REQ-10014739
Jul 11, 2024
Slowenien

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 thru agility, innovation, and scale to best serve our portfolio, partners and patients. We are looking for an Expert Science & Technology in Upstream process development with the focus on pilot scale process expertise. If you are interested or in manufacturing of biologics on 1000 L scale and want to become part of engaged, curious team with can-do mentality and lots of opportunities ahead, come and join us!

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.
  • Developing and optimizaing of upstream processes, implementing of new technologies, searching/utilizating of knowledge from scientific and technical literature, presenting at internal/external conferences and network meetings, potentially contributing to scientific publications and patent applications.
  • Leading/contributing to project functional teams at locally and globally.
  • Prompt communication of achievements, risks, issues in all areas and contribution to root cause investigations and trouble shootings. Active knowledge transfer to junior associates and cross-functional partners
  • Identifying and resolving complex problems.
  • Contributing to process development and optimization.
  • Management of advanced/complex usptream 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.

Role Requirements:

  • University degree (MSc) in pharmacy, pharmaceutical technology, chemistry, engineering sciences, or another relevant scientific field.
  • 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 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 July 22, 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, 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, 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

Načrtuje, planira, dokumentira in tolmači znanstvene eksperimente ali GMP testiranja ali procese pilotnih obratov za pripravo in pravočasno dostavo zdravil, učinkovin, procesov ali postopkov; vzdržuje in kvalificira opremo/infrastrukturo ter v skladu z zadolžitvami upravlja operativne vidike v laboratoriju ali obratu.

Opis delovnega mesta:

  • Samostojno pod minimalnim nadzorom oblikuje, načrtuje, organizira, izvaja in dokumentira znanstvene eksperimente /testiranja GMP/aktivnosti na obratu; obvladuje več aktivnosti hkrati; razume in izpolnjuje potrebe kupcev.
  • Kot ekspert deluje kot skrbnik in uporabnik zahtevnejše opreme ; terminsko načrtuje in izvaja vzdrževanje in kvalifikacijo instrumev/opreme.
  • Zagotavlja dokumentiranje neobdelanih podatkov, vrednoti in tolmači rezultate, samostojno dela ustrezne zaključke in oblikuje naslednje eksperimente; nadzoruje znanstvene, povezane s projekti. Pregleduje in preverja neobdelane podatke drugih
  • Pod minimalnim nadzorom sestavlja protokole, znanstvena poročila, laboratorijske postopke ali splošne postopke; sestavlja znanstvene dokumente, namenjene zunanjim partnerjem ali pripravi registracijske dokumentacije.
  • Obvešča o problemih s področja, za katerega je odgovoren, jih obravnava in rešuje; učinkovito komunicira s kontaktnimi osebami v organizaciji; vodi prenos znanja in izkušenj na druge oddelke ali zunanje pogodbene izvajalce, tudi reševanje problemov in usposabljanje na lokaciji.
  • Za enote za tehnični razvoj: Razvija nove metode/procese ali optimizira obstoječe; prispeva k razvoju in uvajanju novih tehnologij.
  • Za enote GMP: Zagotavlja upoštevanje zahtev cGMP
  • Za vloge s poudarkom na tehnologijah: Daje znanstvene in tehnične smernice; išče informacije in dela poizvedbe v literaturi; aktivno vzpodbuja izmenjavo znanja. Usposablja in usmerja člane ekip, začasno zaposlene in zaposlene, ki se usposabljajo; izvaja interne predstavitve znanstvenih/ tehničnih rezultatov ter prispeva k objavam, prezentacijam in patem
  • Za vloge s poudarkom na projektih: Vodi/koordinira funkcijske podekipe; sodeluje v ekipah, specifičnih za posamezno funkcijo, ter pod minimalnim nadzorom izvaja projektne naloge in odgovornosti, ki so mu dodeljene.
  • 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.
  • Druge naloge po navodilu nadrejenega in naloge na podlagi posebnega imenovanja.

Minimalni pogoji:

  • Visokošolska izobrazba ustrezne naravoslovne smeri in 6 let izkušenj na primerljivem delovnem mestu, ali univerzitetna izobrazba / magisterij (MSc) ustrezne naravoslovne smeri in 3 leta izkušenj na primerljivem delovnem mestu ali doktorat ustrezne naravoslovne smeri brez izkušenj
  • Aktivno znanje angleškega jezika
  • Poznavanje orodja Microsoft Office

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
Slowenien
Mengeš
Research & Development
Full time
Regular
No
A female Novartis scientist wearing a white lab coat and glasses, smiles in front of laboratory equipment.
REQ-10014739

Expert Science & Technology (f/m/d) Raziskovalec ekspert (ž/m/d)

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