Front Line Manufacturing Manager Upstream Bulk Drug Substance Days

Front Line Manufacturing Manager - Upstream Bulk Drug Substance - Days

What you will do

Letsdo this.Letschange the world.Amgen is seeking a Manager ManufacturingUpstreamto provide frontline leadership supporting the facility expansion program and facility startup. Thisessentialrole will lead a team responsible for manufacturingcell cultureoperationsincluding seed train SUBs Perfusion RTF Stainless Steel BRXs Depth Filtration and Centrifugationwhile partnering across functions to ensure successful operational readiness technology transfer and rampup 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 thestartup you will be expected toworkaMonday Friday schedule from 8am 5pm.

This role may require work outside standard business hours including nonstandard 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 positionwillwork ona 12-hour 2-2-3 schedule from 5:45 am to6:15pmsupporting 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-hourshift 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 cGMPcompliant 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.

• CrossFunctional Collaboration:Partner with Quality Engineering NPI Supply Chain Validation and Site Leadership to enable successful startup and rampup.

• Compliance & Inspection Readiness:Maintaininspection readiness and adherence to regulatory and Amgen quality standards.

• Continuous Improvement:Identifyand drive efficiency reliability and scalability improvements as operations mature.

• Shift Support:Work nonstandard hours as transitioning to a 12hour 223 dayshift supporting 24/7 operations.

Win

What we expect from you

We are all different yet we all use our unique contributions to serve patients. Thebiotechnologyprofessional weseekis amanagerwith these qualifications.

Basic Qualifications

• Doctoratedegree OR

• Masters degreeand3years ofManufacturing or Operationsexperience OR

• Bachelors degree and5years ofManufacturing or Operationsexperience OR

• Associates degree and 10 years of ManufacturingorOperations experience OR

• High school diploma / GED and 12 years of ManufacturingorOperations experience

• AND Previous managerial experience directly managing people and/or experience leading teams projects programs or directing the allocation of resources