Expert Science & Technology – Downstream Process Development (m/f/d) - Razvoj procesov izolacije in čiščenja bioloških učinkovin (m/ž/d)

Salary Range:

€27,160.00 - €50,440.00

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.

• Role Purpose
• As an Expert in our Downstream Process Development team in Mengeš, you will contribute scientific and technical expertise to the development of robust, scalable purification processes for next-generation biologics. Combining hands-on DSP knowledge with modelling, digitalization and AI-enabled approaches, you will work with cross-functional teams to plan and execute development studies, interpret results and support sound scientific decisions across development programs.

V Novartisu na novo osmišljamo medicino s preoblikovanjem vrhunske znanosti v terapije, ki spreminjajo življenja bolnikov po vsem svetu. Smo ekipa za razvoj procesov izolacije in čiščenja, osredotočena na zgodnje faze razvoja bioloških učinkovin. Z uporabo naprednih tehnologij, znanstveno utemeljenih pristopov in digitalnih rešitev načrtujemo ter optimiziramo procese za proizvodno merilo in tako prispevamo k zagotavljanju visokokakovostnih, varnih in učinkovitih zdravil.

Kot Expert v laboratorijskem razvoju procesov izolacije in čiščenja bioloških učinkovin boste s svojim znanstvenim in tehničnim znanjem prispevali k razvoju robustnih in skalabilnih procesov čiščenja za biološka zdravila nove generacije. Praktično znanje DSP boste povezovali z modeliranjem, digitalizacijo in pristopi umetne inteligence ter v sodelovanju z medfunkcijskimi ekipami načrtovali in izvajali razvojne študije, interpretirali rezultate in podpirali znanstveno utemeljeno odločanje.

• Location: Mengeš, Slovenia
• LI#hybrid

Job Description

In this role, you will:

• •Contribute to downstream process development activities across assigned projects, coordinating own tasks and supporting high-quality delivery within agreed timelines and project requirements.
• •Design, plan, execute and document laboratory studies for the development and optimization of robust purification processes for recombinant proteins, with guidance for more complex activities and 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, propose follow-up studies, and contribute to troubleshooting process challenges.
• •Prepare high-quality protocols, technical reports, laboratory procedures, SOPs, development documentation, handover packages and regulatory-relevant deliverables.
• •Represent DSP in local and global cross-functional project teams, providing scientific input and evidence-based recommendations within the assigned area of responsibility.
• •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.
• •Share knowledge with colleagues, support laboratory organization and 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; alternatively, an MSc with relevant experience in DSP development and/or manufacturing.
• •Hands-on knowledge of downstream process development, including process parameters, scale-down and scale-up principles, and relevant unit operations.
• •Ability to design, execute, document and interpret experiments, apply appropriate data analysis methods, contribute to troubleshooting and translate results into clear development recommendations.
• •Ability to organize own priorities and deliver high-quality results within agreed timelines while working effectively in local and global cross-functional teams.
• •Experience with or interest in data science, modelling, digital tools, automation or AI-enabled approaches in process development.
• •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; experience in knowledge sharing or coordination is an advantage.

With the selected candidate, we offer permanent employement with 6 months of probation period. Submit your application with your CV in both Slovenian and English.

Depending on the selected candidate’s knowledge, experience, competencies, and seniority, the company reserves the right to appoint the candidate to a position at a lower level than the one specified in the job posting, namely the Associate Expert Science & Technology position.

V tej vlogi boste:

• •Sodelovali pri aktivnostih razvoja procesov izolacije in čiščenja bioloških učinkovin v okviru dodeljenih projektov, usklajevali lastne naloge ter prispevali h kakovostni izvedbi v dogovorjenih rokih.
• •Načrtovali, izvajali in dokumentirali laboratorijske študije za razvoj, optimizacijo in karakterizacijo robustnih procesov čiščenja, pri zahtevnejših aktivnostih ob strokovni podpori.
• •Analizirali in interpretirali eksperimentalne podatke, oblikovali znanstveno utemeljene zaključke, predlagali nadaljnje študije ter sodelovali pri reševanju 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.
• •Zastopali področje DSP v lokalnih in globalnih medfunkcijskih projektnih ekipah ter prispevali strokovna mnenja in priporočila v okviru dodeljenega področja odgovornosti.
• •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.
• •Delili znanje s sodelavci, 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; alternativno magisterij z relevantnimi izkušnjami na področju razvoja ali proizvodnje DSP.
• •Praktično znanje razvoja procesov izolacije in čiščenja bioloških učinkovin, vključno s poznavanjem procesnih parametrov, načel povečevanja in zmanjševanja merila ter relevantnih procesnih stopenj.
• •Sposobnost načrtovanja, izvedbe, dokumentir