Resumen
Kot Vodja tehnoloških prenosov - ekspert boste odgovorni za kompleksne tehnološke prenose na nivoju proizvodne lokacije (na lokacijo ali z nje) ali večih proizvodnih lokacij, vključno s povečevanjem velikosti serij ali drugimi prilagoditvami procesov ter podpora lansiranju novih izdelkov. Prav tako boste vodili time odgovorne za prenose tehnologij na lokaciji ali večih proizvodnih lokacijah in se učinkovito povezovali 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.
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We are seeking a Senior Technical Transfer Lead who will be responsible for complex technology transfer activities at site level (within, inbound and outbound) or multi-site launch transfers, including any scale-up or other process adaptations, supporting launch readiness. They will also lead technical transfer project team at site or multi-sites and liaise efficiently with involved functions (e.g. Technical Development, Supply Chain, Production Unit, Quality Control, HSE, other sites.), in accordance with the law, internal regulations, good practices and business objectives.
About the Role
Vaše ključne odgovornosti:
- Strokovno vodenje in znanstvena podpora tehnoloških prenosov novih inovativnih izdelkov iz Novartisovih razvojnih centrov in drugih proizvodnih lokacij znotraj in zunaj Novartisove proizvodne mreže v Proizvodnjo trdnih izdelkov v Ljubljani.
- Vodenje in organizacija izdelave razvojnih serij inovativnih izdelkov v sodelovanj z Novartisovim tehničnim razvojem in strokovna interpretacija rezultatov kakovostnih atributov izdelanih serij.
- Priprava in razvoj tehnoloških rešitev za uvedbo novih visokotehnoloških proizvodnih sposobnosti na lokaciji, ki so potrebne za proizvodnjo inovativnih zdravil.
- Sodelovanje pri izdelavi poslovnih načrtov za nove investicije na podlagi znanstveno utemeljenih tehničnih rešitev.
- Postavitev strategije izdelave serij potrebnih za prenos izdelka, vključno s proizvodnim procesom, čiščenjem, pakiranjem in spremljajočimi raziskavami. Koordiniranje izdelave tehničnih, registracijskih in validacijskih serij na lokaciji.
- Sodelovanje pri ocenah tveganja glede kakovosti in prilagajanje strategij kontrole.
- Sodelovanje pri izvajanju ocen o tehničnih možnostih proizvodnje novih izdelkov na lokaciji za odločitev o določitvi lokacije izdelave novega izdelka znotraj Novartisa.
- Povezovanje z globalnim funkcijami, lokacijo, ki izdelek prenaša in s funkcijami na lokaciji.
- Zagotavljanje prenosa znanja iz lokacije, ki izdelek prenaša v Proizvodnjo trdnih izdelkov.
- Vzpostavljanje lokalnih postopkov in predlogov za prenos tehnologij.
Vaš doprinos k delovnem mestu:
- Univerzitetna diploma farmacevtske ali kemijske smeri, farmacevtske tehnologije ali druge ustrezne naravoslovne smeri. Zaželen magisterij iz omenjenih smeri.
- Minimalno 8 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. Prijavo oddajte z življenjepisom v slovenskem in angleškem jeziku.
Kaj nudimo:
Konkurenčen plačni paket, letni bonus, fleksibilen način dela, z možnostjo prilagajanja urnika in delom od doma, zaposlitev v podjetju s certifikatom TOP Employer, 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:
- Professional leadership and scientific support for the technological transfer of new innovative products from Novartis development centers and other manufacturing locations within and outside the Novartis production network to the Solids Production in Ljubljana.
- Leading and organizing the production of development batches of innovative products in collaboration with Novartis technical development and providing expert interpretation of the quality attribute results of the manufactured batches.
- Preparation and development of technological solutions for the implementation of new high-tech manufacturing capabilities at the site, required for the production of innovative medicines.
- Contribution to the preparation of business plans for new investments based on scientifically justified technical solutions.
- Development of a strategy for producing the required transfer product batches, including the manufacturing process, cleaning, packaging, and associated studies. Coordinating the production of technical, registration, and validation batches at the site.
- Participating in quality risk assessments and adapting control strategies.
- Collaborating in performing assessments of the technical production possibilities for new products at the site, to decide on the location for manufacturing the new product within Novartis.
- Connecting with global functions, the transferring location, and the functions at the site.
- Ensuring the transfer of knowledge from the transferring location to the Solids Production.
- Establishing local procedures and proposals for technology transfers.
Essential Requirements:
- BSc. in Pharmacy, Pharmaceutical Technology, Chemistry or equivalent scientific degree. Desirable MSc. or equivalent experience.
- Minimum 8 years of relevant experience in pharmaceutical manufacturing.
- Functional knowledge of English.
- Knowledge of Microsoft Office.
We offer permanent employment with 6 months of probation period. Submit your application with the CV in Slovenian and English language.
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 (Wellbeing), employment at Top SI Employer, 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.
