Senior Associate Manufacturing

Career CategoryManufacturingJob DescriptionJoin Amgen’s Mission of Serving PatientsAt 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 ManufacturingWhat you will doLet’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 ResponsibilitiesDocumentation and Process ManagementInitiate, 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 ExecutionSupport 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 AnalyticsAnalyze 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 ManagementSupport 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 ControlAssist 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 ImprovementSupport 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 youWe 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 QualificationsMaster’s degree ORBachelor’s degree and 6 months of Manufacturing support experience ORAssociate’s degree and 2 years of Manufacturing support experience ORHigh school diploma / GED and 4 years of Manufacturing support experiencePreferred QualificationsAdvanced degree (Master’s or Ph.D.) in Engineering, Biotechnology, or related fieldExperience in aseptic Drug Product or biologics manufacturingKnowledge of process validation, deviation management, and change controlStrong 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 functionsCompetencies for SuccessOperational 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.What you can expect of usAs we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.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, e