Global External Manufacturing Site Lead - CDMO Partnerships

Biogen, Inc.; Cambridge (MA); On-site; USD 142,000 - 190,000; Full time

Benefits offered by this job

Medical, Dental, Vision, & Life ins.

Fitness & Wellness programs

Paid vacation & holidays

Job summary

Biogen seeks an External Site Lead to oversee CDMO partnerships, drive manufacturing execution, and ensure robust process controls at external sites. You will manage change controls, technology transfers, and CPV activities while coordinating cross-functional teams across geographies.

You bring 7+ years in device assembly/packaging, CDMO governance, and strong project-management skills to optimize quality, cost, and delivery of biologics manufacturing.

Qualifications

• Bachelor’s degree in related field, preferably in Engineering discipline, and a minimum of 7 years of experience.
• Expertise in device assembly and/or label and packaging.
• Experience in Operations or Supplier Relationship Management.
• Knowledge of cGMP, FDA/EMA regulations, and Process Performance Qualification.
• Expertise in external CDMO management, governance, contracting, and relationship management.
• Proficiency in project management and communication skills for leading cross-functional teams.
• Strong analytical and written skills, with the ability to drive impactful decisions.

Responsibilities

• Manage and oversee CDMO relationships with a focus on manufacturing execution.
• Provide technical and operational oversight for assembly, label and pack.
• Manage global change controls and deviations effectively.
• Drive, manage, and deliver technology transfers.
• Analyze scientific datasets to ensure robust process control strategies.
• Author and review site-specific Continuous Process Verification (CPV) reports.
• Develop and implement corrective actions and drive business process optimization.
• Lead continuous improvement initiatives to enhance efficiency, quality, and cost-effectiveness.
• Manage supplier relationship activities from contract negotiation to execution.
• Conduct business performance reviews and manage partner governance.
• Act as a primary engagement leader and actively monitor performance.

Skills

Device assembly

Label & packaging

CDMO management

Contracting

Relationship management

Project management

Communication

Analytical

Written skills

Education

Bachelor's degree in Engineering

Job description

Biogen seeks an External Site Lead to oversee CDMO partnerships, drive manufacturing execution, and ensure robust process controls at external sites. You will manage change controls, technology transfers, and CPV activities while coordinating cross-functional teams across geographies.

You bring 7+ years in device assembly/packaging, CDMO governance, and strong project-management skills to optimize quality, cost, and delivery of biologics manufacturing.