Senior Scientist IVIVC (d/f/m) / Raziskovalec ekspert IVIVC (d/ž/m)

We are Sandoz Global Development organization, responsible for development & delivery of generic products with high value for patients. We are looking for a scientist who will join the In-vitro & in-vivo (IVIVC) correlation group in Pharmaceutical Research Department SDC Slovenia. IVIVC team oversees development of in-vitro approaches such as dissolution and permeability tests to predict pharmacokinetic response and in-vitro potency assays to estimate the efficacy and similarity of complex drug substances (e. g. oligonucleotides, peptides and iron products).

We are highly motivated and skilled experts, and we are looking for scientist who will support development and management of various in-vitro methods (dissolution, potency assays) to both characterization and specification purposes of generic complex products. Your Key ResponsibilitiesYour responsibilities include, but not limited to: Provision of knowledge in preformulation, physico-chemical characterization, stability, bioavailability/pharmacokinetics of molecules to aid generic product development. Develop and optimization of quality control (QC) and biorelevant dissolution methods mimicking the physiological systems. Independent interpretation of experimental results of in-vitro testing vs.

formulation/process changes, and identification of the critical material attributes (CMA) and critical process parameters (CPP), which are expected to affect bioavailability and bioequivalence. Development of other in-vitro assays capturing in-vivo behavior of products such as permeability, bioassays, IVRT testing of different dosage forms (e. g. gels, suspensions, creams/ointments). Qualification and transfer of QC dissolution method into GMP environment. Preparation of scientific reports and documents; coordinates and deliver high-quality source documents for submission, review of regulatory documents; provides content to health authorities questions. Generate/revise protocols/reports, SOPs, forms, laboratory data sheets, mentoring and support to lab associates.

Good communication with external partner laboratories & effective interacting within project teams as well as presentation of results. Work according to and ensure compliance with regulatory requirements, quality & HSE standards. What You Will Bring To The RoleAdvanced degree (desirable PhD) in pharmacy, biochemistry, molecular biology or other relevant discipline. Scientific and practical experience in biopharmaceutics, formulation development, and dissolution field (e. g. at least 2 years of experience).

Strong soft skills, means the ability to communicate in an open, clear, assertive, organized, and concise manner to be influential in scientific meetings and ability to work together as one team in a global environment. Active knowledge of English language required (oral & written). You’ll ReceiveEmployment at the most reputable employer in Slovenia offers Competitive salary, Annual bonus, Flexible working schedule, tailored to your needs, possibility to work from home, Pension scheme, Employee Recognition Scheme, Expanded program for the promotion of health in the field of physical, mental and social well-being (Energized for Life), Unlimited learning and development opportunities.

Possible job locations: Slovenia (Ljubljana)We offer permanent contract with 6-month of probation period. You are kindly invited to submit your application in English language, including CV, by 22. 07. 2025. Why Sandoz?Generic and Biosimilar medicines are the backbone of the global medicines industry. In delivering over 900 million treatments with Sandoz medicines to patients around the world, 20,000 people of more than 100 nationalities are involved.

While we are proud of this achievement, we have an ambition to do more!With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.

Our momentum and entrepreneurial spirit 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 with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged!The future is ours to shape!Commitment To Diversity & InclusionSandoz is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve. #Sandoz_________________________________________________________________________Smo Sandozov globalni razvojni center, odgovorni za razvoj in dostavo generičnih izdelkov, pomembnih za bolnike.

Iščemo Raziskovalca eksperta, ki se bo pridružil skupini za in-vitro in in-vivo (IVIVC) korelacije v Oddelku za farmacevtski razvoj SDC Slovenija. Skupina IVIVC vodi razvoj in-vitro pristopov, kot so testi raztapljanja in prepustnosti, za napoved farmakokinetičnega odziva ter in-vitro testi učinkovitosti za oceno učinkovitosti in podobnosti kompleksnih zdravilnih učinkovin (npr. oligonukleotidi, peptidi in železovi pripravki). Smo visoko motivirani in usposobljeni strokovnjaki in iščemo raziskovalca, ki bo podpiral razvoj in upravljanje različnih in-vitro metod (testi raztapljanja, testi učinkovitosti) za potrebe karakterizacije in specifikacije generičnih kompleksnih izdelkov.

Vaše Ključne OdgovornostiVaše odgovornosti vključujejo, vendar niso omejene na: Zagotavljanje znanja s področja preformulacije, fizikalno-kemijske karakterizacije, stabilnosti, biološke uporabnosti/farmakokinetike molekul za podporo razvoju generičnih izdelkov. Razvoj in optimizacija metod raztapljanja za kontrolo kakovosti (QC) in biorelevantnih metod, ki posnemajo fiziološke sisteme. Samostojna interpretacija eksperimentalnih rezultatov in-vitro testiranja glede na spremembe formulacije/procesa ter identifikacija kritičnih lastnosti materialov (CMA) in kritičnih procesnih parametrov (CPP), ki lahko vplivajo na biološko uporabnost in bioekvivalenco.

Razvoj drugih in-vitro testov, ki zajemajo in-vivo vedenje izdelkov, kot so testi prepustnosti, bioanalize, IVRT testiranje različnih farmacevtskih oblik (npr. geli, suspenzije, kreme/mazila). Kvalifikacija in prenos QC metode raztapljanja v GMP okolje. Priprava znanstvenih poročil in dokumentov; koordinacija in dostava kakovostnih izvornih dokumentov za regulativne oddaje; priprava odgovorov na vprašanja zdravstvenih organov. Priprava/posodabljanje protokolov/poročil, SOP-jev, obrazcev, laboratorijskih listov; mentorstvo in podpora laboratorijskim sodelavcem. Dobra komunikacija z zunanjimi partnerskimi laboratoriji in učinkovito sodelovanje v projektnih skupinah ter predstavitev rezultatov. Delo v skladu z regulativnimi zahtevami ter standardi kakovosti in varnosti (HSE).

Vaš Doprinos k Delovnem MestuUniverzitetna izobrazba (zaželen doktorat) iz farmacije, biokemije, molekularne biologije ali druge ustrezne smeri. Znanstvene in praktične izkušnje na področju biofarmacevtike, razvoja formulacij in raztapljanja (npr. vsaj 2 leti izkušenj). Mehke veščine – sposobnost odprte, jasne, samozavestne, organizirane in jedrnate komunikacije ter vplivanja na znanstvenih sestankih; sposobnost timskega dela v globalnem okolju. Aktivno znanje angleškega jezika (govorno in pisno).

Kaj NudimoZaposlitev pri najuglednejšem delodajalcu v Sloveniji vam prinaša konkurenčen plačni paket, letni bonus, fleksibilen način dela z možnostjo prilagajanja urnika in delom od doma, pokojninsko shemo, shemo nagrajevanja in priznanja dosežkov, razširjeni program promocije zdravja na področju telesnega, duševnega in družbenega počutja (Polni življenja) ter dogodke, neomejene priložnosti za učenje in razvoj. Možne lokacije dela: Slovenija (Ljubljana)Z izbranim kandidatom bomo sklenili delovno razmerje za nedoločen čas s poskusno dobo 6 mesecev.

Prijave z življenjepisom v angleškem in slovenskem jeziku lahko oddate najkasneje do 22. 07. 2025 preko spletne povezave. Zakaj Sandoz in Lek?Generična in podobna biološka zdravila so hrbtenica svetovne industrije zdravil. Pri zagotavljanju več kot 900 milijonov terapij s Sandozevimi zdravili bolnikom po vsem svetu, sodeluje 20. 000 ljudi več kot 100 narodnosti.

Na ta dosežek smo ponosni, a si želimo še več!Z naložbami v nove razvojne zmogljivosti, najsodobnejše proizvodne lokacije, nove pridobitve in partnerstva imamo priložnost oblikovati prihodnost Sandoza in Leka ter še večjemu številu bolnikov omogočiti trajnostni dostop do cenovno ugodnih in visokokakovostnih zdravil. Naša zagon in podjetniški duh temeljita na odprti kulturi sodelovanja, katere srce so naši talentirani in ambiciozni sodelavci ter sodelavke.

V okolju, kjer je raznolikost dobrodošla in kjer se spodbuja osebna rast, imajo v zameno za uporabo svojih znanj, možnost v celoti izkusiti delo v agilnem in povezovalnem okolju in z možnostjo fleksibilnega in hibridnega dela razvijati svojo kariero. Prihodnost je v naših rokah!Predani Smo Raznolikosti In VključenostiSandoz se zavzema za raznolikost, enake možnosti in vključenost. Prizadevamo si za oblikovanje raznolikih timov, saj ti predstavljajo naše bolnike in skupnosti, ki jih oskrbujemo. #Sandoz