Report to Vice President of Research, Development and Innovation.• Evaluation of API producers• Tech-transfer, Analytical methods and process development• Validation of process and analytical methods• Integrative approach for biotechnology dossier submission• Quality assurance of biosimilar DS and DP• R&D for biosimilars production• Support for R&D and QA/QC teams

Departamento de Bioingeniería. Escuela de ingenieria y ciencias.

• Administration and operative supervision in a GLP laboratory. • Development and implementation of analytical methods (qualification and validation). • Writing and execution of validation protocols. • Leader of a multidisciplinary group of 14 people including support to QA. • Technical advice for biosimilar comparability studies including dossier revision and submission.• Design and execution of comparability studies for more than 25 different biosimilars.• Implementation and maintenance of ISO-900-2015 and ISO-IEC-17025.• Member of the New Molecules Committee and the Sub-committee for the Evaluation of Biotechnological Products of COFEPRIS (2016 to date).• Academic advisor for Bachelor and postgraduate students• Preparation and revision of institutional collaboration agreements.• Academic collaboration with several Institutions, INMEGEN, Biomedical Institute, UDIBI, UNIPREC, and others. Advisor for different companies in the development of biosimilars.• Invited speaker at different forums (academic and regulatory)

• Development and implementation of analytical methods for antibody characterization, DS and DP.• Physicochemical characterization of monoclonal antibody.• Student Advisor