Miragen Therapeutics (NASDAQ: MGEN) is a publicly traded clinical-stage biopharmaceutical company discovering and developing proprietary RNA-targeted therapeutics with a specific focus on microRNAs and their roles in diseases where there is a high unmet medical need.
We currently seek an experienced Clinical Supply Manager to support corporate and clinical milestones through effective supply chain management. The incumbent will have primary oversight of all clinical supply logistics and lead full-cycle clinical supply activities. Primary responsibilities include:
• Work with key functional groups including Program Management, Clinical, CMC, Quality, and Regulatory to identify IP demand and develop and maintain a comprehensive clinical supply chain forecast/plan.
• Coordinate and manage supply chain services including but not limited to labeling, filling, inventory control, shipping, and global import/export licensing.
• Implement an IWRS or IVRS, set-up design specifications, and provide basic training.
• Ensure all required documentation is transferred to Quality/Master File.
• Monitor inventory levels at clinical sites through the life of the trial; take preventative actions to recognize and avoid potential supply issues.
• Request, review, and approve proposals from CMO/CRO.
• Work with Finance and Clinical Outsourcing to track and manage invoices.
• Manage and track inventory and storage of drug intermediates.
• Develop plans for commercializing supply chain activities.
• A Bachelor’s degree and minimum 8 years of experience in the biopharma industry with 3 years minimum experience in clinical supply management. Global supply chain management is preferred.
• Experience developing and simultaneously managing multiple comprehensive drug supply plans.
• Demonstrated knowledge in CRO/CMO management, including labeling, packaging, and global distribution.
• Solid understanding of cGMP’s and relevant FDA and EU Regulations.
• Comprehensive understanding of the drug development/commercialization process.
• Highly organized, good time-management and the ability to handle shifting priorities while maintaining accuracy and quality.
• Strong analytical and critical thinking abilities.
• Travel required (15%-20%)