As a Senior Expert in the Method Development Team in Process Analytical Sciences (PAS), you will be responsible for physical chemical method development, optimization, and robustness testing in late-phase pharmaceutical drug development. We work with state-of-the-art technologies to develop methods for new biopharmaceutical entities by applying scientific expertise to enable Drug Substance (DS) and Drug Product (DP) process development within a multidisciplinary project team. We are seeking an experienced scientist with strong analytical expertise, proficiency in data and digital tools, and deep knowledge of DS and DP process development. The role will be a mix of experimental laboratory development work and authoring documentation. As such, the adecuado candidate should be comfortable working in a hybrid environment both in and out of the laboratory.Join our Analytical Development team in Schaftenau and help shape the future of healthcare. Let’s continue to build on our momentum, and make an extraordinary impact, together.
LI-HybridLocation - Schaftenau, Austria
This role is based in Schaftenau, Austria.
Novartis is unable to offer relocation support: please only apply if accessible.
Key Responsibilities:
- Plan, organize, perform and document physical chemical method development, e.g., HPLC and CE, in compliance with internal quality standards and HSE requirements.
- Knowledge and experience with various software tools, e.g., chromatographic or statistical software to increase efficiency.
- Support the implementation, handover and transfer of analytical methods to internal teams and external partners (e.g., CROs).
- Collaborate with internal development (PAS) laboratories, Analytical Experts (AE), and cross-functional teams to ensure seamless execution of analytical workflows.
- Design and execute physicochemical analytical approaches for DS, DP and process intermediates ensuring compliance with Quality by Design principles.
- Interpret and contextualize analytica