Key Responsibilities: 

• Own the knowledge of specific pharmaceutical manufacturing process technologies at platform level – primary focus on gene and cell therapy manufacturing.
• Act as the platform SME / SPOC for key topics at the interface with global Engineering, Technical Development and other organizations. 
• Benchmarking new technologies and equipment relevant for platform. Participate in the definition and selection of pharmaceutical equipment, through providing input to User Requirements. Provide technical expertise to Engineering for design activities in CAPEX projects around technologies. 
• Assure that the necessary benchmark is done internally in Novartis, and externally in the scientific and academic environment, in order to stimulate and to extend the knowledge, increasing the know-how of the associates and expanding it to the rest of the organization.
• Author and implement GOPs for technology assigned. 
• Participate in due diligence team evaluations, where applicable, for in-license projects.
• Strive to harmonize and optimize technical processes across the platform.
• Support sites in trouble shooting / root cause investigation by providing second level of specialist expertise as SME and by harmonizing and optimising related technical processes across the units.
• Set standards to perform technical feasibility trials related to process improvement and implementation of new manufacturing technologies. 
• Maintain the work at a global level at inspection readiness level and provide the necessary support in any internal or external audit in addition to providing input to and review of regulatory documentation.

What you will bring to the role:

• MSc. in Biochemistry, Biotechnology, Molecular Biology, Pharmacy, Pharmaceutical Technology, Chemistry or equivalent scientific degree. Desirable PhD. or equivalent experience.
• Fluent in English.
• Knowledge of MS Office.
• Minimum 10 years of work relevant to the specialist area of expertise (i.e. biologics DS or aseptic DP process development & manufacturing, with mandatory experience from the ATMP area).
• Proven process understanding (GMP, ATMP Regulatory aspects, Product LCM).
• Complex project management experience (stakeholder management, cross-functional teams from multiple locations).

We offer permanent employment with 6 months of probation period.

In accordance with Austrian law, we are obliged to disclose the minimum salary as stated in the collective bargaining agreement. For this position the minimum salary is € €84,864.64/year (on a full-time basis). The actual salary will be significantly higher, as we strive to maintain a competitive position in the market and consider your previous experience, qualifications and individual competencies. Please note this will be applicable only in case a candidate is hired on an Austrian contract.

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: http://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 and Inclusion:

Novartis is committed to building an outstanding, inclusive work environment and diverse teams' 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: http://talentnetwork.novartis.com/network

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Vaše ključne odgovornosti:

• Imeti znanje o specifičnih tehnologijah proizvodnih procesov v farmacevtski industriji na ravni platforme – s primarnim poudarkom na proizvodnji genskih in celičnih terapij.
• Delovati kot strokovnjak za platformo / enotna kontaktna točka za ključne teme na stičišču z globalnim inženiringom, tehničnim razvojem in drugimi organizacijami.
• Primerjati nove tehnologije in opremo, ki so pomembne za platformo. Sodelovati pri definiciji in izbiri farmacevtske opreme, z zagotavljanjem vhodnih podatkov za uporabniške zahteve. Zagotavljati tehnično strokovno znanje za inženiring pri oblikovalskih dejavnostih v CAPEX projektih, povezanih s tehnologijami.
• Zagotoviti, da se potrebna primerjava opravi interno v Novartisu in eksterno v znanstvenem in akademskem okolju, da se spodbuja in širi znanje, povečuje strokovno znanje sodelavcev in širi na preostali del organizacije.
• Avtor in izvajalec GOP-ov za dodeljeno tehnologijo.
• Sodelovati v ocenjevalnih ekipah za skrbni pregled, kjer je to primerno, za projekte licenciranja.
• Prizadevati si za usklajevanje in optimizacijo tehničnih procesov po celotni platformi.
• Podpirati lokacije pri odpravljanju težav / preiskavi vzrokov z zagotavljanjem druge ravni strokovnega znanja kot strokovnjak in z usklajevanjem ter optimizacijo povezanih tehničnih procesov po enotah.
• Postaviti standarde za izvajanje tehničnih preskusov izvedljivosti, povezanih z izboljšanjem procesov in uvajanjem novih proizvodnih tehnologij.
• Ohraniti delo na globalni ravni na ravni pripravljenosti na inšpekcijo in zagotoviti potrebno podporo pri vseh notranjih ali zunanjih revizijah ter zagotavljati vhodne podatke in pregled regulativne dokumentacije.

Vaš doprinos k delovnem mestu:

• Magisterij iz biokemije, biotehnologije, molekularne biologije, farmacije, farmacevtske tehnologije, kemije ali enakovredne znanstvene izobrazbe. Zaželen doktorat ali enakovredne izkušnje.
• Tekoče znanje angleščine.
• Poznavanje MS Office.
• Najmanj 10 let delovnih izkušenj, povezanih s specialističnim področjem strokovnega znanja (tj. razvoj in proizvodnja bioloških DS ali aseptičnih DP procesov, z obveznimi izkušnjami iz področja ATMP).
• Dokazano razumevanje procesov (GMP, regulativni vidiki ATMP, LCM izdelkov).
• Izkušnje s kompleksnim vodenjem projektov (upravljanje deležnikov, medfunkcijske ekipe z več lokacij).

Z izbranim kandidatom bomo sklenili delovno razmerje za nedoločen čas s poskusno dobo 6 mesecev.

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: http://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, 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.

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: http://talentnetwork.novartis.com/network