Manager Manufacturing Environmental and Contamination Control

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas – Oncology, Inflammation, General Medicine, and Rare Disease – we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity‑related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller, happier lives. Our award‑winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lie within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Manager Manufacturing Environmental & Contamination Control What You Will Do In this vital role you will be responsible for day‑to‑day delivery of deviation records and investigations, ensuring Deviation Owners and FAOs execute with rigor, speed, and compliance, particularly for microbial and EM‑related events. This role shall report to the Senior Manager of the Environmental and Contamination Control (ECC) team. Responsibilities Direct Management of Deviation Owners & FAO’s Lead and coordinate: Deviation Owners (execution) Process Specialists (technical oversight) Ensure clear ownership assignment and appropriate planning and distribution of workload Ensure timely movement of records Oversee Deviation Lifecycle: Initiation → triage → investigation → closure Ensure records are complete, accurate, and audit‑ready Remove barriers to timely closure and escalation Ensure robust root cause analysis (RCA) and appropriate scoping and impact assessment Challenge teams to avoid superficial or convenience‑based conclusions Ensure microbial deviations receive appropriate SME engagement (QC Micro, aseptic SMEs) Verify investigations reflect true contamination risks and classifications reflect risk Facilitate alignment between FAO, QA and Deviation Owner; ensure decisions are clearly documented Ensure CAPAs are assigned, owned, and completed effectively; confirm clear linkage between root cause and actions Lead daily deviation triage for environmental and contamination control‑related events; prioritize high‑risk events; ensure effective tools and processes for tracking and reporting record progress; allocate resources appropriately Prepare team to speak to deviations directly and defend scientific rationale; keep records inspection‑ready Create a culture of continuous improvement and implement tools and processes that streamline the investigation process, using AI and digital tools Key performance metrics: on‑time closure, aging backlog, investigation effectiveness, CAPA cycle time, audit/inspection observations Basic Qualifications High school diploma/GED and 12 years of manufacturing or operations experience Associates degree and 10 years of manufacturing or operations experience Bachelor’s degree and 5 years of manufacturing or operations experience Master’s degree and 3 years of manufacturing or operations experience Doctorate degree Experience directly managing people and/or leading teams, projects, programs, or directing allocation of resources, concurrent with required technical experience Preferred Qualifications BS/BA or equivalent (science/engineering/psychology preferred) 8+ years in the pharmaceutical industry Experience applying AI or other digital tools to generate insights and streamline workflows Strong understanding of deviation management process, root cause analysis and GMP compliance Ability to drive execution through others, manage multiple priorities, influence cross‑functional teams, and provide performance management and coaching for a team of professionals Benefits From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. A 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 Flexible work models where possible Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. #J-18808-Ljbffr Amgen