Front Line Manufacturing Manager - Downstream Bulk Drug Substance - Days

Front Line Manufacturing Manager – Downstream Bulk Drug Substance – Days Front-line leadership for a new manufacturing facility, focusing initially on startup and operational readiness, then transitioning to full manufacturing operations. Responsibilities Lead, develop, and coach a manufacturing team; set clear performance expectations; foster a culture of safety, quality, and accountability. Support design, build, commissioning, qualification (C&Q), staffing, training, and readiness milestones for a new manufacturing facility. Ensure safe, cGMP‑compliant execution; drive performance across safety, quality, schedule, and cost; resolve deviations and operational issues. Support transfer and implementation of manufacturing processes; ensure manufacturability, troubleshooting, and continuous improvement. Partner with Quality, Engineering, NPI, Supply Chain, Validation, and Site Leadership to enable successful startup and ramp‑up. Maintain inspection readiness and adherence to regulatory and Amgen quality standards. Identify and drive efficiency, reliability, and scalability improvements as operations mature. Work non‑standard hours as required, transitioning to a 12‑hour 2‑2‑3 day shift supporting 24/7 operations. Qualifications Basic Qualifications: Doctorate degree OR 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 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 Competitive base salary (US$106,148.00 – 143,612.00) Comprehensive employee benefits package, including retirement and savings plans, medical, dental, vision, life, and disability insurance, and flexible spending accounts Discretionary annual bonus program and long‑term equity incentives Generous time‑off plans, bi‑annual company‑wide shutdowns, and flexible work models such as remote work arrangements where possible Career development opportunities and training programs to support professional growth Salary Range US$106,148.00–143,612.00 per year. #J-18808-Ljbffr