Specialist Manufacturing New Product Introduction (NPI):Downstream Readiness

Role: Specialist Manufacturing NPI - Downstream Readiness at Amgen's biologics manufacturing plant, focusing on integrating new drug products and technologies into GMP production. Responsibilities: lead cross-functional teams to ensure successful tech transfer, manage change controls, support troubleshooting, and drive continuous improvement initiatives. Acts as technical expert for drug substance processing, including cell culture and purification, and champions lean manufacturing and operational excellence. Qualifications: high school diploma with 10+ years or advanced degrees with 2-4 years biotech operations experience; strong project management, technical writing, and GMP manufacturing knowledge. High-value specifics: biologics drug substance production, cell culture, chromatography, filtration, process validation, regulatory compliance, and industry 4.0 technologies. Stakeholder interaction includes manufacturing, process development, supply chain, quality, and engineering teams. Work setup offers flexible models, with significant cross-functional collaboration within a large-scale, innovative biopharma environment.