Senior Associate Manufacturing
$86,048–$116,417 year
On-site · Thousand Oaks, California, United States
Job Summary
Senior Associate Manufacturing at Amgen provides SME-level support for drug-substance downstream processes within the Manufacturing Systems team. Responsibilities include troubleshooting and optimizing processes, writing validation-related protocols and reports, owning Quality Records (CCMS, CAPA, CAPA-EV), supporting new product introductions and single-use technologies, SUS mapping, defect/leak triage with vendors, and maintaining GMP-compliant documentation. The role requires ability to work various shifts in a clean-room environment, apply analytical and regulatory knowledge to implement new technologies, lead small-to-medium projects, and collaborate across cross-functional teams to drive continual improvement. The position emphasizes on-site work at the Thousand Oaks facility with flexibility to support on-site readiness of new technologies and processes, while leveraging tools like Smartsheet, Trackwise, SAP, Visio, and Excel for data analysis and project management.
Required Qualifications
- High school/GED + 4 years manufacturing and operations experience
- Associate’s + 2 years manufacturing and operations experience
- Bachelor’s + 6 months manufacturing and operations experience
- Master’s Degree in Engineering or Life Sciences (preferred)
- 3+ years in Drug substance GMP technical support roles or GMP manufacturing (preferred)
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