Specialist, Manufacturing Production Process Owner

About the role

At Amgen, our mission to serve patients drives everything we do. As a Specialist Manufacturing in Drug Product (DP) Operations at our Thousand Oaks (ATO) manufacturing site, you will play a key role in ensuring our commercial and clinical manufacturing processes are compliant, efficient, and continuously improving. This role will support Major Deviations from a DP Process standpoint. You will partner with cross-functional teams—including Engineering, Quality, Process Development, and Operations—to implement process improvements, support new technology introductions, and maintain robust GMP manufacturing performance. Your work will directly contribute to Amgen’s ability to deliver life-changing therapies to patients worldwide.

Responsibilities

• Deviation and CAPA Management
  • Support timely investigation and resolution of manufacturing deviations.
  • Participate in root cause analyses (RCA) and human performance evaluations.
  • Contribute to the development and implementation of effective corrective and preventive actions (CAPAs) and monitor CAPA effectiveness.
• Documentation and Process Management
  • Initiate, revise, and approve controlled manufacturing documents within Amgen’s electronic document management system (CDOCs).
  • Serve as document author, owner, reviewer, or data verifier, ensuring accuracy and compliance with current GMP and Amgen standards.
  • Maintain documentation to accurately reflect operational practices and regulatory requirements.
• Process Implementation and Project Execution
  • Support implementation of new processes, equipment, and major initiatives within Drug Product operations.
  • Collaborate with Capital, Engineering, Process Development, Quality, and other functions to define requirements and achieve operational readiness.
  • Assist in developing and implementing SOPs, batch records, training, validation, and automation configurations.
• Operational Performance and Data Analytics
  • Analyze manufacturing data and performance metrics to identify trends, deviations, and opportunities for improvement.
  • Develop and implement data-driven solutions to improve yield, reliability, and compliance.
  • Support data monitoring using analytical tools such as Enterprise Data Lake and Spotfire, ensuring configuration alignment with process design and GMP requirements.
• Validation and Process Control
  • Assist in developing and executing process validation protocols and reports.
  • Collect, analyze, and interpret validation and process monitoring data to ensure process robustness and compliance.
  • Support establishment of process parameters, control limits, and performance reporting.
• Change Control and Continuous Improvement
  • Support change control activities to ensure GMP, regulatory, and operational compliance.
  • Evaluate and justify process or equipment changes and assist with project execution.
  • Participate in continuous improvement and operational excellence initiatives to enhance safety, quality, and efficiency within DP operations.

Requirements

• Doctorate degree
• OR Master’s degree and 2 years of manufacturing experience
• OR Bachelor’s degree and 4 years of manufacturing experience
• OR Associate’s degree and 8 years of manufacturing experience
• OR High school diploma / GED and 10 years of manufacturing experience

Preferred Qualifications

• Advanced degree (Master’s or Ph.D.) in Engineering, Biotechnology, or related field
• Experience in aseptic Drug Product or biologics manufacturing
• Previous experience in Root Cause Analysis and Major Deviations
• Knowledge of process validation, deviation management, and change control
• Strong analytical and problem-solving skills with experience using data visualization tools (Spotfire, JMP, Excel)
• Excellent written and verbal communication skills and ability to collaborate across functions

Skills

• Operational Excellence: Demonstrates attention to detail, prioritizes quality and compliance, and drives process improvements.
• Technical Expertise: Applies technical knowledge to evaluate, troubleshoot, and optimize manufacturing processes.
• Collaboration: Builds strong cross-functional relationships and fosters teamwork across disciplines.
• Accountability: Takes ownership of deliverables and ensures timely completion of commitments.
• Continuous Improvement: Identifies and implements opportunities to enhance manufacturing performance and reliability.

Benefits

• A comprehensive employee benefits package, including:
  • A Retirement and Savings Plan with generous company contributions
  • Group medical, dental, and vision coverage
  • Life and disability insurance
  • Flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible

Pay

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.