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Front Line Manufacturing Manager - Upstream Bulk Drug Substance - Days

Amgen SA

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 6:15 pm 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. Basic Qualifications Doctorate degree Master’s degree and 3 years of Manufacturing or Operations experience Bachelor’s degree and 5 years of Manufacturing or Operations experience Associate’s degree and 10 years of Manufacturing or Operations experience High school diploma / GED and 12 years of Manufacturing or Operations experience Previous managerial experience directly managing people and/or 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 (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 Benefits The annual base salary range for this opportunity 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. 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 #J-18808-Ljbffr Amgen SA

Vacancy posted 3 days ago
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