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Front Line Manufacturing Manager - Upstream Bulk Drug Substance - Days

BioSpace

Front Line Manufacturing Manager - Upstream Bulk Drug Substance - Days We are 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 8 am to 5 pm. 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 the 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 shift supporting 24/7 operations. What We Expect From You Doctorate 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. 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. What You Can Expect Of Us As we work to develop treatments that take care of others, we also care for our teammates’ professional and personal growth and well‑being. Benefits Annual base salary range for this U.S. opportunity is provided below. 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. 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. Apply now for a career that defies imagination. careers.amgen.com #J-18808-Ljbffr BioSpace

Vacancy posted 2 days ago
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