Specialist Manufacturing - Production Process Owner

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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. 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.

Specialist Manufacturing - DP Production Process Owner

What you will do

Let’s do this. Let’s change the world. At Amgen, our mission—to serve patients—drives everything we do. As a Specialist Manufacturing in Drug Product (DP)/Visual Inspection (VI) Operations as a Production Process Owner 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. 

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. 

Key Responsibilities 

Change Control and Continuous Improvement 

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. 

Basic Qualifications 

• Doctorate degree OR 

• Master’s degree and 2 years of Manufacturing support experience OR 

• Bachelor’s degree and 4 years of Manufacturing support experience OR 

• Associate’s degree and 8 years of Manufacturing support experience OR

• High school diploma / GED and 10 years of Manufacturing support experience 

Preferred Qualifications 

• Advanced degree (Master’s or Ph.D.) in Engineering, Biotechnology, or related field 

• Experience in aseptic Drug Product or biologics manufacturing 

• Experience in Automated/Manual Visual Inspection (AVI/MVI) Operations

• 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 

Competencies for Success 

• 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.