DP Manufacturing Specialist: Process Excellence & Compliance

Amgen SA; Thousand Oaks (CA); On-site; USD 120,000 - 170,000; Full time

Benefits offered by this job

Competitive benefits

Stock-based incentives

Job summary

Amgen’s Thousand Oaks site seeks a Specialist Manufacturing - Production Process Owner to ensure compliant, efficient DP operations and lead deviations and CAPA initiatives.

You will collaborate across Engineering, Quality, Process Development, and Operations to implement process improvements, support new technology, and maintain robust GMP performance while advancing life‑changing therapies.

Qualifications

• Doctorate or Master’s with manufacturing experience as listed in the ad.
• Relevant experience in drug product operations or biologics preferred.
• Strong analytical and problem-solving skills; cross-functional collaboration.

Responsibilities

• Manage deviations and CAPA; participate in root cause analyses.
• Develop, revise, and control manufacturing documents per GMP.
• Support SAP/automation changes and SOPs; ensure regulatory alignment.
• Analyze data to improve yield, reliability, and compliance.
• Assist in validation protocols, parameters, and reporting.
• Contribute to continuous improvement and operational excellence.

Skills

Project coordination

Communication

Problem-solving

Collaboration

Data analytics

Attention to detail

Process improvement

Education

Doctorate degree

Master's degree + 2 years manufacturing experience

Bachelor's degree + 4 years manufacturing experience

Associate's degree + 8 years manufacturing experience

High school diploma / GED + 10 years manufacturing experience

Tools

Spotfire

JMP

Excel

Job description

Amgen’s Thousand Oaks site seeks a Specialist Manufacturing - Production Process Owner to ensure compliant, efficient DP operations and lead deviations and CAPA initiatives.

You will collaborate across Engineering, Quality, Process Development, and Operations to implement process improvements, support new technology, and maintain robust GMP performance while advancing life‑changing therapies.