Senior Manufacturing Associate Single Use Systems; SUS

Senior Manufacturing Associate – Single Use Systems (SUS)

Join us to apply for the Senior Manufacturing Associate – Single Use Systems (SUS) role at Amgen.

At Amgen, our mission is to serve patients living with serious illnesses. Since 1980, we have pioneered biotech innovations across oncology, inflammation, general medicine, and rare disease. Our culture is collaborative, innovative, and science‑based. As part of the Amgen team, you will help manufacture and deliver innovative medicines that improve patient lives.

• Support New Product introduction and projects through SUS mapping/drawing.
• Maintain and edit SUS Standard Operating Procedures (SOP).
• Support manufacturing and quality through the SUS defect/leak triage process; perform troubleshooting on the floor, initiate investigations and bring leaks and defects to triage meetings.
• Initiate Event Notification (EN)/Supplier Investigation/Corrective Action (SICAR) records and follow process to conclusion, including collaborating with vendors on investigation.
• Maintain up-to-date EN/SICAR/Early Engagement (EE=new item) trackers and manage or lead small to medium projects.
• Provide input for ANC representative to SUS network for improvements and troubleshooting.
• Support Vendor Change Notification assessments.
• Understand single‑use material capabilities and user requirements for new technologies through interaction with end users.
• Collaborate with Continuous Improvement leads to help SUS improvement projects and provide/lead use cases for continuous improvement projects, such as improvements around tubing management, material kitting and flow.

• High School/GED and 4 years of manufacturing or operations work experience.
• Associate’s Degree and 2 years of manufacturing or operations work experience.
• Bachelor’s Degree and 6 months of manufacturing or operations work experience.
• Master’s Degree.

• Experience with and understanding of Single-Use Systems.
• Experience in Drug substance GMP technical support roles, GMP manufacturing, Engineering, Process Development, or equivalent.
• Technical knowledge of drug substance processing and broad understanding of related disciplinary areas.
• Ability to successfully communicate complex technical information with internal and external colleagues of varying organizational levels in both presentation and technical writing forms.
• Ability to coach, mentor and/or cross‑train colleagues within core technical area.
• Team player – Ability to support process owner team by reprioritizing or readjusting projects, tasks, or responsibilities.
• Ability to drive results through leadership of cross‑functional teams.
• Data analysis and/or data visualization skills.
• Excellent writing skills; presentation experience to leadership.
• Determines work tasks and timelines self‑sufficiently; ability to navigate through ambiguity and prioritize effectively.
• Proficiency in computerized systems for example, Smartsheet, Excel, Trackwise, Veeva, Visio.
• Expertise with translating business/user needs to user requirements and recommend solutions.
• Experience in individually supporting key manufacturing systems with 24x7 operations.
• Ability to work in fast‑paced manufacturing environment where issues must be assessed, understood, and resolved immediately.
• Collaborate with staff at all levels in the organization, including technical and management staff within manufacturing, process development, and quality.
• Pro‑active, result oriented, and ability to prioritize work to meet timelines.

In addition to a competitive base salary, Amgen offers comprehensive Total Rewards Plans aligned with local industry standards and supports your professional and personal growth.

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.

Apply now and make a lasting impact with the Amgen team.