摘要
Kot član naše globalne ekipe strokovnjakov za mikrobiologijo boste imeli priložnost podpirati raznolik portfelj projektov znotraj tehničnih raziskav in razvoja, od klasičnih kemijskih molekul do biotehnoloških izdelkov in do novih modalitet, kot so oligonukleotidi in izdelki za radioligandno terapijo. Podpirali boste različne projektne ekipe s poudarkom na mikrobiološkem testiranju ter v sodelovanju s proizvodnjo zdravilnih učinkovin z nizko mikrobiološko obremenitvijo ter proizvodnjo sterilnih končnih izdelkov.
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We are looking for a Microbiology Expert Bioburden & Sterility testing, for a Senior Expert Science & Technology position in the team of Analytical Operations SI, TRD Mengeš.
As a member of our global Microbiology Expert Team, you will have the opportunity to support a diverse project portfolio within Technical R&D, from classical chemical molecules to biotech products and up to the new modality products such as oligonucleotides and radioligand therapy products. You will support the different project teams with a strong focus on microbiology testing as well on manufacturing low bioburden drug substances and sterile drug products.
About the Role
Vaše ključne odgovornosti:
- Delovali boste kot strokovnjak na področju analitskega testiranja (nizko) mikrobiološke obremenjenosti vzorcev in sterilnosti, podpirali projektne ekipe, npr. pri pregledu analitskih surovih podatkov in pri pregledu ustreznosti metod za testiranje. Podpirali boste proizvodnjo z nizko mikrobiološko obremenitvijo in sterilno proizvodnjo pri vprašanjih povezanih z mikrobiološkim testiranjem.
- Ustvarjali in delili boste najboljše prakse, v projektno ekipo in v širšo organizacijo boste prinašali močna znanstvena in tehnična znanja.
- Interno/eksterno boste predstavljali znanstvene/tehnične rezultate, prispevali boste k publikacijam in predstavitvam.
- Kot avtor ali pregledovalec boste prispevali k oblikovanju standardnih operativnih postopkov (SOP), delovnih postopkov, obrazcev, analitskih metod ali analitskih specifikacij.
- Vodili ali prispevali boste pri raziskavah dobljenih rezultatov izven specifikacij (OOS/OOE/OOT), pri kreiranju korektivnih in preventivnih ukrepov ter obvladovanju sprememb. Prispevali boste k oceni tveganj pri projektu. Pripravljali boste predloge za zmanjševanje rizikov pri naslavljanju tveganj za projekt in paciente, ki so povezani z mikrobiologijo.
- Proaktivno in pravočasno boste naslavljali ključna vprašanja in druge kritične teme z vodjo analitike na projektu in/ali, če je potrebno, z vodstvom in/ali z vsemi drugimi relevantnimi člani projektne ekipe.
- Podpirali boste notranje in zunanje presoje. Na dodeljenem področju boste zagotavljali in stremeli k temu, da na presojah ne bo kritičnih ugotovitev. Odgovarjali boste na zahteve zdravstvenih organov.
- Z zunanjimi in notranjimi testnimi laboratoriji boste gradili močno sodelovanje in standarde, s posebnim poudarkom na kakovosti analitike in integriteti podatkov.
- Upoštevali boste industrijske in farmakopejske standarde ter notranje postopke in smernice Novartisa.
Vaš doprinos k delovnem mestu:
- Doktorat, diploma ali magisterij iz mikrobiologije / biotehnologije (ali sorodne znanosti).
- Delovne izkušnje s testiranjem sterilnosti in mijrobiološke obremenjenosti v farmacevtski industriji / GMP.
- Tekoče znanje angleščine (ustno in pisno).
- Znanje o načelih kakovosti, kot so poznavanje GMP in pričakovanj glede kakovosti.
- Dobre komunikacijske veščine, vključno s predstavitvenimi veščinami ter veščinami znanstveno/tehničnega pisanja.
Zaželene izkušnje:
- Izkušnje na področju zagotavljanja sterilnosti, kot so strategija nadzora kontaminacij, simulacija aseptičnega procesa in validacija čistih prostorov.
- Izkušnje s testiranjem bakterijskih endotoksinov.
- Znanje slovenskega jezika.
Iščemo odgovorne, ciljno usmerjene kandidate, ki cenijo sodelovanje in timsko delo ter so odprti za nove izzive in širjenje svojega znanja in strokovnosti.
Z izbranim kandidatom bomo sklenili delovno razmerje za nedoločen čas s poskusno dobo 6 mesecev.
Vljudno vas vabimo, da svojo prijavo v angleškem jeziku, vključno z življenjepisom, pošljete do 9. junija 2025.
Kaj nudimo:
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.
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.
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Key Responsibilities:
- Act as subject matter expert in Bioburden and Sterility testing and support the project teams with e.g. the review of analytical raw data and method suitability test documents. Support the low bioburden and sterile manufacturing unit in Bioburden and Sterility testing related questions.
- Build-up and share best practices, bring strong scientific and technical expertise within the project teams and across the organization.
- Present scientific/technical results internally / externally and contribute to publications and presentations.
- Contribute as author or reviewer to the definition of standard operating procedures (SOPs), working procedures, forms, analytical methods or analytical specifications.
- Lead or contribute to “out of specification” investigations (OOS/OOE/OOT), corrective and preventative actions, and change controls. Contribute to project risk assessments. Provide mitigations to resolve microbiology related risks to projects and patients.
- Proactively communicate key issues and any other critical topics in a timely manner to the Analytical Project Leader and/or if appropriate to the management level and/or to any other relevant project team member(s).
- Support internal and external audits, ensure no critical findings within the assigned scope and support health authority request responses.
- Build strong collaboration and standards with external and internal testing laboratories, with special attention to analytical quality and data integrity.
- Respect industry and pharmacopoeia standards, as well as internal procedures and Novartis guidelines.
Essential Requirements:
- PhD, diploma, bachelor or master’s in microbiology / biotechnology (or related science).
- Working experience in Sterility- and Bioburden testing within pharmaceutical industry / GMP.
- Fluent in English (oral and written).
- Proficiency in quality principles such as GMP and quality expectations.
- Good communication skills including presentation and scientific/technical writing.
Desirable Requirements:
- Experience in Sterility assurance topics such as contamination control strategy, aseptic process simulation and clean room validation.
- Experience in Bacterial endotoxin testing.
- Slovenian language skills.
We are looking for responsible, objective-driven candidates who value collaboration and teamwork and are open to new challenges and expanding their knowledge and expertise.
We offer permanent contract, with 6 months of probation period for development projects, work in a dynamic environment, knowledge and experience sharing within the global Novartis system.
You are kindly invited to submit your application in English language, including CV by 9th of June 2025.
You’ll receive:
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.
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 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
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
