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Position Overview:

This is a great opportunity to join a small team with big ideas where we are building a Supply Chain and External Manufacturing organization from the ground up. We are seeking an Associate Director of Clinical Supply Chain who will be responsible for creating and overseeing clinical supply chain operations and developing robust risk-based materials operations capabilities that are stage appropriate and scale-able to reliably supply product and key materials and reagents to our stakeholders as we progress programs through pre-clinical and clinical phases. In support of our lead program featuring an ex vivo autologous prime edited cell therapy, the candidate will be responsible for the creation and implementation of our shipping/logistics/tracking processes and procedures including Chain of Custody (COC) and Chain of Identity (COI). This critical role will report directly to the Head of External Manufacturing and Supply Chain and will interface with the Program Team, CMC team, QA, QC, External Manufacturing, Clinical Operations, and key Strategic Vendors to ensure supply to patients. The incumbent must have strong interpersonal skills, excellent project management and coordination skills, ability to influence without authority and to gain trust and credibility quickly.

Join our team and be a pioneer – build something great!

Responsibilities:

• This is a hands-on role, owning the development and implementation of autologous cell supply chain build out and detailed functionality including:

• Apheresis scheduling and coordination with contract shippers and manufacturers; establishing pack-out instructions; shipping validation; label creation and management.
• Work with cross-functional team to establish requirements for apheresis and drug product labeling.
• Develop and implement traceability through COI and COC procedures and necessary forms; lead vendor selection and implementation of tracking system as appropriate.
• Draft appropriate documentation such as SOPs and technical documents with support of SMEs.
• Storage and shipping strategy prior to administration following release of product.
• Coordinating and scheduling of shipments back to clinical site
• Courier and cold chain shipper management including shipper pack-out, coordinating pickup, temperature confirmation, delivery confirmation and instructions for product removal, shipper return management.
• Collaborate with External Quality to resolve deviations and temperature excursions that may arise
• Owns cross-functional communication and visibility of the product journey for each patient
• Draft and deliver training to both internal team members and external personnel at site and contract vendors.
• Develop and execute mock run(s) to validate supply chain processes, clinical site readiness, and work instructions.

• Manage overall supply chain timeline ensuring alignment with CMC milestones for each Program.
• Build and maintain a comprehensive understanding of critical inventory of non-GMP and GMP materials within the supply chain for all Programs. As part of this understanding, execute a supply chain materials risk assessment and develop mitigation strategies for top risks.
• Identify, escalate, and mitigate critical risks impacting raw material availability, production plan alignment, timelines and ultimately supply of product(s) to the Program(s).
• Responsible for supply chain budget and interacting with finance.
• Assess resources and ensure staffed appropriately for success through either head-count request or engaging contractor support.
• Team mindset - willing to contribute to do what it takes to ensure delivery of patient cells, and to pitch in when others need help, as well as willingness to ask for assistance, as needed.

Qualifications:

• Bachelor’s Degree in a relevant field and 10+ years’ experience in supply chain; planning C&GT products and experience building an autologous cell and gene therapy supply chain strongly preferred.
• Experience developing, building out and implementing supply planning and shipping/logistics infrastructure for an autologous cell product.
• Familiar with other delivery modalities (LNP, AAV, etc.)
• Global experience familiar with shipping regulations, import/export of products, trade compliance
• Highly independent role; able to navigate ambiguity and gain consensus from colleagues and leadership with minimal oversight.
• Ability to manage complex logistical considerations, proactively identify risks and troubleshoot issues to ensure proper supply chain and traceability elements are maintained.
• Experience coordinating with contract manufacturing organizations and couriers required.
• Experience in supply chain handling, clinical manufacturing, distribution and patient operations including knowledge of COI and COC.
• Knowledge of cGMP and GCP requirements.
• Strong communication skills (written and verbal), including experience presenting in front of multidisciplinary stakeholders and senior management.
• Strong leadership skills, including a demonstrated ability to lead cross-functional teams and negotiate with both internal and external partners.
• Ability to act in a complex and rapidly changing business environment.