Location: Ivrea, ItalyRole Purpose:Leads the site's Manufacturing Functions organization (RLT Pilot Plant) which ensures that equipment, infrastructure and manufacturing area are fully operational, meet regulatory, GMP and HSE compliance and are further developed to meet future requirements and business needs.Lead TRD RLT Pilot Plant to manufacture and supply high quality and value radiopharmaceutical products on time, every time, safely, environmental sustainably and efficiently. The Pilot Plant Director will provide servant leadership, strategies, and guidance to the RLT Pilot Plant in NCE comprising of multiple projects, operations, and initiatives by optimally setting up processes, assets to best serve the Development team as well as the Clinical Supplies worldwide.
About the RoleMajor accountabilities: Define and plan all requirements of GMP production with project execution plans and approve and ensure the proper implementation of production requirementsEnsure Pilot Plant RLT objectives are in compliance with Quality, Customer Service, Health and Safety and regulatory requirementsDrive lean production and continuous improvement to enable Pilot Plant performance to remain competitive and compliantDevelop and leverage communities of practice in operational excellence for embedding IQPDevelop, monitor and report on KPI's and performance measures to enable strategic objectives to be met or remedial actions to be taken. Permanent measurement, benchmarking und continuous improvement of KPI'sSupport preparation of financial OPEX & CAPEX budget and ensure that the approved budget is metEconomic management of costs, working capital and investments, e.g. by efficient planning and utilization of technical and human resourcesCoaching, leadership, development and motivation of associates. Support of team-building, empowerment and conduct the team to a process oriented organizationEnsure Compliance with Quality Manual / Quality Modules / STDs and host health authority auditsAdvanced degree in chemistry, pharmaceutics or related science. (Ph.D. in scientific or relevant discipline or equivalent preferred). IQP/Lean education & certificationFluent in English and proficient in local language10+ years' experience in the Pharmaceutical industryDetailed knowledge of GMPTrained to have knowledge of industry HSE processes and proceduresExtended HSE and GxP/QA knowledgeWhy Advanced Accelerator Applications?
Thousands of people die of cancer around the world every day. At Advanced Accelerator Applications, a Novartis company, our mission is to transform lives through radioligand therapy in nuclear medicine to fight several leading types of cancer. How will we continue to be on the cutting edge of medicine? We believe new groundbreaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world's toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
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Division International
Business Unit Pharmaceuticals
Location Italy
Site Ivrea
Company / Legal Entity IT58 (FCRS = IT058) AAA Italy Srl.
Functional Area Research & Development
Job Type Full time
Employment Type Regular
Shift Work No
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