Sr. Associate Manufacturing Production Process Owner

Career Category

Manufacturing

Job Description

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Sr. Associate Manufacturing Production Process Owner

What you will do

Let’s do this. Let’s change the world. In this vital role 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:

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.

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.

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.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a go getter with these qualifications.

Basic Qualifications:

• High school/GED + 4 years Manufacturing support experience OR
• Associate’s + 2 years Manufacturing support experience OR
• Bachelor’s + 6 months Manufacturing support experience OR
• Master's

Preferred Qualifications:

• Advanced degree (Master’s or Ph.D.) in Engineering, Biotechnology, or related field
• Experience in aseptic Drug Product or biologics manufacturing
• Knowledge of process validation, deviation management, and change control
• Strong analytical and problem-solving skills with experience using data visualization tools (Spotfire, JMP, Excel)