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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.
Additional Qualifications/Responsibilities
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 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.
Salary Range
86,048.05USD -116,417.95 USD
