Pilot Plant Manufacturing

2 giorni fa

Montà, Italia Novartis Italia A tempo pieno

Summary Responsible 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. About The Role Key responsibilities: Provides 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. Designs 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. Leads 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). Partners with QA, QC and Regulatory for RLT dossiers and audits; maintains GMP documentation and master records for radionuclide precursors, conjugates, and final drug product. Drives 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. Manages 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. Promotes 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. Aligns 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. Essential Requirements Language: English fluent; Italian proficient. Experience: 2 years in GMP manufacturing support/technical roles; or 8 years in field for lower education levels. Strong scientific and technical understanding with rapid grasp of pharmaceutical production processes. Radio-pharma knowledge/experience would be a plus. Quality, compliance, and pharma regulatory awareness. Team player with strong collaboration, negotiation, influencing, and persuasion skills. Change management, adaptability, and resilience under pressure. Knowledge of MES and ERP systems (e.g., MES, SAP) and related manufacturing IT. Solid command of office productivity software. Commitment to Diversity and Inclusion Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. Benefits You will receive: Full benefits and rewards information in the Novartis Life Handbook. J-*****-Ljbffr

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