Barbara Pinto

Supervision of a team of 3-6 members involved in process development and analytical characterisation of Active Pharmaceutical Ingredients (APIs), including: • development of manufacturing pathways for new APIs (laboratory scale); • transferring of methods to the pilot or industrial team, comprehensive of critical parameters study, product or intermediate stability study, cleaning procedures; • development of analytical methods for the characterisation and quality control of the new APIs

Development of analytical methods and procedures for new manufacturing processes including: • development of analytical methods for characterisation and quality control of starting materials, intermediates and drug substances; • development of analytical methods for in process controls; • planning and execution of analytical method validations; • execution of analytical tests related to scaling up processes, tabulation and presentation of results.