Front Line Manufacturing Manager (Bulk Drug Substance - Upstream) - Night Shift

Amgen seeks a Manufacturing Manager for upstream bulk drug substance production at its advanced Holly Springs facility. The night-shift (2-2-3 rotation) front-line manager will lead experienced manufacturing associates in GMP operations, ensuring compliance, staff development, and continuous improvement in a highly regulated biotechnology environment.

Responsibilities

• Lead on-shift front-line manufacturing operations and supervise team of manufacturing associates
• Ensure compliance with cGMP, CFR, and Amgen policies; manage change controls and regulatory interactions
• Select, train, evaluate, and develop floor staff; mentor team members on Amgen values
• Identify improvement opportunities, implement process optimizations, and resolve complex operational problems
• Oversee setup, execution, and completion of critical manufacturing processes and production schedules

Requirements

• Bachelor's degree in life sciences or engineering, or equivalent education with 5+ years manufacturing experience
• Previous managerial experience directly managing people or leading teams and projects
• Strong technical understanding of biotechnology production and upstream operations
• Knowledge of cGMP regulations, CFR compliance, and highly regulated manufacturing environments
• Leadership and teambuilding skills including coaching, mentoring, and performance management
• Analytical problem-solving and project management capabilities
• Proficiency with Microsoft Office and manufacturing systems (EBR/MES, Delta V, electronic quality systems)