Senior Associate Manufacturing
Amgen
8 hours ago
On-site
Thousand Oaks, CA
Operations
Senior Associate Manufacturing
Responsibilities:
- Support manufacturing as Single-use SME for drug substance downstream processes.
- Resolve quick issues; implement function tests to troubleshoot and optimize process.
- Write protocols/reports for validation, function testing, equipment commissioning/qualification, and change management.
- Own quality records (CCMS, CAPA, CAPA-EV).
- Work various shifts as scheduled; execute function-testing and project tasks with minimal disruption.
- Perform work in clean rooms (GMP/SOP compliance; steel toe shoes, full gowning, hairnet, gloves).
- Use technical/process/compliance knowledge for analytical troubleshooting and implementation of new technologies.
- Champion continual improvement and strategic problem-solving.
- Develop/own drug substance manufacturing processes and GMP documents (SOPs, forms); draft user requirements for new technologies.
- As Single-use SME: support SUS mapping for new product introduction; SUS defect/leak triage (troubleshoot, investigate, triage); initiate EN/SICAR through conclusion (including vendor work); maintain EN/SICAR/EE trackers and manage/lead small–medium projects.
Basic Qualifications:
- High school/GED + 4 years manufacturing/operations OR Associate’s + 2 years OR Bachelor’s + 6 months; Master’s.
Preferred Qualifications:
- Degree in Engineering or Life Sciences; 3+ years in drug substance GMP technical support or equivalent.
- Technical knowledge of drug substance processing; strong technical writing/presentation; coach/mentor; cross-functional leadership; project leadership.
- Single-use technology understanding; data analysis/visualization; Smartsheet/Excel, Trackwise, Visio, PI, SAP, Spotfire.
Benefits (if eligible): employee benefits incl. retirement/savings with company contributions, medical/dental/vision, life/disability, flexible spending; annual bonus/incentive; stock-based long-term incentives; time off; flexible work models where possible.
Application Instructions:
- Apply now at careers.amgen.com (no application deadline; continue until sufficient candidates or selection).
Responsibilities:
- Support manufacturing as Single-use SME for drug substance downstream processes.
- Resolve quick issues; implement function tests to troubleshoot and optimize process.
- Write protocols/reports for validation, function testing, equipment commissioning/qualification, and change management.
- Own quality records (CCMS, CAPA, CAPA-EV).
- Work various shifts as scheduled; execute function-testing and project tasks with minimal disruption.
- Perform work in clean rooms (GMP/SOP compliance; steel toe shoes, full gowning, hairnet, gloves).
- Use technical/process/compliance knowledge for analytical troubleshooting and implementation of new technologies.
- Champion continual improvement and strategic problem-solving.
- Develop/own drug substance manufacturing processes and GMP documents (SOPs, forms); draft user requirements for new technologies.
- As Single-use SME: support SUS mapping for new product introduction; SUS defect/leak triage (troubleshoot, investigate, triage); initiate EN/SICAR through conclusion (including vendor work); maintain EN/SICAR/EE trackers and manage/lead small–medium projects.
Basic Qualifications:
- High school/GED + 4 years manufacturing/operations OR Associate’s + 2 years OR Bachelor’s + 6 months; Master’s.
Preferred Qualifications:
- Degree in Engineering or Life Sciences; 3+ years in drug substance GMP technical support or equivalent.
- Technical knowledge of drug substance processing; strong technical writing/presentation; coach/mentor; cross-functional leadership; project leadership.
- Single-use technology understanding; data analysis/visualization; Smartsheet/Excel, Trackwise, Visio, PI, SAP, Spotfire.
Benefits (if eligible): employee benefits incl. retirement/savings with company contributions, medical/dental/vision, life/disability, flexible spending; annual bonus/incentive; stock-based long-term incentives; time off; flexible work models where possible.
Application Instructions:
- Apply now at careers.amgen.com (no application deadline; continue until sufficient candidates or selection).