MS&T Ekspert – biološke učinkovine (d/ž/m) / Senior MS&T Expert (Biologics) (f/m/d)

Job Description Summary

Prihodnost je tu, oblikujmo jo skupaj. / The future is hours to shape.

Job Description

V Leku v Ljubljani gradimo enega največjih in tehnološko najbolj naprednih biofarmacevtskih centrov za razvoj in proizvodnjo bioloških učinkovin v Evropi. Center predstavlja ključen del globalne strategije Sandoza na področju podobnih bioloških zdravil.

V tej vlogi boste soustvarjali razvoj in uvajanje naprednih biofarmacevtskih tehnologij ter sodelovali pri prenosu inovativnih procesov v industrijsko okolje. Vaše delo bo neposredno vplivalo na razvoj zdravil, ki izboljšujejo kakovost življenja pacientov po svetu.

Kot ekspert v MS&T boste načrtovali, izvajali in interpretirali znanstvene ter tehnološke eksperimente. Sodelovali boste pri uvajanju novih tehnologij ter podpirali prenos procesov in znanja z razvojnega v proizvodno okolje, ob jasni in strukturirani komunikaciji rezultatov.

Vaše ključne odgovornosti:

• Zagotavljanje visokih standardov razvojne odličnosti ter delovanje kot nosilec ključnega strokovnega znanja na področju bioloških učinkovin 
• Ocenjevanje in uvajanje najsodobnejših tehnologij ter sodelovanje pri izboru procesne, PAT in laboratorijske opreme v okviru vzpostavitve naprednega biofarmacevtskega centra 
• Sodelovanje z dobavitelji opreme za enkratno uporabo (GMP consumables), pridobivanje tehnične dokumentacije ter izvajanje ocen tveganja (npr. L&E, endotoksini, fizikalno-kemijski parametri) 
• Evaluacija izdelkov za prenos na nove proizvodne linije ter prilagajanje opreme zahtevam posameznih procesov 
• Zagotavljanje skladnosti z GxP, internimi smernicami ter zahtevami s področij ZVO in ISEC 
• Izvajanje testiranj opreme (laboratorij, FAT, SAT) ter sodelovanje pri kvalifikacijah (IQ, OQ, PQ) in kalibracijah z ustrezno dokumentacijo 
• Priprava in vzdrževanje strokovne dokumentacije (SOP-ji, navodila, obrazci) ter zastopanje področja v okviru inšpekcijskih nadzorov 
• Sodelovanje z zunanjimi raziskovalnimi in razvojnimi inštitucijami ter prispevanje k identifikaciji in zaščiti inovativnih rešitev (patenti) 
• Sodelovanje pri prenosu tehnologij iz razvojnega v industrijsko okolje ter podpora validacijskim aktivnostim

Vaš prispevek k delovnemu mestu:

• Najmanj 7 let relevantnih delovnih izkušenj na področju proizvodnje, MS&T, tehničnega razvoja ali kakovosti v farmacevtski ali sorodni industriji 
• Zaključena univerzitetna izobrazba ali magisterij s področja kemije, biologije, farmacije ali druge ustrezne naravoslovne smeri 
• Tekoče znanje angleškega jezika ter aktivno znanje slovenskega jezika 
• Dobro poznavanje GxP okolja in regulativnih zahtev v farmacevtski industriji 
• Izkušnje z delom v mednarodnem okolju ali sodelovanjem v multidisciplinarnih projektnih ekipah
• Izkušnje z uvajanjem novih tehnologij, tehnološkim transferjem ali validacijo procesov (npr. IQ, OQ, PQ)

Kaj nudimo:

Lokacija dela: Ljubljana

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

Predvideni tedenski delovni čas: 40

*Plačni razpon: 40.600–75.400 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. – če to velja za zadevno delovno mesto

Ste pripravljeni na naslednji korak v karieri?
Prijavo z življenjepisom v angleškem in slovenskem jeziku lahko oddate najpozneje do 21. julij 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

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At Lek in Ljubljana, we are building one of the largest and most technologically advanced biopharmaceutical centres for the development and production of clinical and commercial batches of biologic drug substances in Europe. The centre represents a key part of Sandoz’s global strategy in the field of biosimilars.

In this role, you will co-create the development and implementation of advanced biopharmaceutical technologies and contribute to the transfer of innovative processes into the industrial environment. Your work will have a direct impact on the development of medicines that improve the quality of life for patients worldwide.

As an MS&T expert, you will design, execute, and interpret scientific and technological experiments. You will contribute to the implementation of new technologies and support the transfer of processes and knowledge from development to manufacturing, ensuring clear and structured communication of results.

Your key responsibilities:

• Ensuring high standards of development excellence and acting as a key subject matter expert in the field of biologics 
• Evaluating and implementing state-of-the-art technologies, and contributing to the selection of process, PAT, and laboratory equipment as part of the establishment of an advanced biopharmaceutical center 
• Collaborating with suppliers of single-use equipment (GMP consumables), obtaining technical documentation, and performing risk assessments (e.g., L&E, endotoxins, physico-chemical parameters) 
• Assessing products for transfer to new manufacturing lines and adapting equipment to meet process requirements 
• Ensuring compliance with GxP, internal procedures, and requirements related to HSE and ISEC 
• Performing equipment testing (laboratory, FAT, SAT) and supporting equipment qualification (IQ, OQ, PQ) and calibration activities with appropriate documentation 
• Preparing and maintaining technical documentation (SOPs, instructions, forms) and representing the function during health authority inspections 
• Collaborating with external research and development institutions and contributing to the identification and protection of innovative solutions (patents) 
• Supporting technology transfer from development to manufacturing scale and contributing to validation activities

What you will bring to the role:

• Minimum of 7 years of relevant experience in manufacturing, MS&T, technical development, or quality within the pharmaceutical or a related industry 
• Completed university degree or master’s degree in chemistry, biology, pharmacy, or another relevant scientific field 
• Fluent in English with working proficiency in Slovenian 
• Strong knowledge of GxP environment and regulatory requirements in the pharmaceutical industry 
• Experience working in an international environment or in cross-functional, multidisciplinary teams 
• Experience with the implementation of new technologies, technology transfer, or process validation (e.g., IQ, OQ, PQ) 

What we offer:

Job location: Ljubljana

Contract type: permanent contract with 6-month probation period

Expected weekly working hours: 40

*Pay range: €40,600 – €75,400 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 – if applicable for position

Ready for your next career move?
You are kindly invited to submit your application in English and Slovene, including a CV, by July 21st 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

Applied Statistics, Applied Statistics, Assembly Language, Back-End Development, Biotechnology, Chemical Engineering, Chemistry, Design Development, Electronic Components, General Hse Knowledge  , Incentive Program, Including Gdp, Knowledge Of Capa, Knowledge Of Gmp, Leadership, Manufacturing Process, Manufacturing Production, Manufacturing Technologies, Npd (New Product Development), Process and Cleaning Validation, Process Control, R&D (Research And Development), Root Cause Analysis (RCA), Software Development, Software Engineering {+ 1 more}

Global leader in generic and biosimilar medicines, operating as an independent company spun off from Novartis. Based in Basel.

sandoz.com