Vodja tehnoloških prenosov (m/ž/d) / Technical Transfer Lead (m/f/d) job opportunity at Novartis.

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Novartis Vodja tehnoloških prenosov (m/ž/d) / Technical Transfer Lead (m/f/d)
Experience: 4-years
Pattern: full-time
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loacation Mengeš, Slovenia
loacation Mengeš....Slovenia

Job Description Summary #LI-Hybrid Lokacija / Location: Mengeš Novartis išče izkušene strokovnjake za pridružitev svoji biofarmacevtski ekipi Proizvodnih znanosti in tehnologij na delovnem mestu vodje tehničnega prenosa, s poudarkom na bioloških zdravilih ali celični in genski terapiji. Vodja tehničnega prenosa bo deloval kot kontaktna točka (SPoC) na lokaciji, odgovorna za vodenje izvajanja projektov ter podporo izmenjavi znanja in optimizaciji procesov med različnimi funkcijami in lokacijami. K prijavi vabimo kandidate, ki jih vodita inovativnost in odličnost ter si želijo zahtevne, a hkrati nagrajujoče kariere. To delovno mesto je locirano v mestu Mengeš, v Sloveniji. Novartis za to vlogo ne nudi podpore pri selitvi, zato prosimo, da se prijavijo le kandidati, katerim je ta lokacija dosegljiva. _____________ Novartis is seeking experienced professionals to join its biopharmaceutical Manufacturing Science & Technology team as a Technical Transfer Lead, with a focus on Biologics or Cell & Gene Therapy. The Technical Transfer Lead will serve as the on-site single point of contact (SPoC), managing project execution and supporting knowledge exchange and process optimization across various functions and sites. Candidates who are driven by innovation and excellence and desire a challenging yet rewarding career are encouraged to consider this opportunity. This role is based in Menges, Slovenia. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.   Job Description Vaše ključne odgovornosti: Delovati kot kontaktna točka (SPoC) na lokaciji za tehnične prenose: voditi in usmerjati vse aktivnosti za dodeljene projekte na ravni lokacije (proces, tehnologija, analitika, kapacitete ipd.). Oblikovati in voditi lokalno projektno ekipo – določati prioritete za projekt, organizirati in voditi sestanke projektne ekipe, usklajevati projektne aktivnosti ter zagotavljati skladnost z Novartisovimi smernicami ter zahtevami HSE in ustreznimi GMP smernicami. Vzpostaviti projektni načrt na ravni lokacije, skupaj s projektno ekipo oblikovati znanstveno utemeljene tehnične strategije, razviti nadomestne (contingency) načrte, prepoznati ovire ter predlagati ustrezne rešitve. Oceniti in načrtovati potrebe po kadrovnskih virih na lokaciji ter pridobiti odobritev vodstva za stroške projekta, strategijo in časovne roke. Izvesti oceno tehnične izvedljivosti za odločanje o izbrani oskrbni točki za izdelek v tesnem sodelovanju z drugimi deležniki. Določiti obseg in zasnovo prenosa izdelka. Sprožiti lokalni postopek upravljanja sprememb (change control) v sistemu na lokaciji ter zagotoviti njegovo pravočasno odobritev in zaključek. Zagotoviti pravočasno razpoložljivost tehnične dokumentacije v skladu z Novartisovimi smernicami. Pripravljati dokumente za prenos proizvodnega procesa (Protokoli in poročila). Vzpostaviti lokalne postopke in predloge za tehnične prenose ter prispevati k izboljšavam procesov in optimizaciji prenosa izdelkov. Vaš doprinos k delovnem mestu: Vsaj 4 leta ustreznih izkušenj v farmacevtski proizvodnji, na področju vodenja tehničnih prenosov / proizvodne znanosti in tehnologije / tehničnega razvoja / kakovosti. Celovito znanje biotehnoloških procesov ter izkušnje z izvajanjem prenosov procesov. Univerzitetna izobrazba (magisterij ali doktorat) s področja biologije, biokemije, biotehnologije, biokemijskega inženirstva ali enakovredne izkušnje. Tekoče znanje slovenskega in angleškega jezika. Izkušnje z vodenjem projektov 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, možnost vključitve v kolektivno zdravstveno zavarovanje,  shema nagrajevanja in priznanja dosežkov, razširjeni program promocije zdravja na področju fizičnega in duševnega dobrega počutja ter delovne obremenitve (Polni življenja).), številne priložnosti za učenje in razvoj.  Preberite naš priročnik, da spoznate načine, s katerimi bomo spodbujali vaš osebni in profesionalni razvoj: https://www.novartis.com/careers/benefits-rewards    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? https://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: https://talentnetwork.novartis.com/network     ________________________ Key Responsibilities : Act as single point of contact (SPoC) on site for technical transfers: Lead and steer all activities for assigned projects on site level (process, technology, analytics, capacity, etc.). Form and lead site project team - set priorities for project and project team meetings, coordinate project team activities, ensure that Novartis guidelines as well as HSE and corresponding GMP guidelines are met. Establish site project plan, elaborate scientifically sound technical strategies with project team, develop contingency plans, identify hurdles, and propose solutions. Assess and plan site resource needs and get management approval for the overall project costs, strategy and timelines. Perform technical feasibility assessment for supply point decision in close collaboration with other stakeholders. Determine scope / design of technical batches for transfer. Initiate local change control in system on site and ensure approval and closure. Ensure timely availability of technical documentation according to Novartis guidelines. Write Manufacturing Process Transfer Documents (protocol, report). Establish local procedures & templates for technical transfers and contribute to process improvements and optimization for product transfers. Essential Requirements: 4 years of relevant experience in pharmaceutical manufacturing, tech transfer management / manufacturing science and technology / technical development / quality Comprehensive know-how in biotechnology processes with experience in executing process transfers University degree (MSc. or PhD) in Biology, Biochemistry, Biotechnology, Biochemical Engineering, or equivalent experience Fluent in Slovenian and English Project management experience 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.  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.    Skills Desired Continual Improvement Process, General Hse Knowledge  , Knowledge Of Gmp, Manufacturing Processes, Manufacturing Production, Manufacturing Technologies, Process Control, Root Cause Analysis (RCA), Technology Transfer

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