Sr. Manager of Global Manufacturing - Taipei, 台湾 - Fyte

描述

• Actively participate in developing and executing strategies and timelines to ensure the successful launch of clinical or commercial products.
• This involves overseeing Contract Manufacturing Organizations (CMOs), establishing manufacturing strategies, setting priorities, and forecasting activities that influence overall drug requirements.
• Implement serialization for commercial manufacturing to adhere to regulations and ensure product traceability. Collaborate with Supply Chain, CMC, Research and Development, Quality Assurance, Procurement, and PMO teams to ensure timely implementation.
• Provide comprehensive oversight of manufacturing activities and ensure readiness for all products. Facilitate technical transfer to CMOs for manufacturing drugs to meet clinical and commercial demands.
• Demonstrate exceptional troubleshooting skills to address any issues affecting product timeline completion and accuracy.
• Globally manage CMOs, including regular and emergency production of Drug Substance Intermediate (DSI), Drug Substance (DS), and Drug Product (DP) to meet target timelines.
• Collaborate with various cross-functional departments to furnish necessary information and advance project progress.
• Execute project management duties, overseeing both routine and emergency production of DSI, DS, and DP. Manage equipment maintenance and procure necessary materials.
• Effectively manage budgets, overseeing payment and invoice processes for all CMOs.
• Fulfill assigned tasks as directed by the supervisor.

• BS or MS degree in pharmaceutical science, microbiology, immunology, chemistry, or other related fields. Fluent in both English and Mandarin.
• Knowledge of drug substances (DS)/drug products(DP)/antibody-drug conjugate(ADC) is a plus. At least 8 years of DS/DP/ADC production experience in a GMP pharmaceutical production plant.
• Demonstrated communication skills in project management and CMO vendor management.
• Proficiency in spreadsheets, ERP systems, and project management software.
• Working knowledge of current GMP guidance.
• Demonstrate initiative and priority to function effectively in a fast-paced environment.