External Site Lead

Summary

Join Biogen's Global External Manufacturing team as an External Site Lead, overseeing CDMO sites and ensuring operational efficiency. Lead technical and manufacturing execution at external supplier sites, analyze scientific data, manage technology transfers, and solve complex manufacturing issues. Drive continuous improvement initiatives, collaborate with cross-functional teams, and manage external relationships. This remote position requires a Bachelor's degree and 10+ years of experience in a related field, along with expertise in CDMO management and cGMP regulations. Biogen offers a competitive salary, LTI grants, and a full range of benefits.

Requirements

• Bachelor's degree in a related field with a minimum of 10 years of experience
• Equivalent experience equates to a Masters and 8 years of experience or a PhD and 5 years of experience
• Technical subject matter expertise corresponding to the manufacturing site designation (emphasis on oral solid dose drug products)
• Experience across Operations and Supplier Relationship Management roles
• Proven track record of successful CDMO relationship management and governance execution
• Solid technical understanding of process control strategies for specific modalities and/or nodes
• Strong analytical, written, communication, and project management skills
• Proficiency in resolving complex technical project management issues in compliance with regulatory expectations and business procedures
• Knowledge of cGMP, FDA/EMA regulations, and Process Performance Qualification
• Expertise in analyzing scientific data sets and managing technical operations
• Demonstrated ability to drive continuous improvement in a commercial manufacturing environment

Responsibilities

• 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

Benefits

• Medical, dental, life, long and short-term disability insurances
• Vacation
• End-of-year shutdown
• 401K participation and matching contributions
• LTI grants
• Other incentive programs