External Site Lead, Global External Manufacturing

Biogen seeks an External Site Lead to oversee Contract Development and Manufacturing Organization partnerships and manage pharmaceutical assembly, labeling, and packaging operations. The role requires technical expertise in process control, regulatory compliance, and supplier relationship management to ensure seamless manufacturing execution.

Responsibilities

• Manage CDMO partnerships and oversee manufacturing execution at external sites
• Provide technical oversight for assembly, labeling, and packaging operations
• Manage global change controls, deviations, and technology transfers
• Analyze scientific datasets and develop process control strategies
• Lead continuous improvement initiatives and drive business process optimization

Requirements

• Bachelor's degree in Engineering or related field
• Minimum 7 years of experience in operations or manufacturing
• Expertise in device assembly and label/packaging processes
• Knowledge of cGMP, FDA/EMA regulations, and process qualification
• Experience managing CDMO contracts and supplier relationships
• Project management and cross-functional team leadership skills
• Strong analytical and written communication abilities

Compensation: $142,000–$190,000 base