External Site Lead for Global CDMO Manufacturing

Biogen; Cambridge (MA); Sur place; USD 142 000 - 190 000; Plein temps

Avantages offerts par ce poste

Medical insurance

Dental insurance

Vision insurance

Life insurance

Fitness reimbursement

Disability insurance

Paid vacation

Paid holidays

401(k) matching

Employee stock purchase plan

Tuition reimbursement

Résumé du poste

Biogen seeks an External Site Lead to oversee CDMO relationships and manufacturing execution, ensuring compliance and continuous improvement across external sites. You will manage change controls, drive technology transfers, and analyze datasets to support robust process control strategies.

The role requires strong leadership, cross-functional collaboration, and expert knowledge of cGMP and regulatory requirements, with direct vendor governance responsibilities and a focus on delivering

Qualifications

• Bachelor’s degree in related field, engineering, and 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.
• Project management and cross-functional team leadership.
• Strong analytical and written skills for informed decisions.

Responsabilités

• 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 CPV reports.
• Develop 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 monitor performance.

Connaissances

CDMO management

Device assembly

Label & packaging

Operations experience

Supplier relationship management

cGMP knowledge

FDA/EMA regulations

Project management

Communication skills

Analytical writing

Formation

Bachelor’s degree in Engineering

Description du poste

Biogen seeks an External Site Lead to oversee CDMO relationships and manufacturing execution, ensuring compliance and continuous improvement across external sites. You will manage change controls, drive technology transfers, and analyze datasets to support robust process control strategies.

The role requires strong leadership, cross-functional collaboration, and expert knowledge of cGMP and regulatory requirements, with direct vendor governance responsibilities and a focus on delivering