Analytical and Formulation Scientist

This position is a hands-on role within UroGen's R&D chemistry laboratory. The role entails designing and executing lab testing activities and R&D studies, using a range of analytical, physiochemical and biological methods, to support products in various developmental stages, while collaborating with project managers in the Pharmaceutical R&D department. Evaluating and interpreting the data and presenting results at department and cross-functional team meetings. In addition, the role involves collaborating with QA on the laboratory working standards to match quality requirements. Responsibilities • Design and perform analytical testing as part of R&D studies, including the preparation of product samples and formulations, as well as routine analysis and characterization of samples, while adhering to laboratory/pharmacopeial procedures, ensuring that accurate and timely analytical results are provided. • Set-up, operate, troubleshoot and maintain analytical lab equipment, including, but not limited to, high-performance liquid chromatography HPLC, dissolution apparatus, spectrophotometer, pH-meter and rheological instruments, e.g., viscometer and rheometer. • Plan and execute the development and modification of products, e.g. admixtures, preparation procedures. • Appropriately record all lab activities in lab notebook and/or electronic files, while meeting good laboratory and manufacturing practice (GxP) rules when recording data. • Being responsible for the equipment and materials policies, e.g., calibration and equipment list as well as the poisons permit. • Write and review protocols, testing plans and SOPs. • Record and summarize and/or review data in the form of spreadsheets, reports and presentations. Interpret the data and draw conclusions. • Perform qualification of analytical methods. • Develop and/or optimize analytical methods. • Participate in analytical methods transfer to external laboratories, as necessary. • Participate in formulation and manufacturing process development activities, mainly by supporting analytical testing. • Provide training and guidance to lab associates. • Work collaboratively in cross-functional teams, liaising with staff and suppliers. • Be aware of, and keep up to date with, health and safety issues. • Log and monitor stability data of commercial and clinical phase products. Perform statistical analysis of the data. • Participate in preparing documentations for regulatory submissions, setting specifications for raw materials, in-process and finished products. • Independently order chemicals and all required materials for routine and constant laboratory work and maintain an up-to-date lab inventory. • Perform other duties as required, e.g., organize shipments, literature searches, formulation development etc. as necessary.