RLT Formulation Project Leader

Summary Create 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. 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 in accordance with ICH guidelines and internal SOPs. Participate as formulation expert in cross-functional project teams. Be accountable for all formulation and manufacturing process deliverables, including scientific documentation (Manufacturing instructions, GMP documents, deviations). Guarantee 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 authoring of accurate, comprehensible, structured, complete, and legible documents to enable timely development trials, process transfers, and supply activities. Draft CMC documents required for regulatory submissions (IND/IMPD, Module 3/NDA). Provide technical guidance to team members and ensure compliance with SOPs, GLP, GMP, HSE, and AdAcAp/Novartis guidelines. Proactively communicate key issues and critical topics to management, TRD DPPL, and relevant project team members. Essential Requirements Minimum: 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. Fluent in English (oral and written); knowledge of site language is desirable. Proven success in developing formulations, especially liquid sterile dosage forms. Technical expertise in drug product production and control technologies. Experience outsourcing and supervising CRO/CMO work, including technical oversight 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 more than science. It takes a community of passionate, collaborative individuals like you. Join us to create breakthroughs that change lives. Learn more Join our Novartis Network If this role isn't the right fit, sign up for our talent community to stay connected and hear about future opportunities: https://talentnetwork.novartis.com/network Benefits and Rewards Discover how we support your growth and well-being in our handbook . J-18808-Ljbffr

Location: ivrea, IT

Posted Date: 6/17/2025