External Site Lead, Global External Manufacturing

Bachelor's degree in a related field with a minimum of 10 years of experience, or equivalent experience. Technical subject matter expertise in manufacturing, especially oral solid dose drug products. Experience in Operations and Supplier Relationship Management roles. Proven success in CDMO relationship management and governance execution. Solid technical understanding of process control strategies. Strong analytical, written, communication, and project management skills. Knowledge of cGMP, FDA/EMA regulations, and Process Performance Qualification.

Lead technical and manufacturing execution for specific modalities and manufacturing nodes at external supplier sites. Analyze scientific datasets and provide oversight towards manufacturing operations, including global change controls. Manage technology transfer deliverables, project metrics, and Continuous Process Verification reports. Solve complex manufacturing and compliance issues, developing and implementing corrective actions. Identify and lead business process optimization opportunities. Collaborate with senior leadership and cross-functional teams to align manufacturing objectives. Drive and monitor supplier performance, ensuring compliance with regulations.