Senior Associate Manufacturing - New Product Introduction Systems (Multiple Positions)

Career Category Manufacturing Job Description HOW MIGHT YOU DEFY IMAGINATION? You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role. Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027. Senior Associate Manufacturing - New Product Introduction Systems (Multiple Positions) Live What you will do Let’s do this. Let’s change the world. In this vital role, you will be a key member of the Manufacturing Support team at the Amgen North Carolina (ANC) Biologics Drug Substance Manufacturing plant. This individual contributor will provide focused execution support for New Product Introduction (NPI) programs by coordinating cross-functional activities that enable compliant and timely implementation. The role will primarily work on Quality Risk Assessments, maintain associated Continuous Improvement records, create and maintain process Bills of Materials, and own assigned Change Control records under the guidance of NPI management. The position interacts broadly with Manufacturing, Quality, Process Development, Supply Chain, Manufacturing Execution Systems (MES), and Single-Use Systems (SUS) to align requirements, track execution, and maintain complete and inspection-ready documentation. Responsibilities : Facilitate cross-functional Quality Risk Assessments (QRAs), including planning sessions, coordinating participants and source information, guiding structured risk discussions, documenting decisions, and supporting review and approval. Prepare and maintain QRA reports, Failure Modes and Effects Analyses (FMEAs), risk action logs, and supporting records in accordance with applicable procedures and quality requirements. Create and maintain process Bills of Materials (BOMs) based on approved process and manufacturing requirements. Coordinate BOM inputs, reviews, and reconciliation across Supply Chain, MES, SUS, Manufacturing, and other stakeholders to support accurate material readiness and alignment across systems and documents. Own assigned NPI Change Control records under management guidance; prepare and maintain record content, coordinate required impact assessments and implementation planning, and manage records through applicable lifecycle phases. Track pre-implementation, implementation, and post-implementation tasks, dependencies, due dates, and deliverables; follow up with task owners and escalate risks or delays. Verify that task completion documentation includes the required objective evidence, traceability, and supporting information before routing for approval or closure. Maintain trackers and provide clear, routine status readiness updates to NPI management and cross-functional partners. Build effective relationships across functions, communicate moderately complex issues clearly, navigate ambiguity, and apply structured problem-solving to support timely execution. ​ Win What we expect of you We are all different, yet we all use our unique contributions to serve patients. The detail-oriented manufacturing professional we seek has experience in GMP manufacturing or manufacturing support, with strong cross-functional coordination, meeting facilitation, technical writing, and quality-system skills as well as the below qualifications. Basic Qualifications: Master’s degree OR Bachelor’s degree and 4 years of Manufacturing or Operations experience OR Associate’s degree and 8 years of Manufacturing or Operations experience OR High school diploma / GED and 10 years of Manufacturing or Operations experience ​ Preferred Qualifications: Degree in Science, Engineering, Supply Chain, Operations, or a related field . Experience in GMP biotechnology or pharmaceutical manufacturing, manufacturing support, Process Development, Quality, or Supply Chain. Experience facilitating cross-functional Quality Risk Assessments, FMEAs, or similar structured risk-management activities. Experience using Quality Management Systems such as Veeva QMS or TrackWise for Change Controls, Continuous Improvement records, deviations, CAPAs, or risk-related records. Experience creating or maintaining process or manufacturing Bills of Materials and coordinating material readiness across multiple functions. <span