Specialist Manufacturing - Downstream DS

Responsibilities Provide subject‑matter expertise for drug substance downstream as process owner (PPO). Lead cross‑function and complex projects using project‑management skills. Resolve quick issues and lead troubleshooting, including execution of function tests to troubleshoot and optimize processes. Write protocols and reports in support of validation, function testing, equipment commissioning, qualification, and change management. Own quality records such as CCMS, CAPA, and CAPA‑EV. Apply technical, scientific, operational, and compliance knowledge with analytical troubleshooting skills to support the implementation of new technologies into the plant. Demonstrate strategic problem‑solving skills and champion continual improvement. Present to inspectors on areas of expertise. Mentor and train junior staff. Be on‑site (flexible worker), work various shifts (day, swing, grave, weekends, holidays, 5x8 hrs, 4x10 hrs) as instructed by the production schedule to execute function‑testing and project tasks with minimal disruption to operations. Work in a clean room environment wearing steel‑toe shoes, full clean‑room gowning, hairnet and gloves, following GMP documents (SOPs) with strict adherence to safety and compliance. Lead operational readiness of new technologies, equipment, or processes, providing assessment and advice on process impact for changes. Develop/own drug substance manufacturing processes and procedures. Draft and revise GMP manufacturing documents (SOPs, forms). Draft and develop user requirements for new technologies. Qualifications Basic Qualifications: Doctorate degree or Master’s degree and 2 years of manufacturing and/or operations experience. Bachelor’s degree and 4 years of manufacturing and/or operations experience. Associate’s degree and 8 years of manufacturing and/or operations experience. High school diploma / GED and 10 years of manufacturing and/or operations experience. Preferred Qualifications: Degree in Engineering or Life Sciences. 3+ years of experience in drug substance GMP technical support roles, GMP manufacturing, engineering, process development or equivalent. Technical knowledge of drug substance processing and broad understanding of related disciplinary areas. Ability to navigate ambiguity, identify and deliver on key milestones, and advise and influence using data. Excellent communication and mentoring skills; ability to coach and cross‑train colleagues. Experience leading and managing projects and cross‑functional teams. Understanding of single‑use technologies and data analysis/visualization skills. Excellent writing and presentation skills. Proficiency in Smartsheet, Excel, Trackwise, Visio, PI, SAP, Spotfire. Benefits Competitive salary based on experience and qualifications. Health, dental, vision, life and disability insurance; flexible spending accounts. Retirement and savings plan with company contribution. Discretionary annual bonus program. Stock‑based long‑term incentives. Generous paid time‑off plans. Flexible work models where possible. EEO Statement Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. #J-18808-Ljbffr Amgen Inc. (IR)