Bioassay Lab: Senior QC Specialist (d/f/m) / Višji specialist kontrole kakovosti (d/ž/m)

Job Description Summary

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

Job Description

At Sandoz, we are building a state-of-the-art biopharmaceutical manufacturing site in Lendava and are looking for talented professionals who want to help shape its future. As a (Senior) QC Specialist within the Bioassay Laboratory, you will play a key role in establishing laboratory capabilities, supporting analytical method transfers, and ensuring the quality of biological medicines.

The Bioassay Laboratory is responsible for performing bioassays used to assess the biological activity of drug substances and drug products. The role involves working with cell cultures, cell-based assays, immunological techniques such as ELISA, and supporting the transfer, validation and lifecycle management of analytical methods within a GMP environment.

This is more than a traditional laboratory role. We are looking for a subject matter expert who is motivated by the opportunity to help establish a new laboratory, shape processes, and contribute to building a high-performing team in a growing biopharmaceutical organisation.

Key Responsibilities

• Perform and scientifically evaluate bioassay testing to assess the biological activity of drug substances and drug products.
• Work with cell cultures, maintain cell lines, and prepare biological materials required for analytical testing.
• Support analytical method transfers, validations, troubleshooting activities, and continuous method improvement in compliance with GMP requirements.
• Review, approve and interpret analytical results used for batch release and stability testing.
• Lead or support investigations related to deviations, OOS, OOT and other atypical results, including root cause analysis and CAPA implementation.
• Prepare, review and maintain laboratory documentation, including SOPs, work instructions, protocols, reports and validation documents.
• Participate in internal and external inspections, audits and regulatory interactions.
• Contribute to the implementation of laboratory equipment, systems and best practices, ensuring operational readiness and compliance.
• Provide technical guidance and day-to-day support to laboratory colleagues in resolving analytical and operational challenges.
• Play an active role in the establishment and continuous improvement of the Bioassay Laboratory.

What You'll Bring to the Role

• University degree (Master's level or equivalent) in Biology, Biochemistry, Biotechnology, Microbiology, Biomedical Laboratory Science or another relevant scientific discipline.
• Minimum of 2 years of experience in a GMP environment; for the Senior level, at least 5 years of relevant experience.
• Experience gained within the pharmaceutical, biopharmaceutical or another highly regulated industry.
• Hands-on experience with cell culture techniques, cell-based assays, ELISA or other immunological methods is highly desirable.
• Experience with analytical method transfer, validation or optimisation would be considered an advantage.
• Sound understanding of GMP requirements and laboratory documentation practices.
• Good command of English, both written and spoken.
• Proficiency in working with laboratory and digital systems.
• Strong analytical thinking, attention to detail and problem-solving skills.
• High level of accountability, integrity and ability to work both independently and collaboratively.
• Proactive mindset, learning agility and a passion for continuous improvement.

What we offer:

Job location: Lendava, Slovenia

Contract type: permanent contract with 6-month probation period

Expected weekly working hours: 40

Pay range* (annual gross salary): €45.120,00 - €67.680,00

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 October 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.

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

________________________________________________________________________________

V Lendavi vzpostavljamo sodoben biofarmacevtski proizvodni center in iščemo nove sodelavce, ki želijo soustvarjati nekaj novega. Kot (Senior) Specialist za kontrolo kakovosti (QC) v bioanalitskem laboratoriju boste imeli pomembno vlogo pri vzpostavitvi laboratorija, prenosu analitskih metod ter zagotavljanju kakovosti bioloških zdravil.

Bioanalitski laboratorij je odgovoren za izvajanje bioassay metod, s katerimi preverjamo biološko aktivnost učinkovin in končnih izdelkov. Delo vključuje rokovanje s celičnimi kulturami, izvajanje celično temelječih testov, imunoloških metod (npr. ELISA) ter sodelovanje pri prenosu in validaciji analitskih metod v GMP okolju.

To ni klasična laboratorijska vloga. Iščemo strokovnjaka, ki želi aktivno sodelovati pri vzpostavitvi novega laboratorija, oblikovanju procesov ter prenosu znanja in najboljših praks v hitro rastočem biofarmacevtskem okolju.

Vaše ključne odgovornosti:

• Izvajanje in strokovno vrednotenje bioanalitskih metod za preverjanje biološke aktivnosti učinkovin in končnih izdelkov.
• Delo s celičnimi kulturami, vzdrževanje celičnih linij ter priprava materialov za izvajanje analitskih metod.
• Podpora pri prenosu, validaciji in optimizaciji bioanalitskih metod ter zagotavljanje njihove skladnosti z GMP zahtevami.
• Pregled, odobritev in interpretacija rezultatov analiz za potrebe sproščanja serij in stabilnostnega testiranja.
• Aktivno sodelovanje pri obravnavi odstopanj (OOS/OOT/OOX), analizi vzrokov ter izvajanju korektivnih in preventivnih ukrepov (CAPA).
• Priprava, pregled in posodabljanje laboratorijske dokumentacije (SOP, delovna navodila, validacijska dokumentacija, protokoli in poročila).
• Sodelovanje pri internih in zunanjih inšpekcijah ter regulatornih pregledih.
• Aktivna vloga pri vzpostavljanju laboratorijskih procesov, uvajanju opreme, digitalnih sistemov in najboljših laboratorijskih praks.
• Strokovna podpora sodelavcem pri vsakodnevnem delu ter reševanju tehničnih in analitskih izzivov.

Vaš doprinos k delovnem mestu:

• Zaključena najmanj 2. bolonjska stopnja s področja biologije, biokemije, biotehnologije, mikrobiologije, laboratorijske biomedicine ali sorodnega naravoslovnega področja.
• Najmanj 2 leti izkušenj v GMP okolju; za senior raven vsaj 5 let relevantnih izkušenj.
• Izkušnje iz farmacevtskega, biofarmacevtskega ali drugega reguliranega laboratorijskega okolja.
• Zaželene praktične izkušnje z delom s celičnimi kulturami, celično temelječimi testi, ELISA ali drugimi imunološkimi metodami.
• Poznavanje prenosa, validacije ali optimizacije analitskih metod predstavlja prednost.
• Dobro razumevanje zahtev dobre proizvodne prakse (GMP) in laboratorijske dokumentacije.
• Aktivno znanje angleškega jezika (pisno in ustno).
• Dobro poznavanje dela z računalniškimi sistemi in laboratorijsko programsko opremo.
• Visoka stopnja odgovornosti, natančnosti in integritete ter sposobnost samostojnega odločanja in reševanja problemov.
• Proaktivnost, želja po učenju ter sposobnost učinkovitega sodelovanja v interdisciplinarnih timih.

Kaj nudimo:

Lokacija dela: Lendava, Slovenija

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

Predvideni tedenski delovni čas: 40 ur

Plačni razpon* (letna bruto plača): 45.120,00 - 67.680,00 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 15. oktobra 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

Skills Desired