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