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Scientist Early Translational Sciences

vor 4 Wochen


Munich, Deutschland Novartis Vollzeit

2023 will potentially see Sandoz become a standalone organization Already a global market leader in Generics and Biosimilar medicine, this is an exciting, once-in-a-career opportunity to set our own path forward as an independent, purpose-driven organization, and as the founders of a new Sandoz, this is a time of immense opportunity for us all, both professionally and personally
Together we will shape the future of Sandozare you ready to make a difference?
8 biosimilars across immunology, oncology and endocrinology are already on the market, Sandoz Biopharmaceuticals has a leading biosimilars pipeline with additional molecules in various stages of development. As Preclinical Development Manager, you contribute to the future success of our biosimilar development. You are responsible for providing nonclinical expertise to assigned global cross-functional biosimilar program teams, leading the timely planning and execution of innovative and tailored nonclinical development programs.

**Your key responsibilities**:

- Independently plan, organize, perform and document experiments for the development and qualification of in vitro cell-based bioassays and immunoassays for functional characterization of biosimilars in alignment with the nonclinical in vitro strategy of the projects.
- Manage operational aspects in lab:

- Take over responsibility for and utilize special equipment (e.g. flow cytometer) or specialized facilities as an expert; schedule and perform maintenance and qualification of analytical instruments/equipment.
- Actively maintain laboratory inventory (e.g. chemicals, standards, consumables) within own area of responsibility.
- Work according to appropriate standards as defined in Quality Manual, SOPs, health, safety, environment (HSE), and information security (ISEC) guidelines; lead initiatives to proactively ensure compliance and continuous improvement.
- Provide documentation of raw data, evaluate and interpret results; propose and provide input for the design of next experiments. Review and verify raw data generated by others; approval of test/experiments performed by others.
- Write documents, e.g. study plans and reports or lab procedures / SOPs based on templates under mínimal supervision.
- Recognize, communicate, address and solve problems (e.g. deviations and unexpected results from experiments) within own and broader area of responsibility; actively transfer know-how or procedures to other departments or external contractors, including troubleshooting (if needed).
- Develop new methods/processes or optimize existing methods/processes.
- Contribute to evaluation and implementation of new technologies.
- Perform information and literature searches under mínimal guidance. Actively foster knowledge exchange. Train and coach associate scientists, technicians, temporary employees and employees under training/education.
- Present scientific/technical results internally.
- Coordinate assigned project tasks and responsibilities under supervision.
- Collaborate within own and with other groups.
- Proactively identify conflict situations and contribute with empathy to solutions.

**Commitment to Diversity & Inclusion**:

- Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve._

**Minimum requirements**

**What you’ll bring to the role**:

- PhD, or MSc in Biology, Biotechnology (or related Natural Sciences) with 2 years of relevant experience, or

BSc in Biology, Biotechnology (or related Natural Sciences) with 4 years relevant experience
- Excellent communication skills in English
- Proficient practical experience with cell-based bioassays as well as bioanalytical techniques (e.g. ELISA, ECL immunoassays, flow cytometry, luminescence)
- Experience with assays using primary cells is a plus
- Deep knowledge in development and validation of potency assays incl. regulatory guidelines and requirements is a plus
- Knowledge in structural biology / protein modeling, phys-chem analytical methods, and/or biosimilar development is a plus
- Good theoretical and scientific knowledge in the relevant area
- Excellent knowledge of relevant software tools, e.g. PLA
- Good skills in presentation and advanced scientific writing skills
- Experience with working in a regulated environment is a plus

**Desirable Requirements**:

- German is a plus

**Why Sandoz?**
500 million patients were touched by Sandoz generic and biosimilar medicines in 2020 and while we’re proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.
How will we do this? We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by


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