Manager, Clinical Supply Chain

Role Summary

Manager of Clinical Supply Chain responsible for managing GMP inventory and global logistics at Viking’s San Diego site. Cross-functional role working with Quality Control, Quality Assurance, CMC, development, regulatory, and external vendors to define and operationalize the Supply Chain system and support clinical material manufacturing globally from pre-IND through post-launch.

Responsibilities

• With minimal supervision, manage and support investigational drug product supply and logistics activities, including demand forecasting and supply planning, IRT start-up and maintenance, label generation and approval, packaging and labeling operations, release and distribution, expiry extension, returns, reconciliation, destruction, cold chain management, and inventory management
• Monitor inventory levels ensuring no shortage of IMP throughout the life of a clinical trial
• Manage packaging and labeling/distribution vendors, including relationship management
• Prepare clinical trial pharmacy manuals, packaging methods, batch records, drug labels, shipping documents, destruction certification, coordinating origination, proofing, and translation of clinical study labels
• Proactively identify potential issues and develop mitigating actions
• Interpret clinical synopses and protocols to create clinical IMP demand forecasts
• Attend clinical study and cross-functional meetings as needed
• Oversee the execution of multiple clinical trials and proactively identify potential supply chain issues and recommend solutions
• Manage clinical study close-out activities, including returned goods, reconciliation, and inventory destruction
• Support drug supply delivery through coordination of CMC efforts with related functions
• Support temperature excursion processes as required
• Support IRT System development and lead development of user requirement specifications
• Various other duties as assigned

Qualifications

• Bachelor’s degree in Chemistry, Pharmacy or other relevant discipline
• 6+ years of industry experience in Supply Chain Operations
• Significant experience with global shipping and logistics of materials
• Experience working in an FDA-regulated environment
• Experience with GMP quality-controlled storage
• Direct experience with importing/exporting documentation for global distribution of live virus banks, cell banks, and raw materials
• Direct experience with 3rd party vendors for shipping/logistics service
• Knowledge of cGxP and regulatory requirements for the pharmaceutical industry
• Experience reviewing and authoring SOPs related to CMC Clinical supply chain
• Experience organizing and managing GMP warehouse inventory in biotech/pharma/consumer goods
• Experience with Inventory Management Systems is a plus
• Technical knowledge/experience in product packaging or design is a plus
• Ability to thrive in a fast-paced, dynamic environment with changing priorities
• Strong computer skills with Microsoft Office and ability to learn new applications quickly
• Team player with strong communication and interpersonal skills, able to build relationships at all organizational levels