Overview
As a Senior Expert in PAS Method Development, you will advance physical-chemical method development, optimization, and robustness testing for late-phase drug development. You’ll apply analytical expertise and digital tools within a cross-functional team to accelerate DS and DP process development. The role combines hands-on laboratory work with authoring technical documentation and supporting regulatory submissions. You will drive method transfer, DoE-based method innovation, and digitalization efforts to improve quality and efficiency. This is a hybrid role in Schaftenau, offering the chance to shape scalable analytical solutions in a leading biopharma environment.
Leistungen / Benefits
- market-competitive base salary
- incentive program
- pension scheme
- childcare facilities
- learning and development opportunities
- worldwide career possibilities within Novartis
Verantwortungsbereiche
- Plan, perform and document physical chemical method development (e.g., HPLC and CE) in line with quality standards and HSE requirements
- Utilize chromatographic or statistical software to improve efficiency
- Support transfer of analytical methods to internal teams and external partners (e.g., CROs)
- Collaborate with PAS laboratories, Analytical Experts, and cross-functional teams to execute analytical workflows
- Design and execute DS/DP/Process intermediate analyses following QbD principles
- Interpret results and apply data/digital solutions to boost efficiency
- Lead or support root cause investigations and issue resolution
- Author/review scientific reports and support regulatory submissions; act as analytical expert during audits
- Manage multiple priorities and communicate challenges proactively
- Promote knowledge sharing and contribute to publications, presentations, and patents
- Evaluate new analytical technologies, develop innovative DoE-based methods, ensure alignment with standards
- Contribute to ongoing digitalization efforts and apply data solutions to improve quality and efficiency
Zentrale Anforderungen
- University degree in relevant natural sciences or engineering
- At least 6 years (MSc) or 3 years (PhD) in (bio)pharmaceutical industry
- Advanced knowledge in Analytical Development
- Expertise in Biologics DS/DP process development applying QbD
- Excellent collaboration, communication, and problem-solving skills
- Proficiency in spoken/written English; German beneficial
- Strong proficiency in digital technologies
- collaboration
- communication
- problem-solving
- HPLC
- CE
- DoE
Senior Expert, Science and Technology (F/M/D) Arbeitgeber: Novartis
Novartis in Schaftenau, Österreich, ist ein hervorragender Arbeitgeber, der eine dynamische und unterstützende Arbeitsumgebung bietet. Mit einem starken Fokus auf Mitarbeiterentwicklung und kontinuierlichem Lernen fördert das Unternehmen eine Kultur der Zusammenarbeit und Innovation. Die Möglichkeit, an globalen Projekten zu arbeiten und einen bedeutenden Einfluss auf die Gesundheitsversorgung zu haben, macht Novartis zu einem attraktiven Arbeitsplatz für Fachkräfte im Bereich Regulatory Affairs.
