Front Line Manufacturing Manager - Upstream Bulk Drug Substance - Days

Responsibilities

• Lead, develop, and coach a manufacturing team; set clear performance expectations; foster a strong culture of safety, quality, and accountability.
• Support design, build, commissioning, qualification (C&Q), staffing, training, and readiness milestones for a new manufacturing facility.
• Ensure safe, cGMP compliant execution; drive performance across safety, quality, schedule, and cost; resolve deviations and operational issues.
• Support transfer and implementation of manufacturing processes; ensure manufacturability, troubleshooting, and continuous improvement.
• Partner with Quality, Engineering, NPI, Supply Chain, Validation, and Site Leadership to enable successful startup and rampup.
• Maintain inspection readiness and adherence to regulatory and Amgen quality standards.
• Identify and drive efficiency, reliability, and scalability improvements as operations mature.
• Work nonstandard hours as required, transitioning to a 12-hour 2-2-3 day shift supporting 24/7 operations.

Requirements

• Doctorate degree OR Masters degree and 3 years of Manufacturing or Operation experience OR Bachelors degree and 5 years of Manufacturing or Operation experience OR Associates degree and 10 years of Manufacturing or Operations experience OR High school diploma/GED and 12 years of Manufacturing or Operations experience AND Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources.
• Bachelors degree in Life Sciences or Engineering Experience with facility startup, commissioning, or operational readiness Biologics / drug substance manufacturing experience (Upstream) cGMP manufacturing experience (5+ years preferred).
• Experience with technology transfer and process implementation Prior Area Lead / Specialist / Manager experience Strong leadership, performance management, and conflict resolution skills Solid understanding of regulatory requirements Proficiency with MES/EBR, DeltaV, Maximo, Veeva, LIMS, and electronic quality systems.

Qualifications

• Bachelor's degree in Life Sciences or Engineering
• Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources
• Experience with facility startup, commissioning, or operational readiness
• Biologics / drug substance manufacturing experience (Upstream)
• cGMP manufacturing experience (5+ years preferred)
• Experience with technology transfer and process implementation
• Prior Area Lead / Specialist / Manager experience
• Strong leadership, performance management, and conflict resolution skills
• Solid understanding of regulatory requirements
• Proficiency with MES/EBR, DeltaV, Maximo, Veeva, LIMS, and electronic quality systems

Skills

• Leadership
• Performance Management
• Conflict Resolution
• Regulatory Compliance
• Facility Startup
• Technology Transfer
• Process Implementation
• Collaboration

Benefits

Annual base salary range in the U.S. is provided below. In addition to the base salary, Amgen offers a total rewards plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan Stock-based long-term incentives Award-winning time-off plans and bi-annual company-wide shutdowns Flexible work models, including remote work arrangements, where possible.