PCreate 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. /ph3About the Role /h3h3Role Responsibilities: /h3ulliLead the development of formulations and manufacturing processes of Drug Products /liliSupport the development and the qualification of analytical methods together with the AST team leader in accordance with ICHs guidelines and internal SOPs. Participate as formulation expert to cross-functional project teams. /liliBe accountable for all formulation and manufacturing process deliverables incl. scientific documentation for all assigned projects (Manufacturing instructions, GMP documents, deviation..). /liliGuarantee technical support answering DP related questions in inspections and Health Authority requests throughout all phases of the project life cycle. /liliParticipate to the transfer manufacturing procedures to the relevant department (e.g. Technical Operations, CDMO, etc.). /liliEnsure authoring of accurate, comprehensible, structured, complete and legible documents to allow timely start of development trials, process transfers and supply activities. /liliDraft the CMC documents required to enable regulatory submissions (IND/IMPD, Module3/NDA). /liliProvide technical guidance to team members and work according to appropriate SOPs, GLP, GMP, HSE and AdAcAp / Novartis guidelines. /liliProactively 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. /liliMinimum: 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. /liliFluent knowledge of English (oral and written). Desirable knowledge of site language. /liliDemonstrated success in developing formulations with an emphasis in liquid sterile dosage forms. /liliTechnical expertise and detailed understanding of drug product production and control technologies. /liliExperience with outsourcing and supervising work done by CRO/CMOs including technical overview of agreement set up. /liliExperience in writing CMC documents for regulatory submissions and responding to health authority questions. /liliGood basis of Quality Assurance (overall knowledge of GxPs). /li /ulpbWork Experience: /b /pulliFunctional Breadth. /liliOperations Management and Execution. /li /ulpbSkills: /b /pulliExperiments Design. /liliHealth And Safety (Ehs). /liliLaboratory Equipment. /liliManufacturing Process. /liliProcess Simulation. /liliProject Management. /liliSop (Standard Operating Procedure). /liliTechnical Writing. /li /ulpbLanguages : /b /ppstrongWhy Novartis: /strong 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? /ppstrongJoin our Novartis Network: /strong Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: /ppIT58 (FCRS = IT058) Advanced Accelerator Applications Italy Srl /ppFunctional Area Research Development /ppJob Type Full time /ppEmployment Type Regular /ppShift Work No /ppNovartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve. /p #J-18808-Ljbffr