Front Line Manufacturing Manager (Bulk Drug Substance - Downstream) - NightShift

Amgen; Holly Springs (NC); On-site; USD 140,000 - 170,000; Full time

Job summary

Amgen seeks a Front Line Manufacturing Manager for night shift operations at its Holly Springs, North Carolina facility. The role oversees manufacturing teams on a 12-hour rotating schedule, ensuring GMP compliance and safe production practices.

The manager will drive continuous improvement, recruit and develop staff, and collaborate with cross-functional teams on CAPA and process execution to meet production schedules.

Qualifications

• Minimum 5+ years of process experience in a cGMP manufacturing facility.
• Experience leading teams and projects.
• Bachelor's degree in Life Sciences or Engineering preferred.

Responsibilities

• Oversee manufacturing teams on 12-hour night shift rotation producing GMP drug substances.
• Champion safe, compliant production environment and lead continuous improvement initiatives.
• Recruit, train, coach, develop and evaluate staff; ensure adherence to production schedules.
• Collaborate with cross-functional teams on process execution, problem solving, and CAPA development.
• Ensure regulatory compliance, proper gowning/aseptic techniques, and workplace safety standards.

Skills

Leadership

Coaching

Team building

Regulatory compliance

cGMP

Problem solving

Education

Bachelor's degree in Life Sciences or Engineering

Job description

Amgen seeks a Front Line Manufacturing Manager for night shift operations at its advanced drug substance facility in Holly Springs, North Carolina. This role involves overseeing manufacturing teams on a 12-hour rotating schedule, ensuring GMP compliance, driving continuous improvement, and developing staff while maintaining safe, efficient production operations.

Responsibilities

• Oversee manufacturing teams on 12-hour night shift rotation producing GMP drug substances
• Champion safe, compliant production environment and lead continuous improvement initiatives
• Recruit, train, coach, develop and evaluate staff; ensure adherence to production schedules
• Collaborate with cross-functional teams on process execution, problem-solving, and CAPA development
• Ensure regulatory compliance, proper gowning/aseptic techniques, and workplace safety standards

Requirements

• Previous managerial experience directly managing people or leading teams and projects
• Bachelor's degree in Life Sciences or Engineering preferred
• 5+ years process experience in cGMP manufacturing facility preferred
• 3+ years experience in production Area Lead, Specialist, or Manager role preferred
• Strong leadership, coaching, mentoring, and team-building skills
• Understanding of downstream purification operations and cGMP/CFR regulatory compliance