Leading Scientist in Pharmaceutical Development (d/f/m)

Job description

Job Description Summary Join us in helping to make healthcare fairer and faster. / Pridružite se nam in nam pomagajte povečati pravičnost in hitrost zdravstvenega varstva. Job Description As a Leading Scientist in Pharmaceutical Development (Sandoz Global Development - SGD) you will be responsible for independent conduct of activities in the development of sterile pharmaceutical products. The main focus will be on the development of processes and formulations for sterile products, solving complex technical challenges, providing operational management and scientific support for technology transfers, and preparing high-quality regulatory documentation for successful registration submissions. Your key responsibilities: Development of complex sterile formulations and aseptic processes in compliance with regulatory requirements, internal standards, good manufacturing practices (GMP), and business objectives. Independently design, plan, execute, document, and interpret complex experimental studies using state-of-the-art methodologies, including Design of Experiments (DoE) and statistical tools. Assessment of risks and expert support for sterility assurance activities, including understanding the critical links between the aseptic process, equipment, primary packaging, and product quality. Collaboration with internal and external experts in the areas of Manufacturing Science and Technology (MS&T), analytics, microbiology, quality, medical devices and regulatory affairs in the development and registration of sterile products. Lead troubleshooting activities for process and formulation development challenges, identifying root causes and implementing effective, scientifically sound solutions. Critically review and approve experimental results, preparation of reports, challenge assumptions, and provide scientifically justified recommendations and strategic direction. Proactively identify risks in development programs and drive mitigation strategies to ensure project timelines, quality, and budget targets are met. Prepare high-quality technological registration documentation (e.g., CTD modules), support responses to Health Authority questions (Deficiency Letters), and contribute to successful regulatory submissions. Evaluate, implement, and promote innovative technologies, methodologies, and equipment to enhance development efficiency and product quality. Lead or contribute to cross-functional project teams, providing scientific and technical guidance while fostering collaboration and knowledge sharing. Mentor and coach junior scientists, encouraging proactive thinking, innovation, and continuous development within the team. Providing conditions for and control of the implementation of HSE tasks and requirements in the unit. Communicating company vision and values; establish and manage good relationships with business partners. Other tasks determined during the annual objectives setting process and by KPIs. What you will bring to the role: Master degree in a pharmaceutical, chemistry or other relevant field. Minimum 6 years of relevant experience or 3 years in case of PhD from research & development or production area of sterile dosage forms. Fluent in English. Knowledge of Microsoft Office. Advanced theoretical and practical knowledge in the field of sterile pharmaceutical products, with a proven track record in technically leading complex projects. Practical experience with, or good knowledge of, aseptic manufacturing processes, process scale-up activities, and technology transfer to different manufacturing sites, including contract manufacturing organizations (CMOs). Good understanding of sterility assurance principles in pharmaceutical manufacturing and key regulatory expectations for sterile products, such as EU GMP Annex 1, aseptic processes, and contamination control strategy. What we offer: Job location: Ljubljana Contract type: permanent contract with 6-month probation period Expected weekly working hours: 40 *Pay range: €50,720 – €76,080 gross yearly *Salary at Sandoz is based on job level, qualifications, specific skills, and work experience. Fully proficient candidates are usually placed around the market median, less experienced candidates lower in the range, and those with strong or niche expertise higher. When determining placement within the range, we also consider internal pay equity and external market data. Our compensation package additionally includes: Annual bonus (STI): percentage of annual salary Vacation allowance: in 2025 it was €2,430.99 net Christmas bonus: in 2025 it was €2,100 gross OurShare: every year, an employee of Lek d.d. will be entitled to receive shares of Sandoz AG Voluntary Additional Pension Scheme: The company fully covers the contribution for your supplementary pension plan, amounting to 5.844% of your gross salary Allowance for shift work (15%); rotational shifts (20%), night shift work (70%), Sunday/public holiday work (50%), overtime work (30%) – if applicable for position Collective life and accident insurance (24/7 coverage) A hybrid work environment offering flexibility and remote work possibilities – if applicable for position Ready for your next career move? You are kindly invited to submit your application in English and Slovene, including a CV, by October 19, 2026. Why Sandoz? Sandoz is the global leader in Biosimilar and Generic medicines, a segment of the healthcare industry that delivers 80% of the world’s medicines at 30% of the cost, touching the lives of more than 1 billion people across 100+ countries! While we are proud of our achievements, we have the ambition to do more so that everyone can benefit from the basic human right of good health. With investments in new development capabilities, production sites, new acquisitions and partnerships, we have the opportunity to shape a sustainable future for Sandoz and to help even more people gain access to low-cost, high-quality medicines. Our momentum is powered by an open, collaborative culture driven by our talented and ambitious colleagues who, in return for applying their skills, experience an agile and collegiate environment where diversity of thought is welcomed and where personal growth is supported! Join us in helping to make healthcare fairer and faster. Commitment to Diversity & Inclusion: We are committed to building an outstanding, inclusive work environment and to forming diverse teams that are representative of the patients and communities we serve. #Sandoz ------------------------------------------------------------------------------------------- Vodilni raziskovalec v Farmacevtskem razvoju (d/ž/m) Kot Vodilni raziskovalec v Farmacevtskem razvoju (Sandoz Global Development - SGD) boste odgovorni za samostojno izvajanje aktivnosti na področju razvoja sterilnih farmacevtskih izdelkov. Glavni poudarek bo na razvoju procesov in formulacij za sterilne izdelke, reševanju kompleksnih tehničnih izzivov, zagotavljanju operativnega vodenja in strokovne podpore pri tehnoloških prenosih ter pripravi dokumentacije za uspešne oddaje registracijskih dosjejev. Vaše ključne odgovornosti: Razvoj kompleksnih sterilnih farmacevtskih oblik in aseptičnih procesov skladno z zakonodajo, internimi predpisi, dobrimi praksami in poslovnimi cilji. Samostojno načrtovanje, oblikovanje, izvajanje, dokumentiranje in interpretacija kompleksnih eksperimentalnih študij z uporabo sodobnih metodologij, vključno z načrtovanjem eksperimentov (DoE) in statističnimi orodji. Vodenje aktivnosti odpravljanja težav pri razvoju procesov in formulacij, identifikacija vzrokov težav ter implementacija učinkovitih in znanstveno utemeljenih rešitev. Ocena tveganj ter strokovna podpora pri aktivnostih zagotavljanja sterilnosti izdelka, vključno z razumevanjem kritičnih povezav med aseptičnim procesom, opremo, primarno ovojnino in kakovostjo izdelka. Medfunkcijsko sodelovanje z internimi in zunanjimi strokovnjaki na področjih proizvodne znanosti in tehnologije (MS&T),