Senior Expert Science & Technology – Downstream Process Development (m/f/d) - Razvoj procesov čiščenja učinkovin dodaj naslov Povzetek opisa delovnega mesta (m/ž/d) at Novartis in Mengeš

Job description

Salary Range: €46,550.00 - €86,450.00 Job Description Summary At Novartis, we are reimagining medicine by transforming breakthrough science into life-changing therapies for patients worldwide. We are the Downstream Development team focused on the early-phase development of biopharmaceutical drug substances, leveraging advanced technologies, science-based approaches, and digital solutions to design and optimize processes for manufacturing scale, contributing to the delivery of high-quality, safe, and effective medicines. As an experienced Senior Expert in our Downstream Process Development team in Mengeš, you will provide scientific and technical leadership in developing robust, scalable purification processes for next-generation biologics. Combining hands-on DSP expertise with modelling, digitalization and AI-enabled approaches, you will collaborate across functions to shape development strategies, support sound scientific decisions and advance development programs. Smo oddelek DSP, osredotočen na razvoj učinkovin, pri čemer uporabljamo napredne tehnologije, znanstveno utemeljene pristope in digitalne rešitve za načrtovanje in optimizacijo procesov za proizvodno merilo ter tako prispevamo k zagotavljanju visokokakovostnih, varnih in učinkovitih zdravil za bolnike. Kot Senior Expert v laboratorijskem razvoju procesov čiščenja bioloških učinkovin boste strokovno vodili načrtovanje, izvedbo in interpretacijo razvojnih študij v različnih fazah razvoja. Poglobljeno znanje DSP boste povezovali z modeliranjem, digitalizacijo in pristopi umetne inteligence ter v sodelovanju z medfunkcijskimi ekipami podpirali razvoj robustnih procesov, znanstveno utemeljeno odločanje in njihov uspešen prenos na pilotni nivo. Location: Mengeš, Slovenia LI#hybrid Job Description In this role, you will: Lead and coordinate downstream process development activities across assigned portfolio projects, independently managing multiple priorities and ensuring high-quality delivery within agreed timelines and project requirements. Independently design, plan, execute and document laboratory studies for the development and optimization of robust purification processes for recombinant proteins, applying a right-first-time approach. Perform and optimize DSP processes and methods, and evaluate opportunities to implement new technologies. Manage, analyze and interpret experimental data; draw scientifically sound conclusions, define follow-up studies, and lead troubleshooting for complex process challenges. Prepare high-quality protocols, technical reports, laboratory procedures, SOPs, development documentation, handover packages and regulatory-relevant deliverables. Act as DSP scientific or functional lead in local and global cross-functional project teams, providing expert recommendations and supporting evidence-based development decisions. Support process scale-up, technology transfer and implementation at internal or external manufacturing sites, including knowledge transfer and definition of process controls. Advance DSP capabilities through automation, process modelling, digitalization, data science and AI-enabled development approaches. Communicate scientific results, achievements, risks and recommendations effectively to project teams, stakeholders and external partners, and contribute to publications, patents and scientific conferences, as appropriate. Mentor colleagues, support laboratory organization and advanced DSP equipment activities, and ensure compliance with applicable quality, ethics, health, safety, environmental and information-security requirements. Education & Technical expertise PhD in Biotechnology, Biochemical or Chemical Engineering, Biochemistry, Biology, Pharmaceutical Technology or a related scientific or engineering discipline with at least 3 years of relevant experience in DSP development and/or manufacturing; alternatively, an MSc with at least 5 years of relevant experience. Strong hands-on expertise in downstream process development