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

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, with sound knowledge of process parameters, scale-down and scale-up principles, and integrated unit operations. Demonstrated ability to independently design, execute, document and interpret complex experiments, apply appropriate data analysis methods, troubleshoot process challenges and translate results into clear development decisions. Proven ability to manage multiple priorities and deliver high-quality results within agreed timelines, while working effectively in local and global cross-functional, matrix-based project teams. Experience with data science, modelling, digital tools or automation in process development, together with a strong interest in advancing AI-enabled approaches within the DSP team. Strong scientific and technical communication skills, with the ability to understand scientific and business needs and translate them into clear, practical recommendations and development strategies. Fluent written and spoken English, combined with a responsible, objective-driven and collaborative approach; previous scientific or technical leadership experience is an advantage. Depending on the selected candidate’s knowledge, experience, and competencies, we reserve the right to appoint the candidate to a position at a lower level than that specified in the job postin g. V tej vlogi boste: Vodili in usklajevali aktivnosti razvoja procesov izolacije in čiščenja bioloških učinkovin v okviru dodeljenih projektov ter zagotavljali kakovostno izvedbo v dogovorjenih rokih. Samostojno načrtovali, izvajali in dokumentirali laboratorijske študije za razvoj, optimizacijo in karakterizacijo robustnih procesov čiščenja, zlasti kromatografskih in filtracijskih stopenj. Analizirali in interpretirali eksperimentalne podatke, oblikovali znanstveno utemeljene zaključke, načrtovali nadaljnje študije ter vodili reševanje kompleksnih procesnih izzivov. Uporabljali modeliranje, podatkovno znanost, avtomatizacijo, digitalna orodja in pristope umetne inteligence za podporo načrtovanju procesov, povečevanju merila, vrednotenju robustnosti in odločanju. Ocenjevali nove tehnologije in razvojne pristope ter vodili njihovo smiselno uvedbo v laboratorijske procese in delovne tokove DSP. Delovali kot strokovni ali funkcijski vodja za področje DSP v lokalnih in globalnih medfunkcijskih projektnih ekipah ter zagotavljali jasna strokovna priporočila. Podpirali povečevanje merila, prenos tehnologije in uvedbo procesov na pilotnih oziroma proizvodnih lokacijah, vključno s prenosom znanja in opredelitvijo procesnih kontrol. Pripravljali kakovostne protokole, tehnična poročila, laboratorijske in standardne operativne postopke, razvojno dokumentacijo, pakete za prenos ter prispevke za regulatorne dokumente. Jasno predstavljali rezultate, tveganja in priporočila notranjim ter zunanjim deležnikom ter po potrebi prispevali k publikacijam, patentom in znanstvenim konferencam. Mentorirali sodelavce, prispevali k učinkoviti organizaciji laboratorijskega dela in zagotavljali skladnost z zahtevami kakovosti, etike, zdravja, varnosti, okolja ter informacijske varnosti. Izobrazba in tehnično strokovno znanje Doktorat s področja biotehnologije, biokemije, kemijskega ali biomedicinskega inženirstva, farmacevtske tehnologije oziroma sorodne naravoslovne ali tehniške smeri ter najmanj 3 leta relevantnih izkušenj; alternativno magisterij z najmanj 5 leti ustreznih izkušenj. Poglobljeno praktično znanje razvoja procesov izolacije in čiščenja bioloških učink