RLT Formulation Project Leader
3 settimane fa
Summary Create and drive with scientific & technological excellence the formulation development in close collaboration with operations, analytics, engineering and relevant SMEs, QA and the project DPPL. Development activities includes among others: formulation and process-design, control strategy, quality risk management, authoring of development documents and manufacturing instructions for technical and GMP manufacture incl. handling of deviation. Role Responsibilities Lead the development of formulations and manufacturing processes of Drug Products Support the development and the qualification of analytical methods together with the AS&T team leader in accordance with ICHs guidelines and internal SOPs. Participate as formulation expert to cross-functional project teams. Be accountable for all formulation and manufacturing process deliverables incl. scientific documentation for all assigned projects (Manufacturing instructions, GMP documents, deviation..) Guarantee technical support answering DP related questions in inspections and Health Authority requests throughout all phases of the project life cycle. Participate to the transfer manufacturing procedures to the relevant department (e.g. Technical Operations, CDMO, etc.). Ensure authoring of accurate, comprehensible, structured, complete and legible documents to allow timely start of development trials, process transfers and supply activities. Draft the CMC documents required to enable regulatory submissions (IND/IMPD, Module3/NDA). Provide technical guidance to team members and work according to appropriate SOPs, GLP, GMP, HSE and AdAcAp / Novartis guidelines. Proactively communicate key issues and any other critical topic in a timely manner to the appropriate management level, to the TRD DPPL and/or to any other relevant project team member. Essential Requirements Minimum: PhD in Pharmaceutics or related sciences with a minimum of 3 years of proven experience within the pharmaceutical/biotech industry or a Master’s degree with a minimum of 5 years experience. Fluent knowledge of English (oral and written). Desirable knowledge of site language. Demonstrated success in developing formulations with an emphasis in liquid sterile dosage forms. Technical expertise and detailed understanding of drug product production and control technologies. Experience with outsourcing and supervising work done by CRO/CMOs including technical overview of agreement set up. Experience in writing CMC documents for regulatory submissions and responding to health authority questions. Good basis of Quality Assurance (overall knowledge of GxPs). Work Experience Functional Breadth. Operations Management and Execution. Collaborating across boundaries. Skills Environment. Experiments Design. Health And Safety (EHS). Laboratory Equipment. Manufacturing Process. Materials Science. Process Simulation. Project Management. SOP (Standard Operating Procedure). Technical Writing. Languages English. Why Novartis Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? Benefits and Rewards Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: Seniority Level Mid-Senior level Employment Type Full-time Job Function Project Management and Information Technology Industry Pharmaceutical Manufacturing #J-18808-Ljbffr
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RLT Formulation Project Leader
2 settimane fa
Ivrea, Italia Novartis Italia A tempo pienoSummary Create and drive with scientific & technological excellence the formulation development in close collaboration with operations, analytics, engineering and relevant SMEs, QA and the project DPPL. Development activities includes among others: formulation and process-design, control strategy, quality risk management, authoring of development documents...
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Rlt Formulation Project Leader
2 settimane fa
Ivrea, Italia Novartis A tempo pieno**Summary**: Create and drive with scientific & technological excellence the formulation development in close collaboration with operations, analytics, engineering and relevant SMEs, QA and the project DPPL. Development activities includes among others: formulation and process-design, control strategy, quality risk management, authoring of development...
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RLT Formulation Project Leader
3 settimane fa
ivrea, Italia Novartis Italia A tempo pienoSummaryCreate and drive with scientific & technological excellence the formulation development in close collaboration with operations, analytics, engineering and relevant SMEs, QA and the project DPPL. Development activities includes among others: formulation and process-design, control strategy, quality risk management, authoring of development documents...
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RLT Formulation Project Leader
4 settimane fa
ivrea, Italia Novartis Farmacéutica A tempo pienoCreate and drive with scientific & technological excellence the formulation development in close collaboration with operations, analytics, engineering and relevant SMEs, QA and the project DPPL. Development activities includes among others: formulation and process-design, control strategy, quality risk management, authoring of development documents and...
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RLT Formulation Project Leader
2 settimane fa
ivrea, Italia Attività alberghiera A tempo pienoCreate and drive with scientific & technological excellence the formulation development in close collaboration with operations, analytics, engineering and relevant SMEs, QA and the project DPPL. Development activities includes among others: formulation and process-design, control strategy, quality risk management, authoring of development documents and...
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Data Governance
2 settimane fa
Ivrea, Italia Novartis Pharma Schweiz A tempo pienoA global healthcare leader is seeking an RLT Systems Integration Governance Manager in Ivrea, Italy. This full-time role involves architecting the governance of data across key domains to enable operational readiness and continuous improvement. Ideal candidates should have a degree in a related field and solid experience in data governance. Responsibilities...
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Data Governance
2 settimane fa
Ivrea, Italia Altro A tempo pienoA global healthcare leader is seeking an RLT Systems Integration Governance Manager in Ivrea, Italy. This full-time role involves architecting the governance of data across key domains to enable operational readiness and continuous improvement. Ideal candidates should have a degree in a related field and solid experience in data governance. Responsibilities...
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RLT Systems Integration Governance Manager
2 settimane fa
Ivrea, Italia Novartis Pharma Schweiz A tempo pienoRLT Systems Integration Governance Manager Join to apply for the RLT Systems Integration Governance Manager role at Novartis Pharma Schweiz Overview This role is responsible for architecting the structure and governance of data across key domains of the RLT (Radio Ligand Therapy) Supply Chain, including Integrated Business Planning (IBP), Planning,...
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RLT Systems Integration Governance Manager
2 settimane fa
Ivrea, Italia Novartis Italia A tempo pienoRLT Systems Integration Governance Manager Join to apply for the RLT Systems Integration Governance Manager role at Novartis Italia This role is responsible for architecting the structure and governance of data across key domains of the RLT (Radio Ligand Therapy) Supply Chain, including Integrated Business Planning (IBP), Planning, Logistics, Product...
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RLT Systems Integration Governance Manager
2 settimane fa
Ivrea, Italia Altro A tempo pienoRLT Systems Integration Governance Manager Join to apply for theRLT Systems Integration Governance Managerrole atNovartis ItaliaThis role is responsible for architecting the structure and governance of data across key domains of the RLT (Radio Ligand Therapy) Supply Chain, including Integrated Business Planning (IBP), Planning, Logistics, Product Lifecycle...
