Process Expert II - Cell Banking Analytical Support (d/f/m) / Tehnolog proizvodnih procesov II - Celične banke (d/ž/m)

Sandoz is leading company in production of biosimilars, committed to shaping the future for an affordable healthcare for patients. With our cutting-edge technology and unwavering dedication, we are revolutionizing the accessibility to life saving biologic medicines. Join us in our mission to make a lasting impact on patients’ lives while driving manufacturing efficiency and scientific excellence in field of biosimilars. We're looking for a Process Expert II – Cell Banking Analytical Support to join our cell banking team.

In this role, you’ll be the front-line expert ensuring that analytical methods for cell banking and cell bank testing are established and implemented. You will share your expertise with team members and collaborate across departments to contribute to a culture of continuous improvement and to ensure that activities are in line with internal procedures, regulatory standards and business objectives. Your Key Responsibilities: Your responsibilities include, but not limited to: Ensure that analytical methods for MCB, WCB and PPCB cell bank (CB) testing are established and available.

Planning and managing analytical activities including the interpretation, evaluation and documentation of results. Ensure GMP compliant activities like shipment and QC testing of cell banks at CROs and keep control about good manufacturing practices (cGMP) compliance IPC methods. Facilitate comparability studies according to internal standards and act as Subject Matter Expert (SME) for specific techniques, products or technical processes related to cell banking. Preparation of SOPs, working instructions, master records in compliance with GMP requirements. Contribution to equipment qualification and validation of methods with deadlines and current regulations.

Provide risk / gap assessments, determine effectiveness of related corrective actions and collaborate with MS&T Experts regarding the definition of URS and execution of qualification and validation. Ensure overall inspection and internal audits readiness of the unit while providing operational support to teams during technology transfers. Knowledge transfer and mentoring of associates. What You Will Bring To The Role: University degree in pharmacy, chemistry, biotechnology, biology, microbiology, or another natural science field. Desirable MSc. or equivalent experience. Minimum 3 years of shop floor cell banking GMP experience. Proven process understanding of GMP and pharma industry regulations.

Fluent in English, local language skills are desirable but not mandatory. Knowledge of Microsoft Office. You’ll Receive: Employment at the most reputable employer in Slovenia offers Competitive salary, Annual bonus, Flexible working schedule, tailored to your needs, possibility to work from home, Pension scheme, Employee Recognition Scheme, expanded program for the promotion of health in the field of physical, mental and social well-being (Energized for Life), Unlimited learning and development opportunities. Possible job locations: Slovenia (Lendava)We offer permanent contract with 6-month of probation period.

You are kindly invited to submit your application in English language, including CV, by 1. 8. 2025. Why Sandoz?Generic and Biosimilar medicines are the backbone of the global medicines industry. In delivering over 900 million treatments with Sandoz medicines to patients around the world, 20,000 people of more than 100 nationalities are involved. While we are proud of this achievement, we have an ambition to do more!#Sandoz______________________________________________________________________Sandoz je vodilno podjetje na področju proizvodnje bioloških podobnih zdravil (biosimilarjev), zavezano oblikovanju prihodnosti dostopnega zdravstva za paciente. Z uporabo najsodobnejše tehnologije in neomajne predanosti spreminjamo dostopnost do življenjsko pomembnih bioloških zdravil.

Pridružite se naši misiji in pomagajte ustvarjati trajen vpliv na življenja pacientov, hkrati pa spodbujajte učinkovitost proizvodnje in znanstveno odličnost na področju biosimilarjev. Iščemo Tehnologa proizvodnih procesov za Celične banke, ki se bo pridružil naši ekipi strokovnjakov za celične banke. V tej vlogi boste ključni strokovnjak, ki bo skrbel za vzpostavitev in izvajanje analitskih metod za celično bankiranje in testiranje celičnih bank.

Svoje strokovno znanje boste delili s člani ekipe in sodelovali z drugimi oddelki, da bi prispevali h kulturi nenehnih izboljšav ter zagotovili, da so aktivnosti skladne z internimi postopki, regulativnimi standardi in poslovnimi cilji. Vaše Ključne Odgovornosti: Zagotoviti, da so analitske metode za testiranje MCB, WCB in PPCB celičnih bank vzpostavljene in na voljo. Načrtovati in voditi analitske aktivnosti, vključno z interpretacijo, vrednotenjem in dokumentiranjem rezultatov. Zagotoviti skladnost z GMP pri pošiljanju in QC testiranju celičnih bank pri zunanjih izvajalcih (CRO) ter nadzorovati skladnost IPC metod s cGMP.

Izvajati primerjalne študije v skladu z internimi standardi ter delovati kot strokovnjak (SME) za specifične tehnike, izdelke ali tehnične procese, povezane s celičnim bankiranjem. Pripravljati SOP-je, delovna navodila in glavne zapise v skladu z GMP zahtevami. Prispevati h kvalifikaciji opreme in validaciji metod v skladu z roki in veljavnimi predpisi. Izvajati ocene tveganj in neskladnosti, določiti učinkovitost korektivnih ukrepov ter sodelovati z MS&T strokovnjaki pri definiranju URS in izvajanju kvalifikacij in validacij. Zagotoviti pripravljenost na inšpekcije in notranje presoje ter nuditi operativno podporo ekipam med prenosi tehnologij. Prenos znanja in mentorstvo sodelavcem.

What You Will Bring To The Role: Univerzitetna izobrazba iz farmacije, kemije, biotehnologije, biologije, mikrobiologije ali druge naravoslovne smeri. Zaželen magisterij ali enakovredne izkušnje. Najmanj 3 leta izkušenj z GMP na področju celičnih bank. Dokazano razumevanje procesov GMP in regulative v farmacevtski industriji. Tekoče znanje angleščine; znanje lokalnega jezika je zaželeno, ni pa obvezno. Znanje uporabe Microsoft Office orodij. You’ll Receive:

Zaposlitev pri najuglednejšem delodajalcu v Sloveniji vam prinaša konkurenčen plačni paket, letni bonus, fleksibilen način dela z možnostjo prilagajanja urnika in delom od doma, pokojninsko shemo, shemo nagrajevanja in priznanja dosežkov, razširjeni program promocije zdravja na področju telesnega, duševnega in družbenega počutja (Polni življenja) ter dogodke, neomejene priložnosti za učenje in razvoj. Možne lokacije dela: Slovenija (Lendava)Z izbranim kandidatom bomo sklenili delovno razmerje za nedoločen čas s poskusno dobo 6 mesecev.

Prijave z življenjepisom v angleškem in slovenskem jeziku lahko oddate najkasneje do 01. 08. 2025 preko spletne povezave. Zakaj Sandoz in Lek?Generična in podobna biološka zdravila so hrbtenica svetovne industrije zdravil. Pri zagotavljanju več kot 900 milijonov terapij s Sandozevimi zdravili bolnikom po vsem svetu, sodeluje 20. 000 ljudi več kot 100 narodnosti. Na ta dosežek smo ponosni, a si želimo še več!#Sandoz