REQ-10015596
Jul 17, 2024
Slovenia
Summary
+ 1000! In TRD Biologics & CGT, more than 1,000 associates spread across 5 locations are fully committed to deliver on our evolving pipeline of transformative treatments. We develop Biologics & CGT drug substance and drug products from candidate selection up to launch and drive competitive advantage through agility, innovation, and scale to best serve our portfolio, partners and patients. We are looking for a Senior Expert Science & Technology in Downstream Process Development.
About the Role
Key responsibilities:
Independent planning, designing, organizing, performing, and documenting scientific experiments/testing in development and clinical manufacturing.
Preparing protocols, reports, laboratory procedures and SOPs, development manuals and similar technical documentation required for clinical trial application and/or marketing authorization dossier submission.
Recording, management and evaluation of raw data/analyses/results, forming of sound scientific conclusions and providing suitable follow-up activities.
Independent development/optimization of DSP processes (DQP/GMP environment), independent process transfers to manufacturing (GMP).
Independent implementation of new technologies, equipment.
Searching/utilizing the knowledge from scientific and technical literature, presenting at internal/external conferences and/or network meetings.
Leading/actively contributing to project functional teams at locally and globally.
Prompt communication of achievements, risks, issues in all areas and active contribution to root cause investigations and trouble shootings. Active knowledge transfer to junior associates and cross-functional partners
Identifying and resolving complex problems.
Management of advanced/complex DSP equipment, including purchase, maintenance and qualification activities
Ensuring compliance to company policies, regulatory requirements and HSE requirements. Supporting regulatory and Novartis internal audits.
Ensuring proactive compliance and continuous improvement.
Responsibility for any other tasks specified in annual objectives, KPIs, per instruction by operational manager or by a special assignment.
Role Requirements:
University degree (MSc) or PhD in chemical engineering, pharmacy, pharmaceutical technology, chemistry, or another relevant scientific field.
Minimum 5 years of experiences in the field of biologics/small molecules development/manufacturing.
Active knowledge of English language required (oral & written).
We are looking for responsible, objective-driven candidates who value collaboration, teamwork and are open to new challenges and expanding their knowledge and expertise.
We offer permanent contract with a probationary period of 6 months, work in a dynamic environment, collaboration with various teams, and knowledge and experience exchange within the global Novartis system. You are kindly invited to submit your application, including CV, by August 14, 2024.
Why Novartis?
Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
You’ll receive:
Competitive salary, Annual bonus, Flexible working schedule, 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, Unlimited learning and development opportunities.
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
Join our Novartis Network:
If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
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Znanstveni svetovalec
Vodi in upravlja vse projektne/mrežne aktivnosti ter uporablja strokovno znanstveno/tehnično znanje/poznavanje GMP in/ali strokovno znanje s področja kakovosti za reševanje zahtevnih problemov s področja raziskav in razvoja v okviru večfunkcijske projektne ekipe; usmerja člane ekipe in prispeva h globalnim strategijam in ciljem; upravlja operativne vidike v laboratorijih ali obratih v skladu z zadolžitvami; pripravlja strategije o znanosti in tehnologijah.
Vaše ključne odgovornosti:
Oblikuje, načrtuje, izvaja/nadzoruje in spremlja vse aktivnosti imenovanih ekip/projektov; obvladuje večje število aktivnosti; izpolnjuje potrebe kupcev.
Skrbi za zahtevnejšo opremo ter jo uporablja; vzdrževanje oidstructure in potrebne investicije.
Aktivno prispeva k napovedim proračuna in sredstev ter k pripravi nepovratnih sredstev; zagotavlja ozaveščenost o stroških pri vseh projektih za katere je odgovoren.
Tolmači rezultate, vrednoti podatke, dela ustrezne zaključke; nadzoruje znanstvene aktivnosti v zvezi s projekti; izvaja zahtevnejše naloge brez uveljavljenih postopkov. Pregleduje in potrjuje neobdelane podatke, ki so jih pripravili drugi; kritično vrednoti rezultate in kritično presoja zaključke drugih znanstvenikov.
Sestavlja vplivne in dolgoročne splošne postopke v zvezi s procesi ali razvojne smernice ter vzpodbuja njihovo izvajanje; sestavlja znanstvena poročila, namenjena za zunanje partnerje, ter podpira pripravo registracijske dokumentacije; deluje kot tehnični ekspert pri presojah, inšpekcijah in skrbnih pregledih poslovanja.
Obvešča o problemih v okviru svoje pristojnosti in jih rešuje; komunicira; oid prenos znanja in izkušenj ali postopkov na druge oddelke ali zunanje pogodbene izvajalce, vključno z reševanjem problemov in usposabljanjem na lokaciji; službene poti lahko obsegajo tudi do 15% delovnega časa.
Za enote za tehnični razvoj: Oblikuje in implementira optimizirane znanstvene aktivnosti ali procese; oid lokalne in globalne ekipe; oid razvoj, izbor in uvajanje novih tehnologij.
Za enote GMP: zagotavlja upoštevanje zahtev cGMP.
Za vloge, usmerjene v tehnologije: Daje znanstvene; aktivno pospešuje izmenjavo znanj. Razvija, usmerja in oid znanstvene sodelavce; na internem nivoju predstavlja znanstvene rezultate ter prispeva k objavam, prezentacijam in patem.
Za vloge, usmerjene v projekte: Vodi podekipe posameznih funkcij; lastno funkcijo zastopa v tehničnih ekipah ter opravlja vse projektne naloge in odgovornosti v zvezi s svojo panogo. Ocenjuje in usklajuje potrebe po virih in časovne roke za projekte.
Odgovornost za osebni in strokovni razvoj.
Vodi pobude za proaktivno zagotavljanje skladnosti in stalnih izboljšav.
Izvajanje in upoštevanje vseh navodil in zahtev za zagotavljanje varnega dela, varovanja okolja in premoženja.
Ostale naloge določene z letnim pogovorom o ciljih in s kazalniki uspešnosti.
Vaš doprinos k delovnem mestu:
5 let izkušenj na primerljivem delovnem mestu
Doktorat ustrezne naravoslovne smeri
Aktivno znanje angleškega jezika
Poznavanje orodja Microsoft Office
Zakaj Novartis? Naš namen je soustvarjati medicino za izboljšanje in podaljševanje življenja ljudi, naša vizija pa je postati najbolj cenjeno in zaupanja vredno farmacevtsko podjetje na svetu. Kako lahko to dosežemo? S pomočjo naših ljudi. Prav naši sodelavci nas vsak dan spodbujajo, da dosežemo svoje ambicije. Postanite del te misije in se nam pridružite! Več na spodnji povezavi: https://www.novartis.com/about/strategy/people-and-culture
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.
Pridružite se naši mreži Novartis: V kolikor se ne prepoznate v zgornjem opisu delovnega mesta, vas vabimo, da se vpišete na spodnji povezavi v Novartisovo bazo talentov saj lahko tako vašo vlogo upoštevamo za podobne pozicije v prihodnosti: https://talentnetwork.novartis.com/network
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
Development
Innovative Medicines
Slovenia
Mengeš
SI19 (FCRS = SI019) Novartis farmacevtska proizvodnja d.o.o.
Research & Development
Full time
Regular
No
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 [emailprotected] 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.
REQ-10015596
Senior Expert Science & Technology (f/m/d) Znanstveni svetovalec v tehničnem razvoju (ž/m/d)
DevelopmentSlovenia