Ph3Job Description Summary /h3 pResponsible for technology transfer activities and front line technical and scientific expert support for all process‑specific issues to ensure execution of processes on‑time (business continuity); in compliance to cGMPs, SOPs and applicable guidelines and functional standards and to allow continuous improvement in quality, productivity efficiency. /p h3Job Description /h3 h3Key responsibilities: /h3 ul liProvides frontline SME support on manufacturing on TRD RLT Pilot Plant, including hot‑cell operations, radiolabeling, aseptic handling, and time‑critical troubleshooting on the shop floor. /li liDesign processes for RLT production campaigns to meet short half‑life constraints and just‑in‑time release, ensuring adherence to GMP, HSE/SSE, radiation protection rules, and 5S; performs real‑time batch follow‑up and technical record review. /li liLeads investigations for RLT‑specific deviations and complaints, drives RCA and CAPAs; manages change control and inspection readiness, aligns with site and corporate QMs/GOPs, and monitors RLT portfolio KPIs and trends (APQR, CPV/OPV). /li liPartners with QA, QC and Regulatory for RLT dossiers and audits; maintains GMP documentation and master records for radionuclide precursors, conjugates, and final drug product. /li liDrives Operational Excellence for RLT: cycle‑time and yield improvements under decay constraints, 5S in controlled areas, data analytics and control charts; defines technical needs, URS, and functional specs for manufacturing suites in collaboration with Engineering. /li liManages end‑to‑end Technical Transfers for RLT assets from development laboratory and across sites: recipes/sequences for synthesis and labeling equipment, manufacturing instructions, equipment and process qualifications, technical batches, OPV, change control, and site readiness. /li liPromotes Quality, HSE, and radiation safety culture; enables upskilling of operators and technicians in RLT‑specific procedures; ensures effective communication of technical, quality, HSE, and radiation impacts. Manage manufacturing documentation life‑cycle. /li liAligns all activities with the RLT portfolio strategy and timelines, ensuring manufacturing readiness, inter‑site coordination, and process innovation to support clinical and commercial RLT programs. /li /ul h3Essential requirements: /h3 ul liLanguage: English fluent; Italian proficient. /li liExperience: 2+ years in GMP manufacturing support/technical roles; or 8+ years in field for lower education levels. /li liStrong scientific and technical understanding with rapid grasp of pharmaceutical production processes. Radio‑pharma knowledge/experience would be a plus. /li liQuality, compliance, and pharma regulatory awareness. /li liTeam player with strong collaboration, negotiation, influencing, and persuasion skills. /li liChange management, adaptability, and resilience under pressure. /li liKnowledge of MES and ERP systems (e.g., MES, SAP) and related manufacturing IT. /li liSolid command of office productivity software. /li /ul h3Why Novartis? /h3 pOur purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. With our people, we drive each day to reach our ambitions. /p pBe a part of this mission and join us! Learn more here: /p pYou will receive: /p pYou can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. /p h3Commitment to Diversity and Inclusion /h3 pNovartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. /p h3Join our Novartis Network /h3 pIf this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: /p h3Skills Desired /h3 pEnvironment, Experiments Design, Health And Safety (EHS), Laboratory Equipment, Manufacturing Process, Materials Science, Process Simulation, SOP (Standard Operating Procedure), Technical Writing, Waterfall Model /p /p #J-18808-Ljbffr