Pilot Plant Manufacturing Expert
Pilot Plant Manufacturing Expert
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Job Description
Job Description Summary
Responsible 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.Job Description
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.
Design 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. Manage 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.
Why Novartis Our purpose is to reimagine medicine to improve and extend peoples lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: will receive: You can find everything you need to know about our benefits and rewards in the Novartis Life
:// 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.
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Environment Experiments Design Health And Safety (Ehs) Laboratory Equipment Manufacturing Process Materials Science Process Simulation Sop (Standard Operating Procedure) Technical Writing Waterfall ModelEmployment Type
Full-Time
