Senior Expert, Technical Development (m/f/d) Vodilni raziskovalec v tehničnem razvoju (m/ž/d)

Salary Range: €46,550.00 - €86,450.00 Job Description Summary In Biologics DS Development Mengeš, Cell Banking, we are looking for a colleague for the position: Senior Expert Science&Technology (m/f) The Senior expert will be responsible for the strategy and execution of processes for GMP production and testing of cell banks. V razvoju bioloških zdravil Mengeš, Celične banke iščemo sodelavca za delovno mesto: Vodilni raziskovalec v tehničnem razvoju (m/ž) Vodilni raziskovalec v tehničnem razvoju procesov biofarmacevtskih učinkovin, oddelek Celične banke, bo odgovoren za strategijo in izvajanje procesov za področje GMP proizvodnje in testiranja celičnih bank. Job Description Key Responsibilities : Plan and lead cell bank manufacturing and testing in accordance with GxP standards; review and approve completed batch records and analytical reports. Ensure compliance with regulatory requirements (ICH, FDA, EMA). Independently plan and coordinate execution (allocate work among technicians and analytics). Prepare documentation for cell bank manufacturing and testing, including supporting documentation (e.g., risk assessments). Independently manage deviations from Good Manufacturing Practice and manage change control in the GMP environment. Act as a key manufacturing and testing expert during inspections and audits. Lead the evaluation, development and implementation of new manufacturing and testing approaches and share knowledge at a global level. Train and mentor colleagues. Actively drive knowledge transfer and present scientific findings within the organization and contribute to optimizing work processes. Support cell bank transfers. Coordinate activities carried out by external partners. High level of integrity and proactive collaboration within local and global teams. We expect: An expert in pharmaceutical technology, biotechnology, biochemistry, chemical engineering or another relevant natural science field, with a PhD and at least 3 years of relevant experience, or with an MSc and at least 5 years of relevant experience. Knowledge of general GxP standards and regulatory requirements in manufacturing in a low-bioburden environment (including understanding of cleanroom concepts, EM, raw materials and consumables). In-depth understanding of work with cell lines and molecular analytical methods. Ability to work in and lead cross-functional teams. Excellent collaboration and communication skills (ability to work effectively with others to achieve common goals through communication, teamwork and problem solving). Proactivity and an aptitude for working with external partners. Active knowledge of English language. 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 6 months of probation period , work in a dynamic environment, collaboration with different teams, knowledge and experience sharing within the global Novartis system. You are kindly encouraged to submit your application in English and Slovenian language. 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: Add € 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. In addition to your base salary, you will be eligible for benefits listed below: Annual bonus for all employees: 12% of annual base salary. Holiday allowance: In 2025 it amounted to €2,496 (net). For 2026 it amounts to €2,678.28 (net). Yearly performance-based bonus: In 2025 it amounted to €2,538.64 (gross), including the winter allowance. Voluntary supplementary pension insurance: Novartis in Slovenia provides voluntary supplementary pension insurance (5.844% of gross salary, capped annually at €3,054.65). Additional accident insurance: During employment at Novartis, the employee is insured 24/7 in the event of death or disability resulting from an accident. Specialist insurance: Group health insurance providing faster access to specialist healthcare services at Triglav Health Insurance Company d.d. for you and your family members. Care Connect: A program offering confidential, personalized support for mental health and well-being through therapy, counselling, tools, and more. Other benefits in accordance with legislation and collective agreements: Transportation, meal allowance, and other supplements. Read our brochure to learn more about our global total rewards offering: https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf 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. Vaše glavne delovne odgovornosti: Načrtovanje in vodenje proizvodnje, testiranja in sproščanja celičnih bank v skladu z GxP standardi, pregledi in odobritve izpolnjenih proizvodnih ali analitskih poročil. Zagotavljanje skladnosti z regulatornimi zahtevami (ICH, FDA, EMA). Samostojno načrtovanje, koordinacija izvedbe (razporejanje dela med tehniki in analitiki). Priprava dokumentacije za proizvodnjo, testiranje in sproščanje celičnih bank vključno s podporno dokumentacijo (npr. ocene tveganja). Samostojno reševanje odstopov od dobre proizvodne prakse ter obvladovanje sprememb v GMP okolju. Delovati kot ključni proizvodni in analitski ekspert pri inšpekcijah in presojah. Vodenje evalvacije, razvoja in implementacije novih proizvodnih in analitskih pristopov ter izmenjava znanj na globalni ravni. Izobraževanje in mentoriranje sodelavcev. Aktivno prenašanje znanja in predstavitev znanstvenih ugo