Global Toxicologist (d/f/m) / Raziskovalec toksikologije (d/ž/m)

Job description

Job Description Summary The future is ours to shape. / Prihodnost je v naših rokah. Job Description As a Global Toxicologist , you will be responsible for preparation of toxicological and ecotoxicological risk assessments and for planning and managing preclinical studies in accordance with legislation, internal rules, good practices and business objectives. Your key responsibilities: Primary responsibility will be the preparation, scientific review and maintenance of Predicted No-Effect Concentration (PNEC) monographs for active pharmaceutical ingredients (APIs), including evaluation of ecotoxicological and environmental-fate data, derivation or verification of PNEC values, and maintenance of the relevant PNEC catalogues. Provide scientific support to the Sandoz Pharmaceuticals in the Environment (PiE) programme in collaboration with Global HSE, including interpretation of PNEC data for effluent risk assessments at Sandoz manufacturing sites and external API suppliers. Preparation of health hazard assessments (HHAs) for APIs for occupational safety of workers and cleaning validation (including PDE and OEL calculations), in collaboration with HSE team, and communication of outcomes to all relevant stakeholders. Preparation of less complex Ecotoxicological Risk Assessments (Module 1.6.) as per internal procedures and most recent regulatory requirements. Preparation of less complex (and cooperation in preparation of more complex) Toxicological Risk Assessments (TRAs) of various impurities and excipients (including the determination of acceptable daily intakes and/or safety risk assessment). Support genotoxicity hazard assessment for impurities using in vitro and in vivo data and in silico (Q)SAR approaches. Preparation of safety assessment of extractables & leachables (E&Ls) for qualification of materials used for primary packaging and manufacturing equipment. Peer review of less complex toxicological (risk) assessments. Providing support in planning, organization and oversight of outsourced in vitro and in vivo preclinical studies in accordance with resources, timelines, regulatory and professional standards. Adherence to GLP and other GXP standards. Active knowledge sharing within the product development organization. Active collaboration with cross-functional partners, active participation in development project teams including collaboration with external experts as indicated by project/product requirements. Implement and adhere to all the instructions and requirements of safety at work, environment protection and property protection. Responsible for personal and professional development. What you will bring to the role: University degree or PhD in life sciences (pharmacy, veterinary, medicine, biology, chemistry, biochemistry etc.). Functional knowledge of English. Knowledge of Microsoft Office. No working experience required. What we offer: Job location: Ljubljana Contract type: temporary one-year contract to cover a maternity leave, including a six-month probation period Expected weekly working hours: 40 *Pay range: €33,760 – €50,640 gross yearly * Salary at Sandoz is based on job level, qualifications, specific skills, and work experience. Fully proficient candidates are usually placed around the market median, less experienced candidates lower in the range, and those with strong or niche expertise higher. When determining placement within the range, we also consider internal pay equity and external market data. Our compensation package additionally includes: Annual bonus (STI): percentage of annual salary. Vacation allowance: in 2026 it was €2,450 net. Christmas bonus: in 2025 it was €2,100 gross. OurShare: every year, an employee of Lek d.d. will be entitled to receive shares of Sandoz AG. Voluntary Additional Pension Scheme: The company fully covers the contribution for your supplementary pension plan, amounting to 5.844% of your gross salary (the maximum annual amount is 3,224.18 EUR). Collective life and accident insurance (24/7 coverage). A hybrid work environment offering flexibility and remote work possibilities – if applicable for position. Ready for your next career move? You are kindly invited to submit your application in English and Slovene, including a CV, by September 15, 2026. Why Sandoz? Sandoz is the global leader in Biosimilar and Generic medicines, a segment of the healthcare industry that delivers 80% of the world’s medicines at 30% of the cost, touching the lives of more than 1 billion people across 100+ countries! While we are proud of our achievements, we have the ambition to do more so that everyone can benefit from the basic human right of good health. With investments in new development capabilities, production sites, new acquisitions and partnerships, we have the opportunity to shape a sustainable future for Sandoz and to help even more people gain access to low-cost, high-quality medicines. Our momentum is powered by an open, collaborative culture driven by our talented and ambitious colleagues who, in return for applying their skills, experience an agile and collegiate environment where diversity of thought is welcomed and where personal growth is supported! Join us in helping to make healthcare fairer and faster. Commitment to Diversity & Inclusion: We are committed to building an outstanding, inclusive work environment and to forming diverse teams that are representative of the patients and communities we serve. #Sandoz ------------------------------------------------------------------------------------------------------------------------------- Kot Raziskovalec toksikologije , boste odgovorni za enostavnejše toksikološke in ekotoksikološke ocene varnosti ter odgovorni za načrtovanje in upravljanje predkliničnih študij skladno z zakonodajo, internimi predpisi, dobrimi praksami in poslovnimi cilji. Vaše ključne odgovornosti: Primarna odgovornost bo priprava, strokovni pregled in vzdrževanje PNEC ( predicted no effect concentration ) monografij zdravilne učinkovine (API), vključno z vrednotenjem ekotoksikoloških podatkov in podatkov o usodi snovi v okolju, izpeljavo oziroma preverjanjem vrednosti PNEC ter vzdrževanjem ustreznih katalogov PNEC. Zagotavljanje strokovne podpore programu PiE ( Pharmaceuticals in the Environment ) v sodelovanju z globalno funkcijo HSE, vključno z interpretacijo podatkov PNEC za ocene tveganja odpadnih voda na proizvodnih lokacijah družbe Sandoz in pri zunanjih dobaviteljih zdravilnih učinkovin. Priprava manj zahtevnih ekotoksikoloških ocen tveganja (M1.6.) v skladu z internimi postopki in najnovejšimi regulativnimi zahtevami. Priprava ocen zdravstvenih tveganj (Health Hazard Assessments, HHA) za učinkovine (API) z vidika varnosti zaposlenih pri delu ter validacije čiščenja (vključno z izračuni PDE in OEL), v sodelovanju z ekipo za zdravje, varnost in okolje (HSE), ter komuniciranje rezultatov vsem relevantnim deležnikom. Priprava manj zahtevnih (ter sodelovanje pri pripravi zahtevnejših) toksikoloških ocen tveganja (Toxicological Risk Assessments, TRA) za različne nečistoče in pomožne snovi, vključno z določanjem sprejemljivih dnevnih vnosov (ADI) in/ali oceno varnostnega tveganja. Podpora pri ocenjevanju genotoksičnega tveganja nečistoč z uporabo podatkov iz in vitro in in vivo študij ter in silico pristopov ((Q)SAR). Priprava ocen varnosti izvlečkov in izlužkov (Extractables & Leachables, E&L) za kvalifikacijo materialov, ki se uporabljajo za primarno embalažo in proizvodno opremo. Strokovni pregled (peer review) manj zahtevnih toksikoloških ocen oziroma ocen tveganja. Zagotavljanje podpore pri načrtovanju, organizaciji in nadzoru zunanje izvedenih in vitro ter in vivo predkliničnih študij v skladu z razpoložljivimi viri, časovnimi okviri ter regulativnimi in strokovnimi standardi. Spoštovanje načel dobre laboratorijske prakse (GLP) in drugih standardov GxP. Aktivno deljenje znanja znotraj organizacije za razvoj izdelkov. Aktivno sodelovanje z medfunkcijskimi partnerji ter aktivna vključenost v projektne razvojne ekipe, vključno s sodelovanjem z zunanjimi strokovnjaki, kadar to zahtevajo potrebe projekta ali izdelka. Izvajanje in dosledno upoštevanje vseh navodil ter zahtev s področja varnosti pri delu, varstva okolja in zaščite premoženja. Odgovornost za osebni in strokovni razvoj. Vaš prispevek k delovnemu mestu: Visokošolska stopnja izobrazbe farmacevtske, veterinarske, medicinske, (bio)kemijske ali druge naravoslovne smeri. Aktivno znanje angleškega jezika. Poznavanje orodja Microsoft Office. Delovne izkušnje niso potrebne Kaj nudimo: Lokacija dela: Ljubljana Vrsta pogodbe: določen čas enega leta zaradi nadomeščanja porodniške odsotnosti, s 6 mesečnim poskusnim obdobjem Predvideni tedenski delovni čas: 40 ur *Plačni razpon: 33.760 – 50.640 EUR bruto letno * Plača v Sandozu temelji na nivoju delovnega mesta, kvalifikacijah, specifičnih veščinah in znanjih ter delovnih izkušnjah. Visoko usposobljeni kandidati so običajno umeščeni okoli mediane plačnega razpona, manj izkušeni na spodnji del razpona, kandidati z izrazito močnimi ali nišnimi kompetencami pa višje. Pri umeščanju v plačni razpon upoštevamo tudi notranjo uravnoteženost plač in zunanje tržne podatke . Naš paket ugodnosti dodatno vključuje: Letni bonus (STI): odstotek letne plače. Regres za letni dopust: leta 2026 je znašal 2.450 EUR (neto). Božičnica: leta 2025 je znašala 2.100 EUR (bruto). OurShare: Vsako leto bo zaposleni v družbi Lek d.d. upravičen do prejema delnic družbe Sandoz AG. Prostovoljno dodatno pokojninsko zavarovanje: družba Lek d.d. v celoti krije mesečni prispevek za dodatno pokojninsko zavarovanje v višini 5,844 % vaše mesečne bruto plače (zgornja zneskovna omejitev je 3.224,18 EUR letno). Kolektivno življenjsko in nezgodno zavarovanje (kritje velja 24/7). Hibridno delovno okolje, ki omogoča fleksibilnost in možnost dela na daljavo. – če to velja za zadevno delovno mesto. Ste pripravljeni na naslednji korak v karieri? Prijavo z življenjepisom v angleškem in slovenskem jeziku lahko oddate najpozneje do 15. septembra 2026 . Zakaj Sandoz? Sandoz je vodilni svetovni proizvajalec generičnih in podobnih bioloških zdravil – segmenta zdravstvene industrije, ki zagotavlja 80 % vseh zdravil na svetu po 30-odstotni ceni ter s tem vpliva na življenja več kot milijarde ljudi v več kot 100 državah. Čeprav smo ponosni na svoje dosežke, si prizadevamo narediti še več, da bi vsakdo imel dostop do temeljne človekove pravice – pravice do dobrega zdravja. Z naložbami v nove razvojne zmogljivosti, proizvodne lokacije, nove pridobitve in partnerstva imamo priložnost oblikovati prihodnost Sandoza ter še večjemu številu ljudi omogočiti trajnostni dostop do cenovno ugodnih in visokokakovostnih zdravil. Naš zagon temelji na odprti kulturi sodelovanja, katere srce so naši talentirani in ambiciozni sodelavci in sodelavke. V okolju, kjer so raznoliki načini razmišljanja dobrodošli in kjer se podpira osebna rast, imajo v zameno za uporabo svojih znanj možnost v celoti izkusiti delo v agilnem in povezovalnem okolju ter razvijati svojo uspešno kariero. Pridružite se nam in nam pomagajte povečati pravičnost in hitrost zdravstvenega varstva. Predani smo raznolikosti in vključenosti: Zavzemamo se za raznolikost, enake možnosti in vključenost. Prizadevamo si za oblikovanje raznolikih timov, saj ti predstavljajo naše bolnike in skupnosti, ki jih oskrbujemo. #Sandoz Skills Desired Animal Models, Bioinformatics, Collaboration, Communication Skills, Data Analysis, Ethics, Laboratory, Problem Solving, Regulatory Compliance, Research, Risk Assessment, Toxicology