Process Development Associate at Amgen in Thousand Oaks, CA

Job description

Career Category Operations 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. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. 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. Process Development Associate What you will do Let’s do this. Let’s change the world. In this vital role you will independently execute established analytical methods, accurately document laboratory activities, evaluate and interpret analytical data, and ensure testing is performed in accordance with approved procedures, specifications, and applicable GMP requirements. Perform routine and non-routine GMP analytical testing of synthetic drug substance, drug product, raw materials, stability samples, and other materials as required. Execute testing according to approved analytical methods, specifications, SOPs, protocols, and applicable GMP requirements. Plan and organize laboratory activities to meet testing timelines and business priorities with minimal supervision. Accurately document sample preparation, reagent and standard preparation, instrument conditions, calculations, observations, and results in accordance with GMP and data integrity requirements. Review, analyze, and interpret analytical data to ensure results are scientifically sound, complete, traceable, and reliable. Operate and maintain standard laboratory equipment and analytical instrumentation. Experience with one or more analytical techniques such as HPLC/UPLC, GC, dissolution, UV-Vis, FTIR, Karl Fischer, ion chromatography, wet chemistry, and/or LC-MS is preferred. Troubleshoot analytical methods, instrumentation, sample preparation, and laboratory execution issues and escalate when appropriate. Recognize atypical results, laboratory events, deviations, and potential data-quality issues and promptly communicate them through appropriate GMP processes. Support laboratory investigations, deviations, CAPAs, change controls, method-related assessments, and other quality-system activities as required. Support analytical method transfer, qualification, verification, and validation activities. Effectively transfer analytical procedures into the GMP laboratory and identify scientifically justified modifications or improvements when appropriate. Prepare and review technical documentation, including laboratory notebooks, worksheets, protocols, reports, summaries, and other GMP documentation. Maintain appropriate control and traceability of standards, reagents, solutions, samples, and laboratory materials. Ensure laboratory activities comply with applicable safety requirements, procedures, and regulatory expectations. Communicate testing status, analytical results, technical issues, and potential risks clearly to laboratory management and cross-functional stakeholders. Participate in scientific and technical discussions and provide interpretation of analytical data to the broader project team. Coordinate laboratory resources, instrumentation, materials, and testing activities necessary to complete assigned work. Contribute to continuous improvement efforts focused on laboratory efficiency, compliance, data quality, and operational excellence. Support regulatory inspe