Front Line Manufacturing Manager (Bulk Drug Substance - Downstream) - Day Shift

Manager Manufacturing (Downstream) – Day Shift Lead frontline manufacturing operations for GMP drug substances in a 12‑hour 2‑2‑3 shift schedule (5:45am–6:15pm). Oversee 24/7 production with an emphasis on safety, quality, and continuous improvement. Responsibilities Supervise manufacturing associates in GMP drug substance production. Champion a safe and compliant production environment. Embed Lean and continuous‑improvement principles on the floor. Support staff development through coaching, hiring, mentorship, and training plans. Define area objectives, identify improvement opportunities, and lead change efforts. Ensure compliance with cGMP, CFR, ISO, and internal regulatory and QA change‑control procedures. Ensure proper gowning and aseptic techniques; maintain gowning training programs. Interact with regulatory agencies and notify QA prior to changes. Demonstrate technical mastery of manufacturing processes. Collaborate with cross‑functional teams (QA/QC, F&E, PPIC, Mfg, PD, Regulatory, etc.) to complete production activities. Develop, implement, and assess CAPAs and solve complex problems. Oversee set up, execution, and completion of critical manufacturing processes/tasks. Assist in planning, developing, and maintaining budgets; contribute to departmental goals. 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 resource allocation. Preferred Qualifications Bachelor’s degree in Life Sciences or Engineering. Strong leadership skills and technical understanding of biotechnology production operations. Experience in biotechnology or pharmaceutical plant start‑up. Understanding of downstream purification operations (column chromatography, TFF, viral filtration, viral inactivation). Previous cGMP knowledge and 5+ years process experience in a cGMP manufacturing facility. 3+ years of experience in a production Area Lead, Specialist or Manager role. Strong team‑building skills (coaching, mentoring, counseling). Experience with performance management, conflict resolution, analytical problem solving, and project management skills. Thorough understanding of regulatory requirements. Excellent verbal and written communication (technical) skills. Excellent computer skills with Microsoft, EBR/MES, DeltaV, Electronic quality systems. Benefits Annual base salary range: $106,148–$143,612. Total Rewards Plan includes health and welfare plans, a retirement and savings plan, group medical, dental and vision coverage, life and disability insurance, flexible spending accounts, discretionary annual bonus, long‑term equity incentives, time‑off plans, and flexible work models including remote work where possible. #J-18808-Ljbffr Amgen Inc. (IR)