Ph3Summary /h3 pResponsible for technology transfer activities and frontline technical and scientific expert support for all process-specific issues to ensure execution of processes on‑time (business continuity) in compliance with cGMPs, SOPs and applicable guidelines and functional standards, and to allow continuous improvement in quality, productivity and efficiency. /p h3About The Role /h3 pKey responsibilities: /p 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 liDesigns 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. Manages 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 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 h3Benefits /h3 pYou will receive: /p pFull benefits and rewards information in the Novartis Life Handbook. /p /p #J-18808-Ljbffr