Weimar, Thuringia, Germany
- Independent preparation of TRD/registration documentation for global submission - Ensure compliance to current scientific status - Implementation of complex global amendment regulatory specifications - Development and validation of analytical methods according to the current state of the art - Respond to regulatory inquiries from national and international drug regulatory agencies - Evaluation, revision and preparation of finished product monographs in various Internat. Pharmacopoeias - Lead-Site expert and point of contact for local and global functions - Technical responsibility and leadership of laboratory staff - Responsible for GxP compliant organization and implementation of all analytical work - Representation of direct supervisor in cross-functional and cross-site project teams
- Design, synthesis and characterization of organic battery materials. - In-depth knowledge of synthesis, analytics, electrochemistry and battery design - Independent preparation of several scientific articles, reports and lectures - Conceptualization, optimization and validation of a HPLC - method according to ICH and USP guidelines - Company cooperation with JenaBatteries GmbH and H.M. Heizkörper - Project planning and processing in cooperation with other institutes and universities - Leadership and guidance of several technicians as well as supervision of a large number of students
- HPLC analysis of drugs under GMP conditions. - Execution and planning of calibrations - Further training in the field of GMP