Analytical and Formulation Scientist, Pharmaceutical Research and Development

Job Description

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 and physiochemical 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.

Job Requirements

• A minimum of a bachelor’s degree in chemistry/chemical engineering/material engineering or a related field. 
• At least 5 years of experience in the pharmaceutical industry, including a minimum of 3 years in analytical R&D and at least 2 years of hands-on experience with HPLC testing.
• Experience in qualification of test methods, protocols and reports writing.
• Demonstrable organizational skills; Flexible and methodical approach to work.
• Proficiency with the English language. 
• Self-confidence and motivation to investigate and solve complex problems.
• Ability to prioritize and schedule work to meet timelines.
• Presentation skills and the ability to convey technical information.
• IT and technological skills to work with advanced equipment and techniques.
• Creativity and resourcefulness and ability for independent work. 
• Effective teamworking skills.
• Skilled in GMP, able to perform tasks in compliance with quality and safety standards.
  
  

• 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.
• Being active member of the safety Committee at UroGen.