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

Job Description

Industry: Pharmaceutical Manufacturing
Seniority for this role: Mid-Senior level
Job Description Sandoz, of which Lek is also a part, is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines. Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for us, the Sandoz and Lek associates. This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally. The role is part of Biopharma Technical Development and will be based in Slovenia. Our aspiration is to be innovative in applying science to develop formulations, technologies and processes that will enable production of high quality biosimilar drug products. We are looking for a Leading Scientist Pharmaceutical Development Biosimilars (d/f/m) with project management experience in drug product formulation development, process development and process transfers for biosimilars. Your Key Responsibilities Your responsibilities include, but not limited to: Drug product development according to assigned project workpackages and in alignment with project strategy, objectives and timelines. Leading of Drug Product (DP) development project activities and alignment of activities between functional experts, team leaders, and project management. Leading of process transfers to/from Manufacturing Organizations for clinical and commercial manufacturing at external and internal partners. Interpret results, evaluate data and draw relevant conclusions; supervise project-related scientific activities and challenge conclusions made by other scientists. Act as a technical expert in audits, inspections, alliances and/or due diligence activities as needed. Contribution to technical project team meetings, timely reporting of project achievements, issues and risks including risk mitigations to project management and line function stakeholders.Leading or supporting root cause investigations. Contribution to long term DP development strategy especially in the filed of process transfers and late phase process development, continuous improvement of DP development platform, development manuals and global initiatives related to development of biologics drug product. Ensuring compliance of activities with standards in the field of quality (GMP), in the field of ensuring health and safety at work and other Sandoz standards. What You Will Bring To The Role Master or Doctoral degree in relevant natural science such as molecular biology, chemical engineering, biochemistry or biotechnology. 5 years of working experience in the field of drug product development of biologics/biosimilars, ideally experience in the filed of process transfers and late phase process development. Fluency in oral and written English. Project management skills. You’ll Receive Employment at the most reputable employer in Slovenia offers 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 (Energized for Life), Unlimited learning and development opportunities. Possible job locations: Slovenia (Ljubljana) We offer permanent contract with 6-month of probation period . You are kindly invited to submit your application in English language, including CV, by January 31st, 2025. Why Sandoz? Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more! With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably. Our momentum and entrepreneurial spirit 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 with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged! The future is ours to shape! Commitment To Diversity & Inclusion Sandoz is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve. Join Our Sandoz Network If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Sandoz and our career opportunities, join the Network here: https://talentnetwork.novartis.com/sandoztalentpool #Sandoz #BioRampUp Show more Show less