PJoin to apply for the RLT Drug Product Project Leader role at Novartis Italia /ppJoin to apply for the RLT Drug Product Project Leader role at Novartis Italia /ppbRole Purpose /b /ppLeads and manages all Drug Product (DP) project activities linked to the development of radiopharmaceutical parenteral, both ready to use and freeze-dried products. Supports coaches team members, participates in scientific teams and contributes to the overall Technical Research and Development (TRD) strategies and goals. Designs, plans, performs, interprets, and reports the results of scientific experiments for the preparation and timely delivery of drug product. /ppSummary /ppbRole Purpose /b /ppLeads and manages all Drug Product (DP) project activities linked to the development of radiopharmaceutical parenteral, both ready to use and freeze-dried products. Supports coaches team members, participates in scientific teams and contributes to the overall Technical Research and Development (TRD) strategies and goals. Designs, plans, performs, interprets, and reports the results of scientific experiments for the preparation and timely delivery of drug product. /ppAbout The Role /ppbRole Responsibilities : /b /pulliLeads and manages all formulation and process development activities for assigned projects. /liliSupport the development and the qualification of analytical methods together with the AST team leader in accordance with ICHs guidelines and internal SOPs. /liliRepresents DP project teams in TRD sub-team, with strong sense of accountability and responsibility. /liliDevelops sound DP project strategy including contingency planning and risk assessments in line with the overall TRD project plan, development guidelines (as applicable), SOPs and TRD / RLT strategy. /liliMonitors project plans and ensures timely availability of agreed deliverables. Proactively communicates overall project strategy, key issues, and any other critical topics in a timely manner to the appropriate management level, to the TRD project leader and / or to any other relevant project team member(s). /liliEnsures adherence to the EP / LP project review process through relevant governance boards. No delays or missed reviews due to poor planning. Full compliance to other governance board processes, e.g. DMC. Ensure high quality documentation and pre-reads are provided per guidelines to facilitate these reviews. /liliEnsures support to due diligence as applicable. Ensures availability of pre-requisites for transfer of projects to other sites as applicable (e.g. licenses, equipment, resource plan). /liliEnsures application of IP process for all projects assigned and that all IP is accurately captured. /liliEnsures contribution to respective Network deliverables and cross-functional workstreams / initiatives and ensure sharing of actions and learnings across global teams. /liliMinimum : PhD in Pharmaceutics or related sciences with a minimum of 6 years of proven experience within the pharmaceutical / biotech industry or a Master’s degree with a minimum of 8 years experience. /liliFluent knowledge of English (oral and written). Desirable knowledge of site language. /liliBroad and profound understanding of development activities and processes in pharmaceutical sciences. (early phase and late phase development) /liliExcellent knowledge of laboratory and / or technical tools (e.g. Quality by Design, statistical software, Process Analytical Technology). /liliStrong experience with outsourcing and supervising work done by CRO / CMOs including technical overview of agreement set up. /liliStrong experience in writing CMC documents for regulatory submissions and responding to health authority questions. /liliSolid understanding of relevant GLP, GMP regulations and policies. /liliStrong presentation skills and scientific / technical writing skills. /li /ulpCommitment to Diversity and Inclusion : Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve. /ppuWhy Novartis : /u 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? our Novartis Network : 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 : and Rewards : Read our handbook to learn about all the ways we’ll help you thrive personally and professionally : /ppSeniority level /ppSeniority level /ppMid-Senior level /ppEmployment type /ppEmployment type /ppFull-time /ppJob function /ppJob function /ppProduct Management and Marketing /ppPharmaceutical Manufacturing /ppReferrals increase your chances of interviewing at Novartis Italia by 2x /ppSign in to set job alerts for “Lead Product Manager” roles. /ppRLT Analytical Product Project Leader (m / f / d) /ppbCastagneto Po, Piedmont, Italy 2 weeks ago /b /ppWe’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. /ppJ-18808-Ljbffr /p #J-18808-Ljbffr