Job Description Summary

Job Description

V Leku gradimo prihodnost biofarmacije. Na ljubljanski lokaciji nastaja eden največjih in tehnološko najnaprednejših biofarmacevtskih centrov za razvoj in proizvodnjo bioloških zdravil, ki bo pomembno prispeval k dostopnosti sodobnih terapij za paciente po svetu. V okviru širitve naših zmogljivosti iščemo sodelavce, ki želijo sodelovati pri ustvarjanju inovativnega in mednarodnega okolja ter soustvarjati razvoj ene najhitreje rastočih panog v farmacevtski industriji.

Za okrepitev naše ekipe na področju tehnologije proizvodnih procesov iščemo več novih sodelavcev in sodelavk, s predvidenim začetkom zaposlitve v letu 2027.

K prijavi vabimo izkušene strokovnjake in kandidate z manj izkušnjami, ki že imajo osnovno strokovno znanje ter praktične izkušnje na področju bioprocesov, farmacevtske proizvodnje ali sorodnih področij in želijo svoje znanje nadgraditi na področju biofarmacije.

Vaše ključne odgovornosti:

• Sodelovanje pri vzpostavitvi najsodobnejšega upstream procesa (USP), vključno z izborom ustrezne opreme, pripravo uporabniških zahtev (URS), sodelovanjem z dobavitelji ter podporo pri izvedbi testiranj, zagonov in validacij opreme in procesov.
• Prispevanje k razvoju tehnološke dokumentacije, definiranju procesnih parametrov in receptur ter zagotavljanje robustnega in skladnega vodenja USP procesa z uporabo avtomatiziranih sistemov po postavitvi novega obrata.
• Zagotavljanje strokovne podpore za načrtovanje USP procesa in izbora najsodobnejše opreme pri postavljanju visokotehnološkega avtomatiziranega obrata za proizvodnjo bioloških učinkovin.
• Priprava uporabniških zahtev za USP opremo, definicija ključnih tehničnih in kakovostnih parametrov posamezne opreme in celotnih sistemov.
• Postavitev strategije testiranj opreme, zagonov in kvalifikacij USP opreme ter skrb, da so kvalifikacijske aktivnosti pravočasno in kvalitetno izvedene.
• Spodbujanje optimizacije USP procesov, vključitev znanja operativne odličnosti v načrtovanje USP procesov in obrata, inovacij, proaktivna skrb za skladnost.
• Zagotavljanje, da so vse dejavnosti v skladu s trenutnimi dobrimi praksami (cGxP), ter v skladu z integriteto podatkov.
• Sodelovanje pri strateških dejavnostih, projektih, odločitvah, zagotavljanje najsodobnejših proizvodnih in laboratorijskih procesov.
• Skrb za timsko delo, delitev znanja in izkušenj, uporabljanje široke baze znanja z različnih področij in aplikacija teh znanj na projektu.
• Izvajanje aktivnosti v skladu s sistemom kakovosti v Leku, ki je skladen s slovensko in evropsko zakonodajo, FDA, mednarodnim svetom za usklajevanje tehničnih zahtev glede zdravil, Konvencijo o farmacevtski inšpekciji in Sandozovimi standardi.

Vaš prispevek k delovnemu mestu:

• Univerzitetna izobrazba s področja biotehnologije, kemije, farmacije, farmacevtske tehnologije, inženirstva ali druge ustrezne naravoslovne oziroma tehnične smeri. Zaželen je magisterij.
• Obseg zahtevanih izkušenj je odvisen od ravni delovnega mesta. Pri kandidatih z manj izkušnjami pričakujemo osnovne praktične izkušnje na področju bioprocesov, podpore proizvodnim procesom in/ali kakovosti, pridobljene pri delu, strokovni praksi ali raziskovalnih projektih. Za senior pozicije je zahtevanih najmanj 5 let ustreznih delovnih izkušenj.
• Osnovno razumevanje upstream procesov (USP) ter načel dobre proizvodne prakse (GMP). Pri senior pozicijah pričakujemo poglobljeno poznavanje procesov, opreme in zahtev kakovosti ter sposobnost samostojnega strokovnega dela.
• Napredna raven znanja angleškega jezika. Znanje slovenskega jezika je zaželeno.
• Odgovoren in samoiniciativen pristop k delu ter sposobnost prevzemanja odgovornosti za svoje področje dela in dogovorjene naloge, spremljanja njihove izvedbe do zaključka ter pravočasnega opozarjanja na tveganja in predlaganja rešitev.
• Sposobnost sodelovanja z različnimi strokovnimi področji, izmenjave znanja in skupnega reševanja izzivov ob razumevanju vpliva lastnega dela na celoten proizvodni proces.

Kaj nudimo:

Lokacija dela: Ljubljana

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

Predvideni tedenski delovni čas: 40 ur

Plačni razpon (letna bruto plača):

Senior Process Expert: 45.120 – 67.680 EUR*

Process Expert I: 30.960 – 46.440 EUR*

Process Expert II: 28.880 – 43.320 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 2.450,00 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 (zgornja zneskovna omejitev je 3.224,18 EUR letno).
• Kolektivno življenjsko in nezgodno zavarovanje (kritje velja 24/7).
• Hibridno delovno okolje, ki omogoča fleksibilnost in možnost dela na daljavo. – če to velja za zadevno delovno mesto.

Ste pripravljeni na naslednji korak v karieri?
Prijavo z življenjepisom v angleškem ali slovenskem jeziku lahko oddate najpozneje do 1. december 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

___________________________________________________________________

At Lek, we are building the future of biopharmaceuticals. Our Ljubljana site is becoming one of the largest and most technologically advanced biopharmaceutical hubs for the development and manufacturing of biologic medicines, helping to improve access to modern therapies for patients around the world. As we continue to expand our capabilities, we are looking for talented professionals who want to contribute to a dynamic, international environment and play a role in shaping one of the fastest-growing sectors of the pharmaceutical industry.

To strengthen our team in manufacturing process technology, we are looking for several new colleagues, with employment expected to start in 2027.

We welcome applications from experienced professionals and candidates with less experience who already have foundational technical knowledge and practical experience in bioprocessing, pharmaceutical manufacturing or related fields and wish to further develop their expertise in biopharmaceuticals.

Your key responsibilities:

• Participation in the establishment of a state‑of‑the‑art upstream process (USP), including selection of suitable equipment, preparation of User Requirement Specifications (URS), collaboration with suppliers, and support during equipment and process testing, start‑up, and validation activities.
• Contributing to the development of technological documentation, definition of process parameters and recipes, and ensuring robust, compliant, and efficient control of the USP process through automated systems after the new facility is established.
• Providing technical support for the design of the USP process and selection of the most advanced equipment for a high‑technology automated facility for biological drug substance manufacturing.
• Preparing user requirement specifications for USP equipment and defining key technical and quality parameters for individual equipment and entire systems.
• Establishing the testing strategy for equipment, start‑ups, and qualifications of USP equipment, and ensuring qualification activities are completed on time and with high quality.
• Driving optimization of USP processes, integrating operational excellence principles into USP process and facility design, fostering innovation, and proactively ensuring compliance.
• Ensuring all activities are conducted in accordance with current good practices (cGxP) and data integrity principles.
• Participating in strategic activities, projects, and decision‑making processes to ensure state‑of‑the‑art manufacturing and laboratory operations.
• Fostering teamwork, knowledge‑sharing, and leveraging a broad knowledge base from different fields, and applying this expertise within the project.
• Performing activities in accordance with the Lek quality system, aligned with Slovenian and European legislation, FDA requirements, ICH guidelines, the Pharmaceutical Inspection Co‑operation Scheme (PIC/S), and Sandoz standards.

What you will bring to the role:

• A university degree in Biotechnology, Chemistry, Pharmacy, Pharmaceutical Technology, Engineering or another relevant scientific or technical discipline. A master's degree is desirable.
• The required level of experience depends on the role level. Candidates with less experience are expected to have basic practical experience in bioprocessing, manufacturing process support and/or quality, gained through employment, internships or research projects. Senior roles require at least 5 years of relevant professional experience.
• A basic understanding of upstream processes (USP) and Good Manufacturing Practice (GMP) principles. For senior roles, we expect in-depth knowledge of processes, equipment and quality requirements, as well as the ability to work independently in a technical capacity.
• Advanced proficiency in English. Knowledge of Slovenian is desirable.
• A responsible and proactive approach to work, with the ability to take ownership of your area of responsibility and agreed tasks, follow them through to completion, and flag risks and propose solutions in a timely manner.
• The ability to collaborate across different disciplines, share knowledge and solve challenges together, with an understanding of how your work affects the overall manufacturing process.

What we offer:

Job location: Ljubljana

Contract type: permanent contract with 6-month probation period

Expected weekly working hours: 40

Pay range (annual gross salary):

Senior Process Expert: EUR 45,120 – 67,680*

Process Expert I: EUR 30,960 – 46,440*

Process Expert II: EUR 28,880 – 43,320*

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 €2,450.00 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 – if applicable for position

Ready for your next career move?
You are kindly invited to submit your application in English or Slovene, including a CV, by 1 December 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