Vodja tehnoloških prenosov (m/ž/d) / Technical Transfer Lead (m/f/d)

Salary Range: 32.060,00 € - 59.540,00 € Job Description Summary #LI-Hybrid Location: Ljubljana, Slovenija Relocation Support: This role is based in Ljubljana, Slovenia. Novartis is unable to offer relocation support: please only apply if accessible. Pridružite se nam kot Vodja tehnoloških prenosov! Imeli boste odgovornost za tehnološke prenose na ravni proizvodne lokacije (na lokacijo ali z nje), vključno s povečevanjem velikosti serij in drugimi prilagoditvami procesov. Zadolženi boste tudi za vodenje tima, ki je odgovoren za prenose tehnologij na lokaciji ter se učinkovito povezuje s funkcijami, ki pri tem sodelujejo (npr. razvoj, oskrba, proizvodnja, kontrola kakovosti, ZVO, druge proizvodne lokacije), skladno z zakonodajo, internimi predpisi, dobrimi praksami in poslovnimi cilji. _____________ Join us as a Technical Transfer Lead! You will be responsible for technology transfers at the manufacturing site level (to and from the site), including scale-up activities and other process adaptations. You will also be responsible for leading the team in charge of technology transfers at the site and effectively liaising with the involved functions (e.g., development, supply, production, quality control, HSE, other production sites), in accordance with legislation, internal regulations, good practices, and business objectives. Job Description Vaše ključne odgovornosti: Pregled in posodabljanje ocene tveganj glede kakovosti pred prenosom in validacijo ter po potrebi prilagajanje strategije kontrole. Skrb za razpoložljivost vseh pomembnih tehničnih informacij in dokumentacije za validacijo. Opredelitev predvalidacijske in validacijske strategije, vključno s procesom, čiščenjem, pakiranjem ter spremljajočimi raziskavami (npr. čas stanja očiščene/neočiščene opreme). Koordinacija tehnične, registracijske in validacijske serije na lokaciji. Pregled validacijskih protokolov in poročil. Izvajanje lokalnega nadzora sprememb sistemov na lokaciji ter skrb za njihovo odobritev in zaključek. Vzpostavljanje načrta projektov za lokacijo, priprava znanstveno utemeljene tehnične strategije s projektno ekipo, priprava načrtov za ravnanje v izrednih razmerah, opredeljevanje ovir ter predlaganje rešitev. Ocenjevanje in načrtovanje potreb po virih na lokaciji ter pridobivanje soglasij vodstva za stroške projektov (npr. ekvivalenti polnega delovnega časa, stroški serij, investicije in zunanji stroški), strategije in časovni okvir. Sestavljanje in vodenje projektne ekipe na lokaciji, določanje prioritet za projekte in seje projektne ekipe, koordinacija aktivnosti ter skrb za skladnost s smernicami. Vaš doprinos k delovnem mestu: Univerzitetna diploma farmacevtske, kemijske ali druge ustrezne naravoslovne smeri. Zaželen magisterij iz omenjenih smeri. Zaželeno vsaj 5 let ustreznih izkušenj s področja farmacevtske proizvodnje. Aktivno znanje angleškega jezika. Poznavanje orodja Microsoft Office. Z izbranim kandidatom bomo sklenili delovno razmerje za nedoločen čas s poskusno dobo 6 mesecev. V Novartisu smo zavezani k soustvarjanju prihodnosti medicine ter priznavanju in nagrajevanju ljudi, ki to omogočajo. Pričakovani letni osnovni razpon plače za delovno mesto: 32.060,00 - 59.540,00 € 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 €). 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: 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? ________________________ Key Responsibilities: Review and update quality risk assessments prior to transfer and validation, and adjust control strategies as needed. Ensure the availability of all critical technical information and documentation for validation. Define pre-validation and validation strategies, including process, cleaning, packaging, and related studies (e.g., hold time for cleaned/uncleaned equipment). Coordinate technical, regulatory, and validation batches at the site. Review validation protocols and reports. Perform local oversight of system changes at the site and ensure their approval and closure. Establish project plans for the site, prepare scientifically justified technical strategies with the project team, develop contingency plans, identify obstacles, and propose solutions. Assess and plan resource needs at the site and obtain management approval for project costs (e.g., full-time equivalent resources, batch costs, investments, and external expenses), strategies, and timelines. Assemble and lead the site project team, set priorities for projects and project team meetings, coordinate activities, and ensure compliance with guidelines. What you will bring to the role: University degree in pharmacy, chemistry, or another relevant natural science. A master’s degree in the mentioned fields is preferred. At least 5 years of relevant experience in pharmaceutical manufacturing is desirable. Proficiency in English. Knowledge of Microsoft Office tools. We offer a permantent employment with 6 months of probation period. At Novartis, we’re committed to reimagining medicine together - and rewarding the people who make it happen. Expected Annual Base Salary Range for role: 32.060,00 - 59.540,00 € The 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. Pay equity is a fundamental principle of our employment policy and reflects our commitment to create a diverse, equitable and inclusive environment that treats all employees with dignity and respect, as outlined in our Code of Ethics. 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: Note: Benefits and compensation may vary by country and are subject to local legal requirements, including provisions of collective bargaining agreements where applicable. A full overview of your compensation package, including any relevant collective bargaining agreement details applicable to your role based on your employment location and Novartis employer entity, will be communicated separately to you during the application process. 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. Skills Desired Applied Statistics, Manufacturing Production, Manufacturing Technologies, Operational Excellence, Process Control, Quality Compliance, Regulatory Compliance, Technical Leadership, Technology Transfer