Scientist (f/m/d) in vitro DMPK

at  Nuvisan GmbH

QUALIFICATIONS

PhD / post-doc in life sciences (e.g. chemistry, biochemistry, pharmacy) or equivalent
In-depth knowledge and hands on experience with in vitro ADME studies i.e. distribution, metabolism, and transporter studies.
Profound experience in bioanalytical LC-MS/MS methods
Profound knowledge of international regulatory guidelines for in vitro DMPK and drug-drug interaction evaluation from EMA, FDA, ICH in particular
Collaborative, self-driven and enthusiastic personality with excellent communication and presentation skills, capable to work both as team player and project driver.
Excellent communication in English (written and spoken), advanced knowledge in German

Planning, conducting, evaluating, and reporting of the following in vitro ADME experiments in adequate quality and in compliance with delivery timelines:

• Protein binding
• CYP inhibition & induction
• Whole blood distribution
• Microsomal and hepatic clearance
• Drug transporter investigations

Review and interpret analytical data and take responsibility for accuracy and compliance.
Leading all aspects of studies to ensure data accuracy and report quality
Assisting in the preparation of presentations, customer visits and audits
Identify issues and provide technical troubleshooting in in vitro ADME experiments
Ensure compliance with regulations (e.g. GxP guidelines, radiation protection) in relation to R&D processes, study conduct and drug registration
Creation of quality-relevant documents such as SOPs