Vodilni raziskovalec v oddelku E&L (d/ž/m) / Leading Scientist in the E&L department (d/f/m)

Job Description Summary

Prihodnost je v naših rokah. / The future is ours to shape.

Job Description

Kot Vodilni raziskovalec boste imeli ključno vlogo pri razvoju zdravilnih učinkovin majhnih molekul in podobnih bioloških zdravilih, saj boste vodili in izvajali študije izvlečkov in izlužkov (Extractables and Leachables - E&L).

Vaše ključne odgovornosti:

• Načrtovanje in vodenje študij izvlečkov in izlužkov (E&L) kot del razvoja zdravil.
• Zbiranje, evalvacija in interpretacija E&L rezultatov ter oblikovanje ustreznih sklepov. Kritično vrednotenje rezultatov, celovita analiza in oblikovanje smiselnih zaključkov.
• Sodelovanje z internimi in eksternimi testnimi laboratoriji ter ustrezno usmerjanje projektne E&L strategije.
• Zagotavljanje skladnosti z industrijskimi standardi in priporočenimi pristopi pri E&L testiranju.
• Izvajanje temeljitih pregledov podatkov in dokumentiranja rezultatov. Priprava znanstveno podprtih in dobro strukturiranih E&L poročil, v skladu z načeli dobrega dokumentiranja.
• Sodelovanje v večfunkcijskih projektnih ekipah ter odgovornost za E&L aktivnosti v razvoju generičnih zdravil.
• Učinkovito sodelovanje s člani projektnih ekip, vključno s predstavljanjem ugotovitev in aktivnim sodelovanjem pri reševanju izzivov, ki se pojavijo med razvojem zdravil.
• Izvajanje projektnih aktivnosti v skladu s projektnim načrtom.
• Dokazovanje digitalne in operativne odličnosti pri svojem delu.
• Odgovornost za pripravo visokokakovostne registracijske dokumentacije za predložitev regulatornim oblastem in opravljanje vloge tehničnega strokovnjaka pri revizijah, inšpekcijskih pregledih itd.
• Aktivna vključenost pri postavljanju E&L procesov.

Vaš doprinos k delovnem mestu:

• Visokošolska izobrazba na področju naravoslovnih znanosti z dobrim znanjem s področja analitike, farmacije, kemije ali drugih sorodnih naravoslovnih znanosti.
• Minimalno 6 let ustreznih delovnih izkušenj (oziroma 3 leta v primeru doktorata znanosti) na področju razvoja ali proizvodnje zdravil.
• Zahtevano je tekoče znanje angleškega jezika (ustno in pisno) ter odlične sposobnosti znanstvenega/tehničnega pisanja.
• Znanstvena odličnost, digitalna odličnost in operativna odličnost. Sposobnost uvajanja novih pristopov ter prizadevanje za izboljšave in poenostavitve.
• Izkušnje na področju E&L ter poznavanje regulatornih zahtev in pričakovanj predstavljajo prednost, niso pa pogoj za prijavo.

Kaj nudimo:

Lokacija dela: Ljubljana

Vrsta pogodbe: pogodba za določen čas s 6-mesečnim poskusnim obdobjem

Predvideni tedenski delovni čas: 40 ur

*Plačni razpon: 50.720 – 76.080 EUR bruto

*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 2025 je znašal 2.430,99 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 5. julija 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

-------------------------------------------------------------------------------------------------------------------------------

As a Leading Scientist, you will play a critical role in the development of small molecule and biosimilar drug products by leading and executing extractables and leachables (E&L) studies.

Your key responsibilities:

• Design and lead the extractable and leachable studies as part of small molecule and biosimilar drug products development.
• Document, interpret and critically review extractable and leachable analytical results to properly guide the development of drug products.
• Work with internal and contract testing laboratories and contribute to the implementation of extractables and leachables testing strategies.
• Ensure compliance with industry standards and recommended approaches in E&L testing.
• Prepare, review, and approve technical documents, including E&L risk evaluation reports, study protocols and reports, analytical testing procedures, and other technical reports.
• Effectively function as an E&L representative on project teams and provide regular updates on the progress of E&L strategy.
• Effectively collaborate with other project team members, including presenting findings and active involvement in solving shared challenges that arise during development of the drug product.
• Fulfill other assigned project tasks and responsibilities.
• Demonstrate digital proficiency and operational excellence in your work.
• Act as a technical expert in audits, inspections, and other activities.
• Active involvement in the E&L process set-up.

What you will bring to the role:

• Advanced degree in life sciences with strong background in analytics, pharmacy, chemistry or other related Life sciences.
• Minimum 6 years of relevant experience (or 3 years in case of PhD) in research & development or production.
• Fluent knowledge of the English language and excellent scientific/technical writing skills.
• Scientific Excellence, Digital Excellence and Operational Excellence. Ability to implement new approaches and strives for improvement and simplifications
• Experience with E&L testing (from wet chemistry sample preparation to Mass spectroscopy using GC and LC methods) and understanding of the regulatory expectations and requirements is a plus.

What we offer:

Job location: Ljubljana

Contract type: temporary (fixed-term) contract with 6-month probation period

Expected weekly working hours: 40

*Pay range: €50,720 – €76,080 gross

*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 2025 it was €2,430.99 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 July 5th, 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

Analysis, Analysis, Analytical Chemistry, Analytical Skill, Automated Process, Chemical Analysis, Chemical Laboratory, Chemical Synthesis, Chemistry, Data Analysis, Diversity & Inclusion, Drug Development, Drug Discovery, Emotional Intelligence (EQ), Employee Development, Graph Algorithms, HPLC (High-Performance Liquid Chromatography), Innovation, Innovative Medicines, Machine Learning Algorithms, Medical Research, Medicinal Chemistry, Molecular Biology, Molecular Modelling, Organic Chemistry {+ 9 more}