Kristine Wößner

Lead diverse groups of CMO’s (service providers) and multi-disciplinary teams in the technology transfer, development and production of non-clinical and clinical supplies (Phases I-III). • Provided technical expertise and support during process development, scale-up, and cGMP manufacturing. • Reviewed and approved master and executed batch records, in-process methods, protocols, and reports.

Hands-on experience in research, formulations, and lab-scale process development. Developed stability indicating analytical methods and procedures, chemical/physical characterization, and sterile compounding and filling of drug product supplies. • Established and configured equipment for laboratory, as well as performed and interpreted data for various analytical techniques: HPLC (UV, RI), DSC, XRPD, TGA, DVS, UV-vis, viscometery. • Design-of-Experiments and statistical analysis.

Project management in the areas of CMC, clinical manufacturing, and and clinical packaging and labeling.

Project: Developed a Dried Matrix Spot assay for measuring drug concentrations in synthetic cerebrospinal fluid (CSF) using HPLC-MS/MS for detection. Used Design-of-Experiments for assay development and data analysis.

Undergraduate Student Researcher at UI Chemical & Biochemical Engineering, Participant for Program for Enhanced Design Experience (PEDE) with Genencor Intl., Student Technician for Pharmaceutical Services.