Senior Associate Manufacturing, Drug Product

** 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-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.

** Senior Associate Manufacturing*
* ** 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  
** Sr Associate Manufacturing I 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. 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*
* ** 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 dynamic professional we seek is an employee with these qualifications.

** Basic Qualifications*
* + Master's degree OR

+ Bachelor's degree and 6 months of Manufacturing support experience OR

+ Associate's degree and 2 years of Manufacturing support experience OR

+ High school diploma / GED and 4 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

+ 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…