AS&T Specialist (d/f/m)

Job Description Summary Prihodnost je v naših rokah. / The future is ours to shape. Job Description Iščemo AS&T specialista , ki bo zagotavljal strokovno analitsko podporo biofarmacevtskim izdelkom, procesom in projektom. Odgovorni boste za načrtovanje, izvedbo, dokumentiranje in vrednotenje analitskih študij, vključno z razvojem, optimizacijo, verifikacijo, validacijo in prenosom analitskih metod ter stabilnostnimi študijami. Z interpretacijo rezultatov in pripravo kakovostne dokumentacije boste zagotavljali pravočasno podporo kontrolnim, proizvodnim in razvojnim procesom. Pri delu boste tesno sodelovali s funkcijami QC, QA, proizvodnjo, razvojem in drugimi internimi ter zunanjimi partnerji. Sodelovali boste pri uvajanju novih izdelkov, metod, tehnologij in procesov, preiskovanju analitskih odstopanj ter izvajanju izboljšav v skladu z zahtevami GMP in veljavnimi regulativnimi standardi. Vaše ključne odgovornosti: Načrtovanje, izvajanje in dokumentiranje analitskih aktivnosti, vključno z razvojem, optimizacijo, validacijo, verifikacijo in prenosom analitskih metod. Izvajanje stabilnostnih študij ter interpretacija in poročanje analitskih rezultatov. Priprava in pregled strokovne ter GMP dokumentacije, vključno s protokoli, poročili, SOP-i, specifikacijami in ocenami tveganja. Podpora pri uvajanju novih biofarmacevtskih izdelkov, procesov, analitskih metod in tehnologij v proizvodnjo. Preiskovanje analitskih odstopanj, vključno z OOS in OOT, ter sodelovanje pri izvajanju CAPA ukrepov. Sodelovanje pri obvladovanju sprememb (change control), izboljšavah procesov ter zagotavljanju skladnosti z GMP in regulatornimi zahtevami. Tesno sodelovanje s QC, QA, proizvodnjo, razvojem ter drugimi internimi in zunanjimi partnerji. Strokovna podpora pri laboratorijski opremi, inšpekcijah in revizijah ter aktivno prispevanje k varnemu in kakovostnemu delovnemu okolju. Vaš doprinos k delovnemu mestu: Univerzitetna izobrazba s področja farmacije, kemije, biokemije, biotehnologije ali sorodne naravoslovne smeri. Izkušnje na področju analitike, AS&T, QC ali razvoja, prednostno v farmacevtskem ali biofarmacevtskem okolju. Poznavanje analitskih metod in GMP zahtev; znanje s področja bioloških zdravil predstavlja prednost. Dobro znanje angleškega jezika ter sposobnost sodelovanja v interdisciplinarnem okolju. Kaj nudimo: Lokacija dela: Lendava Vrsta pogodbe: nedoločen čas s 6-mesečnim poskusnim obdobjem Predvideni tedenski delovni čas: 40 ur Plačni razpon (letna bruto plača): 30.960 – 46.440 EUR * 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 Kolektivno življenjsko in nezgodno zavarovanje (kritje velja 24/7) Hibridno delovno okolje, ki omogoča fleksibilnost in možnost dela na daljavo. Ste pripravljeni na naslednji korak v karieri? Prijavo z življenjepisom v angleškem in slovenskem jeziku lahko oddate najpozneje do 29. novembra 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. Prihodnost je v naših rokah. 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 ____________________________________________________ We are looking for an AS&T Specialist to provide scientific and analytical support for biopharmaceutical products, processes and projects. You will be responsible for planning, executing, documenting and evaluating analytical studies, including the development, optimization, verification, validation and transfer of analytical methods, as well as stability studies. Through the interpretation of analytical results and preparation of high-quality documentation, you will ensure timely and reliable support for quality control, manufacturing and development activities. In this role, you will work closely with QC, QA, Manufacturing, Development and other internal and external stakeholders. You will support the introduction of new products, analytical methods, technologies and processes, investigate analytical deviations and contribute to continuous improvements in compliance with GMP and applicable regulatory requirements. Your key responsibilities: Plan, execute and document analytical activities, including the development, optimization, validation, verification and transfer of analytical methods. Perform stability studies and interpret, evaluate and report analytical results. Prepare and review technical and GMP documentation, including protocols, reports, SOPs, specifications and risk assessments. Support the introduction of new biopharmaceutical products, processes, analytical methods and technologies into manufacturing. Investigate analytical deviations, including OOS and OOT results, and support the implementation of CAPA actions. Participate in change control activities and process improvements while ensuring compliance with GMP and applicable regulatory requirements. Collaborate closely with QC, QA, Manufacturing, Development and other internal and external stakeholders. Provide technical support related to laboratory equipment, inspections and audits, while actively contributing to a safe and quality-focused working environment. What you’ll bring to the role: University degree in Pharmacy, Chemistry, Biochemistry, Biotechnology or another relevant scientific discipline. Previous experience in analytical development, AS&T, QC or Development, preferably within the pharmaceutical or biopharmaceutical industry. Knowledge of analytical methods and GMP requirements; experience with biologics is an advantage. Good command of English and the ability to work effectively in a cross-functional environment. What we offer: Job location: Lendava Contract type: permanent contract with 6-month probation period Expected weekly working hours: 40 *Pay range: 30.960 – 46.440 EUR gross annually * 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 Collective life and accident insurance (24/7 coverage) A hybrid work environment offering flexibility and remote work possibilities Ready for your next career move? You are kindly invited to submit your application in English and Slovene, including a CV, by November 29, 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. The future is ours to shape. 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 Skills Desired