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Amgen is seeking a Manager Manufacturing Downstream to provide frontline leadership supporting the facility expansion program and facility startup. This essential role will lead a team responsible for manufacturing downstream purification operations including column packing, column chromatography, TFF, viral filtration, viral inactivation, conjugation, and final fill while partnering across functions to ensure successful operational readiness, technology transfer, and ramp-up of manufacturing operations within the new facility. The Manager will play a critical role supporting the design, build, startup, and operational phases of the facility expansion. The position will initially focus on facility startup and operational readiness activities, transitioning to manufacturing leadership as the facility becomes operational. During this phase of the startup, you will be expected to work a Monday – Friday schedule from 8am – 5pm. This role may require work outside standard business hours, including non-standard shifts, as needed to support startup, commissioning and qualification (C&Q), and engineering execution. As the business moves from C&Q to manufacturing operations, this essential position will work on a 12-hour 2-2-3 schedule from 5:45 am to 6:15pm supporting our critical 24/7 manufacturing operations.
Job Responsibility
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 ramp-up
Maintain inspection readiness and adherence to regulatory and Amgen quality standards
Identify and drive efficiency, reliability, and scalability improvements as operations mature
Work non-standard hours as required, transitioning to a 12-hour 2-2-3 dayshift supporting 24/7 operations
Requirements
Doctorate degree OR Master's degree and 3 years of Manufacturing or Operations experience OR Bachelor's degree and 5 years of Manufacturing or Operations experience OR Associate's degree and 10 years of Manufacturing or Operations experience OR High school diploma / GED and 12 years of Manufacturing or Operations experience
Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources
Nice to have
Bachelor's degree in Life Sciences or Engineering
Experience with facility startup, commissioning, or operational readiness
Biologics / drug substance manufacturing experience (downstream)
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
What we offer
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