About This Role:
As an External Site Lead on our Global External Manufacturing team, you are a functional leader who brings specialized knowledge and deep expertise in pharmaceutical and biologics manufacturing. Your primary responsibility will be to oversee intermediate complexity CDMO sites, ensuring operational efficiency while minimizing the need for frequent intensive care. Your role is critical in analyzing scientific data sets, managing process controls, and executing manufacturing operations at external supplier sites. With a focus on continuous process verification and improvement, you will enhance the efficiency, quality, and cost-effectiveness of manufacturing operations. Reporting to the General Manager - Americas, your technical and manufacturing leadership will drive the achievement of key goals, adding significant value to our business and integrating seamlessly into our overall business structure.This is a remote position and candidate can be located anywhere in the United States.What You’ll Do:Lead the technical and manufacturing execution for specific modalities and/or manufacturing nodes at external supplier sites.Analyze scientific datasets and provide oversight towards manufacturing operations, including global change controls and deviations.Manage technology transfer deliverables, project metrics, and author site-specific Continuous Process Verification (CPV) reports.Solve complex manufacturing and compliance issues and develop and implement corrective actions (CAPAs).Identify and lead business process optimization opportunities, driving them towards implementation.Collaborate with senior leadership and cross-functional teams to ensure alignment and delivery of manufacturing objectives.Lead continuous improvement initiatives aimed at enhancing operational efficiency, quality, and cost-effectiveness.Manage external relationship management expertise, including CDMO and/or CLO engagement from site selection through contract negotiation and performance reviews.Drive and monitor supplier performance, ensuring compliance with Biogen procedures and cGXP regulations.Own the vendor team engagement, partnering with the General Manager for governance execution.