H3Summary /h3 pCreate and drive formulation development with scientific and technological excellence in close collaboration with operations, analytics, engineering, and relevant SMEs, QA, and the project DPPL. Development activities include formulation and process design, control strategy, quality risk management, authoring development documents, and manufacturing instructions for technical and GMP manufacturing, including deviation handling. /p h3About The Role /h3 h3Role Responsibilities: /h3 ol liLead the development of formulations and manufacturing processes of Drug Products. /li liSupport the development and qualification of analytical methods with the AST team leader in accordance with ICH guidelines and internal SOPs. Participate as formulation expert in cross-functional project teams. /li liBe accountable for all formulation and manufacturing process deliverables, including scientific documentation (Manufacturing instructions, GMP documents, deviations). /li liGuarantee technical support during inspections and Health Authority requests throughout all project phases. /li liParticipate in transferring manufacturing procedures to relevant departments (e.g., Technical Operations, CDMO). /li liEnsure authoring of accurate, comprehensible, structured, complete, and legible documents to enable timely development trials, process transfers, and supply activities. /li liDraft CMC documents required for regulatory submissions (IND/IMPD, Module 3/NDA). /li liProvide technical guidance to team members and ensure compliance with SOPs, GLP, GMP, HSE, and AdAcAp/Novartis guidelines. /li liProactively communicate key issues and critical topics to management, TRD DPPL, and relevant project team members. /li /ol h3Essential Requirements /h3 ol liMinimum: PhD in Pharmaceutics or related sciences with at least 3 years of experience in the pharmaceutical/biotech industry, or Master’s degree with at least 5 years of experience. /li liFluent in English (oral and written); knowledge of site language is desirable. /li liProven success in developing formulations, especially liquid sterile dosage forms. /li liTechnical expertise in drug product production and control technologies. /li liExperience outsourcing and supervising CRO/CMO work, including technical oversight of agreements. /li liExperience in writing CMC documents for regulatory submissions and responding to health authority inquiries. /li liBasic knowledge of Quality Assurance and GxPs. /li /ol h3Why Novartis /h3 pHelping people with disease and their families requires more than science. It takes a community of passionate, collaborative individuals like you. Join us to create breakthroughs that change lives. a Learn more /a /p h3Join our Novartis Network /h3 pIf this role isn't the right fit, sign up for our talent community to stay connected and hear about future opportunities: /p h3Benefits and Rewards /h3 pDiscover how we support your growth and well-being in our a handbook /a. /p #J-18808-Ljbffr