Denali Therapeutics - South San Francisco, CA
posted 3 months ago
Denali Therapeutics is seeking a Manager for the Clinical Supply Chain to join our team in South San Francisco. This role is pivotal in ensuring the effective production and distribution of therapies aimed at treating neurodegenerative diseases, which represent one of the most significant medical challenges today. As a biotechnology company, Denali is dedicated to developing breakthrough therapies through a deep commitment to degeneration biology and translational medicine. The successful candidate will work closely with the Clinical Supply Chain Planning Lead to monitor and enhance production and distribution strategies for various clinical programs. In this position, you will serve as the primary point of contact for Supply Chain Execution, collaborating with internal stakeholders such as Supply Chain, Quality Assurance (QA), and Clinical Operations. You will oversee Denali's Finished Product supply chain vendors, facilitating execution activities that include contracts, product setup, labeling, packaging, distribution, and inventory management. Your responsibilities will also encompass facilitating label development, approval, and tracking, as well as managing the issuance and tracking of QP Declaration and Certification. Additionally, you will document and execute IRT transactions necessary for the release and distribution of products through the clinical supply chain. Investigating exceptions to determine root causes, implementing Corrective and Preventive Actions (CAPAs), and driving closure will be key aspects of your role. You will proactively identify and troubleshoot issues to prevent missed timelines and communicate the status of supply execution activities through both verbal and written reports. Continuous operational performance improvement efforts will be a focus, and you will participate in supply chain business process development projects to enhance efficiency and effectiveness.