Front Line Manufacturing Manager - Upstream Bulk Drug Substance - Days

Front Line Manufacturing Manager - Upstream Bulk Drug Substance - Days

What you will do 

Let’s do this. Let’s change the world.  Amgen is seeking a Manager Manufacturing Upstream to provide frontline leadership supporting the facility expansion program and facility startup. This essential role will lead a team responsible for manufacturing cell culture operations including seed train, SUBs, Perfusion, RTF, Stainless Steel BRXs, Depth Filtration and Centrifugation, 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.  As Amgen relies upon the regular attendance of all staff members to meet legitimate business needs, the Manager must be able to work assigned 12-hour shift, including during inclement weather, some holidays and requested overtime in support of our operations.  

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 non‑standard hours as required, transitioning to a 12‑hour 2‑2‑3 day shift supporting 24/7 operations.

Win 

What we expect from you 

We are all different, yet we all use our unique contributions to serve patients. The biotechnology professional we seek is a manager with these qualifications. 

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