Senior Associate Manufacturing
Amgen
June 29, 2026
On-site
Thousand Oaks, CA
Operations
Senior Associate Manufacturing I – Drug Product (DP) Operations (Thousand Oaks / ATO)
Responsibilities
- Initiate, revise, and approve controlled manufacturing documents in CDOCs; serve as author/owner/reviewer/data verifier to ensure GMP/Amgen compliance.
- Maintain documentation reflecting operational practices and regulatory requirements.
- Support implementation of new processes/equipment/initiatives in DP operations; collaborate cross-functionally for operational readiness.
- Develop and implement SOPs, batch records, training, validation, and automation configurations.
- Analyze manufacturing data/performance metrics to identify trends, deviations, and improvement opportunities.
- Develop data-driven solutions to improve yield, reliability, and compliance; support monitoring using Enterprise Data Lake and Spotfire.
- Support investigation/resolution of manufacturing deviations; participate in RCA and human performance evaluations.
- Contribute to CAPA development/implementation and monitor CAPA effectiveness.
- Assist with process validation protocols/reports; interpret validation/monitoring data to ensure robustness and compliance.
- Support change control and continuous improvement to enhance safety, quality, and efficiency.
Basic Qualifications
- Master’s degree OR
- Bachelor’s degree + 6 months manufacturing support experience OR
- Associate’s degree + 2 years manufacturing support experience OR
- High school diploma/GED + 4 years manufacturing support experience
Preferred Qualifications
- Advanced degree (Master’s or Ph.D.) in Engineering/Biotech/related field
- Aseptic Drug Product or biologics manufacturing experience
- Process validation, deviation management, and change control knowledge
- Data visualization tools experience (Spotfire/JMP/Excel)
- Strong written/verbal communication and cross-functional collaboration
Application Instructions
- Apply via careers.amgen.com; no application deadline (applications accepted until sufficient candidates or selection).
Responsibilities
- Initiate, revise, and approve controlled manufacturing documents in CDOCs; serve as author/owner/reviewer/data verifier to ensure GMP/Amgen compliance.
- Maintain documentation reflecting operational practices and regulatory requirements.
- Support implementation of new processes/equipment/initiatives in DP operations; collaborate cross-functionally for operational readiness.
- Develop and implement SOPs, batch records, training, validation, and automation configurations.
- Analyze manufacturing data/performance metrics to identify trends, deviations, and improvement opportunities.
- Develop data-driven solutions to improve yield, reliability, and compliance; support monitoring using Enterprise Data Lake and Spotfire.
- Support investigation/resolution of manufacturing deviations; participate in RCA and human performance evaluations.
- Contribute to CAPA development/implementation and monitor CAPA effectiveness.
- Assist with process validation protocols/reports; interpret validation/monitoring data to ensure robustness and compliance.
- Support change control and continuous improvement to enhance safety, quality, and efficiency.
Basic Qualifications
- Master’s degree OR
- Bachelor’s degree + 6 months manufacturing support experience OR
- Associate’s degree + 2 years manufacturing support experience OR
- High school diploma/GED + 4 years manufacturing support experience
Preferred Qualifications
- Advanced degree (Master’s or Ph.D.) in Engineering/Biotech/related field
- Aseptic Drug Product or biologics manufacturing experience
- Process validation, deviation management, and change control knowledge
- Data visualization tools experience (Spotfire/JMP/Excel)
- Strong written/verbal communication and cross-functional collaboration
Application Instructions
- Apply via careers.amgen.com; no application deadline (applications accepted until sufficient candidates or selection).