Senior Expert Technical Transfers/Višji strokovni tehnični prenosi

Salary Range:

€46,550.00 - €86,450.00

 

Job Description Summary

Location: Menges, Slovenia #onsite

Role Purpose:
The Senior Expert Technical Transfers oversees clinical manufacturing site activities for drug substance and product process transfers, acting as the main contact throughout all transfer phases. They handle transfer tasks at the site level, including scale-ups and adaptations, lead the technical transfer team, and coordinate with relevant functions like Technical Development, Supply Chain, and Quality Control. They ensure processes fit at the receiving site through assessments of facilities, equipment, materials, and capabilities. They also manage internal and external stakeholders and contribute to project strategies while addressing complex issues within a multifunctional team.


Namen vloge:
Višji strokovni tehnološki transferji nadzorujejo dejavnosti kliničnih proizvodnih lokacij za prenos snovi zdravil in proizvodnih procesov ter delujejo kot glavni kontakt skozi vse faze prenosa. Izvajajo naloge prenosa na ravni lokacije, vključno z nadgradnjami in prilagoditvami, vodijo tehnično prenosno ekipo ter usklajujejo z relevantnimi funkcijami, kot so Tehnični razvoj, dobavna veriga in nadzor kakovosti. Zagotavljajo, da se procesi ujemajo na lokaciji prejemnika z ocenami objektov, opreme, materialov in zmogljivosti. Prav tako upravljajo notranje in zunanje deležnike ter prispevajo k projektnim strategijam, hkrati pa rešujejo kompleksna vprašanja znotraj večnamenske ekipe.

 

Job Description

Major Accountabilities:

• Upon receiving the documented Supply Point Decision, initiates technology transfer activities. Provides leadership and oversight for change control as required during the transfer process. Initiates and concludes transfer activities through a change control procedure.
• Proactively communicates the overall project strategy, key issues, and other critical topics promptly to the appropriate management level within technical line functions and the project teams.
• Ensures the nomination of the process transfer team at the receiving site and establishes appropriate team roles and responsibilities for activities on-site.
• Sets priorities for the transfer team and offers performance feedback for the team and its members, if requested by line functions.
• Contributes expert responses to health authority questions.
• Develops a scientifically sound technical transfer strategy and plans in alignment with the CMC team strategy, and coordinates between the transferring and receiving sites.
• Ensures comprehensive knowledge transfer from the transferring site to the receiving site.
• Ensures that planning, execution, and documentation adhere to best practices for technology transfer, regulatory guidelines, and quality standards.
• Monitors the progress of the technical transfer project.
• Collaborates with the sub-team to identify roadblocks, risks, and issues, and to develop solutions and mitigation plans.
• Outlines internal resources (FTEs) and external costs related to tech transfer activities in alignment with line function management and project teams.
• Drafts key transfer documents and source & registration materials.

Education (minimum/desirable):

• Minimum: Bachelor’s degree or equivalent
• Desirable: Advanced degree in a technical, scientific or relevant discipline (Master’s degree or equivalent) BS + 5-6 yrs. Industry experience/MS + 2-4 yrs. Industry experience/Ph.D. + 0-3 yrs. experience with Technical Expert studies

• Languages: Technical knowledge of English.

Requirements:

• Successfully demonstrated 3 years of directly related experience as expert or equivalent.
• Recognized expertise in a specific area.
• Thorough understanding of bussiness processes.
• Good knowledge of software and computer tools.
• Ability to work in and/or lead interdisciplinary teams and/or cross-cultural teams.
• Proven leadership and project management skills.
• Strong knowledge of relevant SOP, GLP, GMP and Novartis regulations and policies.
• Strong communication skills. Strong presentation skills and scientific/technical writing skills. Advanced coaching skills.
• May require up to 15% travel.

Desirable:

• Strong attention to detail with the ability to accurately follow instructions and procedures.
• Good organization and documentation skills, ensuring records are maintained according to company policies.
• Good presentation skills, basic coaching skills and good technical writing skills.
• Flexibility to adapt to changing priorities and ability to work independently or as part of a team. Willingness to work in a fast-paced and challenging environment to meet production goals and deadlines.
• Problem-solving mindset with a proactive approach to finding solutions.

Benefits & Rewards

 

At Novartis, we’re committed to reimagining medicine together - and rewarding the people who make it happen.

 

Expected Annual Base Salary Range for role: €46,550 to €86,450

 

The base salary offered is determined based on gender-neutral objectives, such as relevant skills, competencies and experience in accordance with the Novartis pay setting policy and upon joining Novartis will be reviewed periodically.

 

In addition to your base salary, you may be eligible for a performance-based bonus depending on certain performance parameters.

 

The rewards of being part of our team go far beyond base pay and incentives. We also offer a variety of competitive benefits in kind to help you thrive personally and professionally, such as insurance plans, retirement plans, wellbeing resources and global recognition programs. In addition, we provide flexible and hybrid working options, where possible, and minimum 14 weeks paid parental leave.

 

Glavne odgovornosti:

• Po prejemu dokumentirane odločitve o dobavni točki začne dejavnosti prenosa tehnologije. Zagotavlja vodstvo in nadzor nad nadzorom sprememb, kot je potrebno med postopkom prenosa. Začne in zaključi prenosne aktivnosti preko postopka nadzora sprememb.
• Proaktivno hitro sporoča celotno projektno strategijo, ključna vprašanja in druge ključne teme ustrezni ravni vodstva znotraj tehničnih linijskih funkcij in projektnih ekip.
• Zagotavlja nominacijo ekipe za prenos procesov na prejemni lokaciji ter določa ustrezne vloge in odgovornosti ekipe za dejavnosti na kraju samem.
• Določa prioritete za prestopno ekipo in ponuja povratne informacije o uspešnosti ekipe in njenih članov, če to zahtevajo linijske funkcije.
• Prispeva strokovne odgovore na vprašanja zdravstvenih organov.
• Razvija znanstveno utemeljeno tehnično strategijo prenosa in načrte v skladu s strategijo ekipe CMC ter koordinira med mesti prenosa in prejemanja.
• Zagotavlja celovit prenos znanja od lokacije prenosa do prejemne lokacije.
• Zagotavlja, da načrtovanje, izvedba in dokumentacija sledijo najboljšim praksam za prenos tehnologije, regulativnim smernicam in standardom kakovosti.
• Spremlja napredek tehničnega prenosnega projekta.
• Sodeluje s podskupino pri prepoznavanju ovir, tveganj in težav ter pri razvoju rešitev in načrtov za ublažitev.
• Opisuje notranje vire (FTE) in zunanje stroške, povezane z dejavnostmi prenosa tehnologije, v skladu z ekipami za upravljanje funkcij linije in projekte.
• Osnutke ključnih prenosnih dokumentov ter vire in registracijske materiale.

Izobrazba (minimalna/zaželena):

Minimum: diploma ali ekvivalent

• Zaželeno: Napredna stopnja v tehnični, znanstveni ali relevantni disciplini (magisterij ali ekvivalent) BS + 5-6 let. Izkušnje v industriji/MS + 2-4 leta izkušenj v industriji/Ph.D. + 0-3 leta izkušenj s študijem tehničnih strokovnjakov
• Jeziki: Tehnično znanje angleščine.

Zahteve:

• Uspešno sem dokazal 3 leta neposredno povezanih izkušenj kot strokovnjak ali ekvivalent.
• Priznano strokovno znanje na določenem področju.
• Temeljito razumevanje poslovnih procesov.
• Dobro poznavanje programske opreme in računalniških orodij.
• Sposobnost dela in/ali vodenja interdisciplinarnih ekip in/ali medkulturnih ekip.
• Dokazane vodstvene in projektne spretnosti.
• Močno poznavanje ustreznih predpisov in politik SOP, GLP, GMP in Novartis.
• Močne komunikacijske veščine. Močne predstavitvene veščine in znanstveno/tehnično pisanje. Napredne coaching veščine.
• Lahko zahteva do 15 % potovanja.

Zaželeno:

• Močna pozornost do detajlov in sposobnost natančnega sledenja navodilom in postopkom.
• Dobre organizacijske in dokumentacijske veščine, ki zagotavljajo, da se evidenca vodi v skladu s politikami podjetja.
• Dobre predstavitvene veščine, osnovne coaching veščine in tehnične pisne veščine.
• Prilagodljivost za prilagajanje spreminjajočim se prioritetam in sposobnost samostojnega dela ali kot del ekipe. Pripravljenost za delo v hitrem in zahtevnem okolju za doseganje proizvodnih ciljev in rokov.
• Miselnost reševanja problemov s proaktivnim pristopom k iskanju rešitev.

Koristi in nagrade

V Novartisu smo zavezani skupnemu preoblikovanju medicine – in nagrajevanju ljudi, ki jo uresničijo.

Pričakovani letni osnovni plačni razpon za delovno mesto: €46,550 do € 86,450

Osnovna plača je določena glede na spolno nevtralne cilje, kot so relevantne veščine, kompetence in izkušnje v skladu s politiko plač Novartisa, ob vstopu v Novartis pa se redno pregleduje.

Poleg osnovne plače ste morda upravičeni do bonusa na podlagi uspešnosti, odvisno od določenih parametrov uspešnosti.

Nagrade članstva v naši ekipi segajo daleč preko osnovne plače in spodbud. Ponujamo tudi različne konkurenčne ugodnosti, ki vam pomagajo uspevati osebno in poklicno, kot so zavarovalni načrti, pokojninski načrti, viri za dobrobit in globalni programi priznanja. Poleg tega ponujamo, kjer je mogoče, prilagodljive in hibridne možnosti dela ter najmanj 14 tednov plačanega starševskega dopusta.

 

Skills Desired