Vodja laboratorija za Bioanalize (d/ž/m) / Quality Team Lead Bioanalytical laboratory (d/f/m)

Job DescriptionPridružite se nam kot Vodja laboratorija za Bioanalize v Visokotehnološkem centru za proizvodnjo učinkovin za podobna biološka zdravila v Lendavi, kjer boste imeli ključno vlogo pri vodenju in strateškem razvoju laboratorija ter zagotavljanju nemotenega izvajanja kontrolnih aktivnosti.Vaša odgovornost bo obsegala upravljanje ekipe, razvoj mikrobioloških procesov in skrb za skladnost z zakonodajo, internimi predpisi, dobrimi praksami ter poslovnimi cilji. S svojim znanjem boste zagotavljali visoko kakovost storitev za naše kupce, hkrati pa spodbujali kulturo stalnih izboljšav in operativne odličnosti.Vaše Ključne OdgovornostiVodenje in strateški razvoj bioanalitskega laboratorija za zagotavljanje nemotenega vsakodnevnega delovanja ter skladnosti z zahtevami cGxP regulative.Nadzor nad izvajanjem bioanalitskih metod, vključno z biološkimi testi s celičnimi kulturami, ELISA (Enzyme-Linked Immunosorbent Assay) ter kolorimetričnimi metodami za kvantifikacijo beljakovin.Delo s humanimi celičnimi linijami: priprava celičnih bank, gojenje celic ter priprava vzorcev za analitske postopke.Priprava in pregled validacijskih protokolov, poročil, standardnih operativnih postopkov (SOP) ter druge dokumentacije za potrebe in-vitro bioekvivalenčnih in karakterizacijskih študij.Zagotavljanje skladnosti z dobrimi laboratorijskimi praksami (GLP) ter zakonodajo Republike Slovenije, EU, FDA in drugimi relevantnimi regulatornimi zahtevami. Aktivna podpora pri notranjih in zunanjih presojah ter inšpekcijskih pregledih.Vodenje preiskav odstopanj, OOX rezultatov in reklamacij ter sodelovanje pri oblikovanju in izvajanju korektivnih in preventivnih ukrepov (CAPA).Spodbujanje kulture stalnih izboljšav in operativne odličnosti znotraj laboratorija.Upravljanje usposabljanj, spremljanje uspešnosti ter strokovni razvoj članov ekipe v skladu z zahtevami cGxP.Usklajevanje operativnih aktivnosti oddelka ter nudenje strokovne bioanalitske podpore proizvodnji, razvoju in regulativnim zadevam.Vaš Doprinos k Delovnem MestuVisokošolska izobrazba farmacevtske, biološke, kemijske, mikrobiološke ali druge naravoslovne smeri.Najmanj 3 leta izkušenj na področju laboratorijskih procesov, po možnosti v reguliranem okolju.Dobro poznavanje načel cGxP in GLP ter izkušnje z zagotavljanjem skladnosti z EU in FDA regulative.Praktične izkušnje z bioanalitskimi metodami, kot so ELISA, kolorimetrične metode za kvantifikacijo beljakovin ter tehnike celičnih kultur.Dokazane sposobnosti priprave in pregleda validacijskih protokolov, SOP-jev ter regulativne dokumentacije.Izrazite vodstvene sposobnosti in izkušnje z vodenjem ekip ter spodbujanjem kulture stalnih izboljšav.Odlične sposobnosti reševanja problemov, vključno z obravnavo odstopanj, OOX rezultatov in procesov CAPA.Aktivno znanje angleškega jezika ter dobro poznavanje orodij Microsoft Office.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 (DobroBit) ter dogodke, neomejene priložnosti za učenje in razvoj.Lokacija dela: Lendava, SlovenijaZ 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 30. 11. 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.#BIORampUp Sandoz_________________________________________________________________________________________________________________________Join us as Quality Team Leader of Bioanalytical Laboratory, where you will play a key role in leading and strategically developing the laboratory while ensuring smooth execution of control activities.You will be responsible for managing the team, developing microbiological processes and maintaining compliance with legislation, internal standards, best practices and business objectives. Your expertise will ensure high-quality services for our customers while fostering a culture of continuous improvement and operational excellence.Your Key ResponsibilitiesYour responsibilities include, but not limited to:Lead and strategically develop the Bioanalytical Laboratory to ensure smooth daily operations and compliance with cGxP regulatory requirements.Oversee the execution of bioanalytical methods, including biological assays with cell cultures, ELISA (Enzyme-Linked Immunosorbent Assay) and colorimetric methods for protein quantification.Work with cell lines: preparation of cell banks, cell cultivation and sample preparation for analytical procedures.Prepare and review validation protocols, reports, standard operating procedures (SOPs) and other documentation for in-vitro bioequivalence and characterization studies.Ensure compliance with Good Laboratory Practices (GLP) and regulations of Slovenia, the EU, FDA and other relevant authorities. Provide active support during internal and external audits and inspections.Lead investigations of deviations, OOX results and complaints, and contribute to the design and implementation of corrective and preventive actions (CAPA).Promote a culture of continuous improvement and operational excellence within the laboratory.Manage training, monitor performance and support the professional development of team members in line with cGxP requirements.Coordinate departmental operational activities and provide expert bioanalytical support to manufacturing, development, and regulatory affairs.What You Will Bring To The RoleUniversity degree in pharmacy, biology, chemistry, microbiology or another natural science discipline.Minimum 3 years of experience in laboratory operations, preferably in a regulated environment.Understanding of cGxP and GLP principles, with experience ensuring compliance with EU and FDA regulations.Hands-on experience with bioanalytical methods such as ELISA, colorimetric protein quantification and cell culture techniques.Proven ability to prepare and review validation protocols, SOPs and regulatory documentation.Strong leadership skills with experience managing teams and driving continuous improvement initiatives.Excellent problem-solving skills, including handling deviations, OOX results and CAPA processes.Proficiency in English and good knowledge of Microsoft Office tools.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 (WellBeat), Unlimited learning and development opportunities.Job location: Lendava, SloveniaWe offer permanent contract with 6-month of probation period. You are kindly invited to submit your application in English language, including CV, by November 30th, 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.#BIORampUp Sandoz