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Senior Expert, Technical Development (m/f/d) Vodilni raziskovalec v tehničnem razvoju (m/ž/d)
Mengeš
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Summary
In Biologics DS Development Mengeš, Cell Banking, we are looking for a colleague for the position:
Senior Expert Science&Technology (m/f)
The Senior expert will be responsible for the strategy and execution of processes for GMP production and testing of cell banks.
V razvoju bioloških zdravil Mengeš, Celične banke iščemo sodelavca za delovno mesto:
Vodilni raziskovalec v tehničnem razvoju (m/ž)
Vodilni raziskovalec v tehničnem razvoju procesov biofarmacevtskih učinkovin, oddelek Celične banke, bo odgovoren za strategijo in izvajanje procesov za področje GMP proizvodnje in testiranja celičnih bank.
About The Role
Key Responsibilities
:
- Plan and lead cell bank manufacturing and testing in accordance with GxP standards; review and approve completed batch records and analytical reports.
- Ensure compliance with regulatory requirements (ICH, FDA, EMA).
- Independently plan and coordinate execution (allocate work among technicians and analytics).
- Prepare documentation for cell bank manufacturing and testing, including supporting documentation (e.g., risk assessments).
- Independently manage deviations from Good Manufacturing Practice and manage change control in the GMP environment.
- Act as a key manufacturing and testing expert during inspections and audits.
- Lead the evaluation, development and implementation of new manufacturing and testing approaches and share knowledge at a global level.
- Train and mentor colleagues.
- Actively drive knowledge transfer and present scientific findings within the organization and contribute to optimizing work processes.
- Support cell bank transfers.
- Coordinate activities carried out by external partners.
- High level of integrity and proactive collaboration within local and global teams.
We Expect
- An expert in pharmaceutical technology, biotechnology, biochemistry, chemical engineering or another relevant natural science field, with a PhD and at least 3 years of relevant experience, or with an MSc and at least 5 years of relevant experience.
- Knowledge of general GxP standards and regulatory requirements in manufacturing in a low-bioburden environment (including understanding of cleanroom concepts, EM, raw materials and consumables).
- In-depth understanding of work with cell lines and molecular analytical methods.
- Ability to work in and lead cross-functional teams.
- Excellent collaboration and communication skills (ability to work effectively with others to achieve common goals through communication, teamwork and problem solving).
- Proactivity and an aptitude for working with external partners.
- Active knowledge of English language.
We are looking for responsible, objective-driven candidates who value collaboration, teamwork and are open to new challenges and expanding their knowledge and expertise.
We offer
permanent contract with 6 months of probation period
, work in a dynamic environment, collaboration with different teams, knowledge and experience sharing within the global Novartis system. You are kindly encouraged to submit your application in English and Slovenian language.
Benefits & Rewards
At Novartis, we’re committed to reimagining medicine together - and rewarding the people who make it happen.
Expected Annual Base Salary Range for role: Add € 46,550 to € 86,450
The base salary offered is determined based on gender-neutral objectives, such as relevant skills, competencies and experience in accordance with the Novartis pay setting policy and upon joining Novartis will be reviewed periodically. In addition to your base salary, you may be eligible for a performance-based bonus depending on certain performance parameters. The rewards of being part of our team go far beyond base pay and incentives. We also offer a variety of competitive benefits in kind to help you thrive personally and professionally, such as insurance plans, retirement plans, wellbeing resources and global recognition programs. In addition, we provide flexible and hybrid working options, where possible, and minimum 14 weeks paid parental leave.
In addition to your base salary, you will be eligible for benefits listed below:
- Annual bonus for all employees: 12% of annual base salary.
- Holiday allowance: In 2025 it amounted to €2,496 (net). For 2026 it amounts to €2,678.28 (net).
- Yearly performance-based bonus: In 2025 it amounted to €2,538.64 (gross), including the winter allowance.
- Voluntary supplementary pension insurance: Novartis in Slovenia provides voluntary supplementary pension insurance (5.844% of gross salary, capped annually at €3,054.65).
- Additional accident insurance: During employment at Novartis, the employee is insured 24/7 in the event of death or disability resulting from an accident.
- Specialist insurance: Group health insurance providing faster access to specialist healthcare services at Triglav Health Insurance Company d.d. for you and your family members.
- Care Connect: A program offering confidential, personalized support for mental health and well-being through therapy, counselling, tools, and more.
- Other benefits in accordance with legislation and collective agreements: Transportation, meal allowance, and other supplements.
Read our brochure to learn more about our global total rewards offering: https://www.novartis.com/sites/novartis\_com/files/novartis\-life\-handbook.pdf
Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
Vaše Glavne Delovne Odgovornosti
- Načrtovanje in vodenje proizvodnje, testiranja in sproščanja celičnih bank v skladu z GxP standardi, pregledi in odobritve izpolnjenih proizvodnih ali analitskih poročil.
- Zagotavljanje skladnosti z regulatornimi zahtevami (ICH, FDA, EMA).
- Samostojno načrtovanje, koordinacija izvedbe (razporejanje dela med tehniki in analitiki).
- Priprava dokumentacije za proizvodnjo, testiranje in sproščanje celičnih bank vključno s podporno dokumentacijo (npr. ocene tveganja).
- Samostojno reševanje odstopov od dobre proizvodne prakse ter obvladovanje sprememb v GMP okolju.
- Delovati kot ključni proizvodni in analitski ekspert pri inšpekcijah in presojah.
- Vodenje evalvacije, razvoja in implementacije novih proizvodnih in analitskih pristopov ter izmenjava znanj na globalni ravni.
- Izobraževanje in mentoriranje sodelavcev.
- Aktivno prenašanje znanja in predstavitev znanstvenih ugotovitev znotraj organizacije ter sodelovanje pri optimizaciji delovnih procesov.
- Sodelovanje pri prenosih celičnih bank.
- Koordiniranje aktivnosti, ki jih izvajajo zunanji partnerji.
- Visoka raven integritete in proaktivno sodelovanje znotraj lokalnih in globalnih timov.
Od Vas Pričakujemo
- Ekspert farmacevtske tehnologije, biotehnologije, biokemije, kemijskega inženirstva ali druge ustrezne naravoslovne smeri z doktoratom in najmanj 3 leta izkušenj iz področja, ali z magisterijem znanosti in najmanj 5 let izkušenj s področja.
- Poznavanje splošnih GxP standardov in regulatornih zahtev na področju proizvodnje v low bioburden okolju (vključeno z razumevanjem koncepta čistih prostorov, EM, surovin in potrošnega materiala).
- Poglobljeno razumevanja dela s celičnimi linijami in molekularnimi analitskimi metodami.
- Sposobnost vodenja in delovanja v več funkcijskih ekipah.
- Odlične sposobnosti sodelovanja in komunikacije (sposobnost učinkovitega sodelovanja z drugimi za doseganje skupnih ciljev s komunikacijo, timskim delom in reševanjem problemov).
- Proaktivnost, občutek za delo z zunanjimi partnerji.
- Aktivno znanje angleškega jezika.
Pričakujemo odgovorne, komunikativne osebe, usmerjene k timskemu delu in doseganju rezultatov, ki so pripravljene sprejemati nove izzive in stremijo k širitvi svojega znanja.
Ponujamo zaposlitev za
nedoločen čas, s 6 mesečno poskusno dobo
, delo v dinamičnem okolju, sodelovanje z različnimi timi ter izmenjavo znanj in izkušenj znotraj globalnega sistema Novartis. Prijavo z življenjepisom v angleškem in slovenskem jeziku.
Nagrajevanje
V Novartisu smo zavezani k soustvarjanju prihodnosti medicine ter priznavanju in nagrajevanju ljudi, ki to omogočajo.
Pričakovani letni osnovni razpon plače za delovno mesto:
- Slovenija: €
Osnovna plača se določa na podlagi vnaprej opredeljenih in transparentnih kriterijev, kot so relevantne veščine, kompetence in izkušnje, ne glede na spol, ter v skladu z Novartisovo politiko določanja plač. Po zaposlitvi v Novartisu se plača periodično pregleda v skladu z internimi akti in postopki.
Plačna enakost je temeljno načelo naše kadrovske politike in odraža našo zavezo k ustvarjanju raznolikega, pravičnega in vključujočega okolja, ki vse zaposlene obravnava dostojanstveno in spoštljivo, kot je opredeljeno v našem Kodeksu etike.
Poleg osnovne letne bruto plače so zaposleni upravičeni tudi do spodaj navedenih ugodnosti:
- Letni bonus, ki pripada vsakemu zaposlenemu: 12% letne plače.
- Regres za dopust: Leta 2025 je znašal 2.496 € (neto). Za leto 2026 znaša 2.678,28 € (neto).
- Nagrada za poslovno uspešnost: Leta 2025 je znašala 2.538,64 € (bruto), skupaj z zimskim regresom.
- Prostovoljno dodatno pokojninsko zavarovanje:Novartis v Sloveniji zagotavlja prostovoljno dodatno pokojninsko zavarovanje (5.844 % bruto izplačila, letno omejeno na €3,054.65
- Zavarovanje:
Dodatno nezgodno zavarovanje:
V času zaposlitve pri Novartisu je zaposleni 24/7 zavarovan za primer smrti ali invalidnosti, ki bi bila posledica nezgode.
Zavarovanje – Specialisti
: Kolektivno zdravstveno zavarovanje, ki omogoča hitrejši dostop do specialističnih zdravstvenih storitev pri Zavarovalnici Triglav d.d. za vas in vaše družinske člane.
- Care Connect: Program, ki ponuja zaupno, osebno podporo za vaše duševno zdravje in dobro počutje s pomočjo terapij, svetovanj, orodij in še mnogo več.
- Ostale ugodnosti v skladu z zakonom in kolektivno pogodbo: Prevoz, prehrana ter ostali dodatki.
Preberite brošuro in izvedite več o našem sistemu nagrajevanja: https://www.novartis.com/sites/novartis\_com/files/novartis\-life\-handbook.pdf
Opomba: Ugodnosti se lahko razlikujejo glede na državo ter so skladni z lokalno zakonodajo, vključno z določili kolektivnih pogodb. Celovit pregled vašega paketa prejemkov, vključno z morebitnimi relevantnimi določbami kolektivne pogodbe, ki veljajo za vašo delovno mesto glede na lokacijo zaposlitve in delodajalca Novartis, vam bo posredovan v okviru nadaljnjih korakov zaposlitvenega postopka.
Predani smo raznolikosti in vključenosti:
Novartis si prizadeva ustvariti izjemno, vključujoče delovno okolje in oblikovanje raznolikih timov, saj ti predstavljajo naše bolnike in skupnosti, ki jih oskrbujemo.
Zakaj Novartis:
Pomagati bolnikom in njihovim družinam zahteva več kot le inovativno znanost. Potrebna je skupnost zavzetih ljudi, kot ste vi. V Novartisu cenimo sodelovanje, podporo in navdihovanje drug drugega za razvoj prebojnih terapij, ki spreminjajo življenja pacientov. Ste pripravljeni ustvariti svetlejšo prihodnost skupaj z nami? https://www.novartis.com/about/strategy/people\-and\-culture
Why Novartis:
Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people\-and\-culture
Benefits and Rewards:
Learn about all the ways we’ll help you thrive personally and professionally.
Read our handbook (PDF 30 MB)
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