Job Description
Job Description Summary
Location: Menges, Slovenia #onsite
Role Purpose:
Vodilni raziskovalec v tehničnem razvoju procesov biofarmacevtskih učinkovin, oddelek Celične banke, bo odgovoren za strategijo in izvajanje procesov za področje GMP proizvodnje celičnih bank.
The Senior expert will be responsible for the strategy and execution of processes for GMP production of cell banks.
Job Description
Vaše glavne delovne odgovornosti:
Načrtovanje in vodenje proizvodnje celičnih bank v skladu z GxP standardi, pregledi in odobritve izpolnjenih proizvodnih poročil.
Zagotavljanje skladnosti z regulatornimi zahtevami (ICH, FDA, EMA)
Samostojno načrtovanje, koordinacija izvedbe (razporejanje dela med tehniki).
Priprava dokumentacije za proizvodnjo celičnih bank vključno s podporno dokumentacijo (npr. ocene tveganja).
Samostojno reševanje odstopov od dobre prizvodne prakse ter obvladovanje sprememb v GMP okolju.
Delovati kot ključni proizvodni ekspert pri inšpekcijah in presojah
Vodenje evalvacije, razvoja in implementacije novih proizvodnih 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 2 leti izkušenj iz področja, ali z magisterijem znanosti in najmanj 6 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 potreošnega materiala).
Poglobljeno razumevanja dela s celičnimi linijami.
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.
Ugodnosti in nagrajevanje:
Benefits and rewards:
Konkurenčen plačni paket, letni bonus, fleksibilen način dela z možnostjo prilagajanja urnika in delom od doma, pokojninska shema, možnost vključitve v kolektivno zdravstveno zavarovanje, shema nagrajevanja in priznanja dosežkov, razširjeni program promocije zdravja na področju fizičnega in duševnega dobrega počutja ter delovne obremenitve (Polni življenja), številne priložnosti za učenje in razvoj.
Preberite naš priročnik, da spoznate načine, s katerimi bomo spodbujali vaš osebni in profesionalni razvoj: https://www.novartis.com/careers/benefits-rewards
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
Key Responsibilities:
Plan and lead cell bank manufacturing in accordance with GxP standards; review and approve completed batch records.
Ensure compliance with regulatory requirements (ICH, FDA, EMA).
Independently plan and coordinate execution (allocate work among technicians).
Prepare documentation for cell bank manufacturing, 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 expert during inspections and audits.
Lead the evaluation, development and implementation of new manufacturing 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 2 years of relevant experience, or with an MSc and at least 6 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.
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 and Rewards:
Competitive salary, Annual bonus, Flexible working schedule, tailored to your needs, possibility to work from home, Pension scheme, possibility of joining collective health insurance scheme, Employee Recognition Scheme, Expanded program for the promotion of health in the field of physical and mental well-being and managing workload (Well-being), Unlimited learning and development opportunities.
https://www.novartis.com/careers/benefits-rewards
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
Why Novartis: Helping patients and their families takes more than innovative science. It takes a community of dedicated people like you. At Novartis, we value collaboration, support and inspiring each other to develop breakthrough therapies that change patients’ lives. Are you ready to create a brighter future with us?
https://www.novartis.com/about/strategy/people-and-culture
Skills Desired