a start-up environment where building while operating is the norm.
• Strong command of the knowledge and skills needed for success in the role, such as IRT, GCP, GMP, GDP and ERP systems.
• High attention to detail with demonstrated experience in process ownership and compliance. Process improvement and change management experience is required.
• Demonstrated organizational and planning skills.
• Must act with integrity, be customer-centric and results-oriented.
• Strong communications skills with excellent interpersonal and collaboration abilities.