RLT Formulation Project Leader

Summary Create and drive formulation development with scientific & technological excellence in close collaboration with operations, analytics, engineering, 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. About the Role Role Responsibilities: Lead the development of formulations and manufacturing processes of Drug Products. Support the development and qualification of analytical methods with the AS&T team leader, following ICH guidelines and internal SOPs. Serve as formulation expert in cross-functional project teams. Be accountable for formulation and manufacturing process deliverables, including scientific documentation (Manufacturing instructions, GMP documents, deviations). Provide technical support during inspections and Health Authority requests throughout all project phases. Participate in transferring manufacturing procedures to relevant departments (e.g., Technical Operations, CDMO). Ensure accurate, comprehensible, structured, complete, and legible documentation to facilitate development trials, process transfers, and supply activities. Draft CMC documents for regulatory submissions (IND/IMPD, Module 3/NDA). Provide technical guidance to team members, adhering to SOPs, GLP, GMP, HSE, and Novartis guidelines. Proactively communicate key issues and critical topics to management, TRD DPPL, and project teams. Essential Requirements PhD in Pharmaceutics or related sciences with at least 3 years of industry experience, or Master’s degree with at least 5 years of experience. Fluent in English (oral and written); knowledge of site language is desirable. Proven success in developing liquid sterile dosage form formulations. Technical expertise in drug product production and control technologies. Experience with outsourcing and supervising CRO/CMO work, including technical overview of agreements. Experience in writing CMC documents for regulatory submissions and responding to health authority inquiries. Basic knowledge of Quality Assurance and GxPs. Why Novartis: Helping people with disease and their families requires innovative science and a passionate community. Collaborate, support, and inspire each other to achieve breakthroughs that change lives. Join us to create a brighter future together. J-18808-Ljbffr

Location: ivrea, IT

Posted Date: 5/12/2025