Front Line Manufacturing Manager - Downstream Bulk Drug Substance - Days

About the role

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.

Schedule

• During the startup phase: Monday–Friday, 8am–5pm, with work outside standard business hours including nonstandard shifts as needed to support startup, commissioning and qualification (C&Q), and engineering execution
• Transitioning to manufacturing operations: 12-hour 2-2-3 schedule, 5:45 am to 6:15 pm, supporting 24/7 manufacturing operations
• Must be able to work assigned 12-hour shift, including during inclement weather, some holidays, and requested overtime

Responsibilities

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

Basic Qualifications

• 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
• And previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources

Preferred Qualifications

• 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

Benefits

• Comprehensive employee benefits package including group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• Retirement and Savings Plan with generous company contributions
• Discretionary annual bonus program
• 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