Front Line Manufacturing Manager - Upstream Bulk Drug Substance

About the role

Amgen is seeking a Front Line Manufacturing Manager for its upstream bulk drug substance manufacturing in North Carolina, a new facility that is starting up. The manager provides frontline leadership for cell culture operations (seed train, SUBs, perfusion, RTF, stainless steel BRXs, depth filtration and centrifugation) and partners with Quality, Engineering, NPI, Supply Chain, Validation and Site Leadership to support design, build, startup, commissioning and qualification (C&Q), and ramp-up. The role begins with startup and operational readiness, then transitions to manufacturing leadership.

Key responsibilities

• Lead, develop and coach a manufacturing team, set performance expectations and foster a culture of safety, quality and accountability
• Support facility startup, commissioning, qualification, staffing, training and readiness milestones
• Ensure safe, cGMP-compliant execution and drive performance on safety, quality, schedule and cost
• Resolve deviations and operational issues, and support technology transfer and process implementation
• Maintain inspection readiness and adherence to regulatory and quality standards
• Drive continuous improvement as operations mature
• Work non-standard hours, including a Monday-Friday 8am-5pm schedule initially, then a 12-hour 2-2-3 shift for 24/7 operations, including overtime and holidays

Required profile

• Doctorate or Master's degree with 3 years of manufacturing or operations experience, or Bachelor's with 5 years, or Associate's with 10 years, or high school diploma with 12 years
• Previous managerial experience leading people, teams, projects or programs
• Preferred: Bachelor's in Life Sciences or Engineering, biologics/drug substance manufacturing experience, cGMP experience (5+ years preferred), technology transfer experience, prior area lead/specialist/manager experience, and strong leadership and conflict-resolution skills

Required skills

• Preferred: proficiency with MES/EBR, DeltaV, Maximo, Veeva, LIMS and electronic quality systems
• Solid understanding of regulatory requirements

What we offer

• Annual base salary range of $106,148 to $143,612
• Total rewards: health, dental and vision coverage, life and disability insurance, retirement savings plan with company contributions, and a discretionary annual bonus or sales-based incentive plan
• Stock-based long-term incentives, time-off plans and bi-annual shutdowns
• Flexible work models, including remote work where possible