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- Scientific and technical management of the in vitro DDI-Profiling laboratory, including supervising personnel. Responsible for the resource-conscious deployment and work allocation of employees, supporting other laboratories in the event of bottlenecks, as well as for equipment, facilities, and support in investment planning. Monitoring and compliance with guidelines on, for example, laboratory safety, biological and genetic engineering safety.
- Design, coordination, optimization, and evaluation of studies to investigate e.g. CYP-inhibition and CYP-induction of test substances, as well as ensuring the provision of high-quality and timely results. Continuous development of methods/assays and processes, as well as their adaptation to customer specifications. Ensuring scientific expertise in the field of DMPK/ADME and, in particular, in the field of DDI.
- Collaboration in interdisciplinary research projects as a DMPK representative.
- Coordination of DMPK studies in close consultation with other internal functions or customers, evaluation, interpretation, and presentation of complex results in a project context. Training new employees and scientists.
- Supporting the Business Development function with regard to scientific support in the acquisition of new projects and orders (e.g., scientific customer contacts, preparation of quotations). Supporting the Finance function in billing for laboratory services.
- Ph.D. (or equivalent) in life sciences (chemistry, biochemistry, pharmacy) and postdoctoral experience
- Hands-on DMPK/ADME experience in pharma, biotech, or CRO environment, including leading small teams
- Deep knowledge of drug metabolism, enzymology, absorption, distribution, and in vitro ADME investigations
- Strong understanding of R&D practices; familiarity with cellular/molecular biology and chemistry relevant to in vitro DMPK
- Proven experience with quantitative bioanalytical methods (LC-MS/MS)
- Thorough knowledge of international regulatory principles and health authority guidelines (EMA, FDA, ICH), particularly for in vitro DMPK and DDI evaluation
- Experience with PK/PD modeling and simulation tools (Phoenix WinNonlin, SimCYP, GastroPlus) is beneficial but not required
- Excellent communication and presentation skills; collaborative, self-driven, and results-oriented; adept at building relationships internally and externally
- Fluent English (written and spoken), German is plus
