摘要
Trenutno iščemo zainteresirane in usposobljene strokovnjake za ekipo za klinično proizvodnjo zdravilnih učinkovin na naši lokaciji TRD v Mengšu, Slovenija.
Kot Višji ekspert za oskrbo zdravil bo vaša vloga vključevala delo kot tehnolog v klinični proizvodnji zdravilnih učinkovin. Ključne odgovornosti vključujejo zagotavljanje tehnične podpore za vzpostavitev proizvodnih procesov, razvoj konceptov, kot je validacija čiščenja, pripravo dokumentacije, npr. glavni proizvodni zapisi, in podporo rutinskim proizvodnim dejavnostim.
Postanite del dinamične ekipe, ki si prizadeva za preoblikovanje medicine in prinašanje upanja tistim, ki ga najbolj potrebujejo. Pridružite se nam pri oblikovanju prihodnosti zdravstvenega varstva in ustvarjanju pomembne razlike v življenju bolnikov po vsem svetu. Veselimo se vašega prihoda v našo ekipo!
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We are thrilled to announce the establishing of new clinical manufacturing facility in Slovenia, dedicated to accelerating the creation of innovative medicines for patients around the globe. This cutting-edge facility, located at Biocampus Mengeš, offers unparalleled opportunities for collaboration, innovation, and impact.
We are currently looking to hire passionate and skilled specialists in the Drug Substance Clinical Manufacturing Team at our TRD site in Mengeš, Slovenia.
As Senior Expert Drug Supply, your role will involve working as a technologist within drug substance clinical production. Key responsibilities include providing technical support for establishing production processes, developing concepts such as cleaning validation, preparing documentation like master batch records, and supporting routine production activities.
Be part of a dynamic team that is reimagining medicine and delivering hope to those who need it most. Join us in shaping the future of healthcare and making a meaningful difference in the lives of patients worldwide. We look forward to welcoming you to our team!
About the Role
Vaše ključne odgovornosti:
- Razumevanje praks, konceptov in procesov na področju klinične proizvodnje zdravilnih učinkovin in sodelovanje pri vzpostavitvi in vzdrževanju proizvodnega objekta za klinični material zgodnjega tehničnega razvoja.
- Načrtovanje, razporejanje in koordiniranje serij, kvalifikacij, validacij in drugih dejavnosti ekipe; kot višji strokovnjak podpira dejavnosti prenosa tehnologije.
- Vodenje razvoja in uvajanje novih tehnologij na tem področju.
- Samostojno načrtovanje, izvajanje, nadziranje in spremljanje vseh dejavnosti dodeljenih ekip/projektov v določenih časovnih okvirih.
- Prispevanje k notranjim (npr. GGA) in zunanjim presojam (npr. JAZMP), sodelovanje z zdravstvenimi organi in delovanje kot tehnični strokovnjak pri revizijah.
- Grajenje in vzdrževanje mreže znotraj in zunaj organizacije za pridobivanje znanj in najboljših praks.
- Biti vzor kulture odgovornosti, raznolikosti in vključenosti, zaupanja, visoke učinkovitosti ter nenehnih izboljšav.
- Prevzemanje odgovornosti za osebni in strokovni razvoj.
Vaš doprinos k delovnem mestu:
- Vsaj diploma ali enakovredna izobrazba iz farmacije, biokemije, biotehnologije, kemije, mikrobiologije ali enakovrednega področja. Zaželena je magistrska diploma iz tehnične, znanstvene ali druge ustrezne discipline.
- Najmanj 3 leta sorodnih izkušenj kot strokovnjak na področju tehničnega razvoja zdravil.
- Tehnično znanje angleščine.
- Miselnost reševanja problemov s proaktivnim pristopom k iskanju rešitev.
- Dobre komunikacijske veščine. Sposobnost učinkovitega komuniciranja in sodelovanja z različnimi medfunkcijskimi ekipami.
Zaželene izkušnje:
- Znanje GMP in izkušnje z delom v reguliranem proizvodnem okolju.
- Dobro poznavanje instrumentacije ali opreme, ki je pomembna za proizvodnjo bioloških zdravilnih učinkovin, in dobro poznavanje biotehnoloških proizvodnih procesov.
Z izbranim kandidatom bomo sklenili delovno razmerje za nedoločen čas s poskusno dobo 6 mesecev. Prijavo oddajte z življenjepisom v slovenskem in angleškem jeziku.
Ugodnosti in nagrajevanje: Konkurenčen plačni paket, letni bonus, fleksibilen način dela z možnostjo prilagajanja urnika in delom od doma, pokojninska shema, shema nagrajevanja in priznanja dosežkov, razširjeni program promocije zdravja na področju telesnega, duševnega in fizičnega počutja (iniciativa Polni življenja), številne priložnosti za učenje in razvoj.
Preberite naš priročnik, da spoznate načine, s katerimi bomo spodbujali vaš osebni in profesionalni razvoj: http://www.novartis.com/careers/benefits-rewards
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? http://www.novartis.com/about/strategy/people-and-culture
Pridružite se Novartisu: Ni pravo delovno mesto za vas? Prijavite se v našo bazo talentov, da ostanete v kontaktu z nami in se seznanite z ustreznimi kariernimi priložnostmi takoj, ko se pojavijo: http://talentnetwork.novartis.com/network
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.
Dostop in prilagoditve: V Novartisu si prizadevamo k vključenosti oseb z invalidnostjo in zagotavljanju ustreznih prilagoditev delovnega okolja posameznikom z omejitvami. V kolikor zaradi bolezni ali invalidnosti potrebujete ustrezne prilagoditve v kateremkoli delu selekcijskega procesa oziroma potrebujete prilagoditve pri izvajanju osnovnih nalog na delovnem mestu, nam pišite na naslov diversity.inclusion_slo@novartis.com in navedite, kakšne prilagoditve potrebujete ter vaše kontaktne podatke. Prosimo, vključite tudi podatek o številki razpisa, na katerega se prijavljate.
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Key Responsibilities:
- Understands applied practice, concepts and processes of Drug substance clinical manufacturing field and engages in setting-up and maintaining the FiH facility.
- Plans, schedules and coordinates batches, qualification, validation and other team activities; supports tech transfer activities as a senior expert.
- Drives development and implementation of new technologies in the field.
- Independently designs, plans, performs, supervises and monitors all activities of assigned teams/ projects within timelines.
- Significantly contributes to internal (e.g. GGA) and external audits (e.g. JAZMP), interacts with health authorities and acts as technical expert in audits.
- Builds and sustains strong network in- and out-side the organization for knowledge gain, best practice, lessons learned, and synergies.
- Role models a culture of accountability, diversity and inclusion, trust, high performance as well as continuous improvement
- Takes Responsibility for personal and professional development.
Essential Requirements:
- At least Bachelor’s degree or equivalent in Pharmacy, Biochemistry, Biotechnology, Chemistry, Microbiology or equivalent. Master’s degree in technical, scientific or relevant discipline is desirable.
- Minimum 3 years of related experience as an expert in biologics drug product technical research and development.
- Technical knowledge of English.
- Problem-solving mindset with a proactive approach to finding solutions.
- Good communication skills. Ability to effectively communicate and collaborate with diverse cross-functional teams.
Desirable Requirements:
- Knowledge of GMP and experience working in a regulated manufacturing environment.
- Good knowledge of instrumentation or equipment relevant to biologic drug substance production and good knowledge of biotechnological manufacturing processes.
We offer permanent employment with 6 months of probation period. Submit your application with the CV in Slovenian and English language.
Benefits and Rewards: 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 (Well-being), Unlimited learning and development opportunities.
Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: http://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.
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 diversity.inclusion_slo@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
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? http://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: http://talentnetwork.novartis.com/network
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: http://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.
