Analytical development scientist

3/2015 – 3/2016

Development of analytical methods to identify all the impurities associated with API using uHPLC-UV and uHPLC-MS systems.
 Analytical method development and method validation in accordance with the appropriate regulatory guidelines (Novartis SOPs, FDA, ICH), and practical considerations to ensure that the method is robust and can be transferred to laboratories across all sites.
 Forced degradation studies on API.
 Collaboration with multifunctional teams as chemists, involved in the synthesis of the drug substance, and laboratory technicians, involved in the validation tests.

Hardware-Design, IT-Techniker (allg.), Rechnergestütztes Betriebsleitsystem (RBL), Filtertechnik, Techniker (allg.), CAN-Bus (controller area network), Arbeitszeit- / Gleitzeitsysteme, Chemie

5/2013 – 3/2015

Development and validation of several HPLC methods to quantify antibiotics in biological matrices for routine and research analyses.
 Writing of documentation, including procedures, protocols and reports accordingly to EN UNI ISO 9001:2008.
 Analytical method development and method validation in accordance with the appropriate regulatory guidelines (FDA, ICH, EMEA).
 Long term stability studies of antimicrobials in biological matrices.
 Supervision of a laboratory team composed of 4 scientist and 1 technician.
 Collaboration with multifunctional teams as clinicians, pharmacists, nurses.
 Train and supervise master degree students in Pharmacy, Biology, Biotechnology, Biomedical Laboratory Technician, Chemists.
 Collaboration to the laboratory certification EN UNI ISO 9001:2008 for “Planning, development and application of methods to quantify anti-infective drugs”.

Hardware-Design, IT-Techniker (allg.), Schulung / Training (IT), Filtertechnik, Techniker (allg.), Biotechnologie, DIN EN ISO 50001, DIN EN ISO 9001, Autor / Schriftsteller, Forschung & Entwicklung, F&E Management, Biologie, Chemie

1/2009 – 1/2013

Development and validation of several HPLC methods to quantify antibiotics in biological matrices for routine and research analyses.
 Writing of documentation, including procedures, protocols and reports accordingly to EN UNI ISO 9001:2008.
 Analytical method development and method validation in accordance with the appropriate regulatory guidelines (FDA, ICH, EMEA).
 Long term stability studies of antimicrobials in biological matrices.
 Supervision of a laboratory team composed of 4 scientist and 1 technician.
 Collaboration with multifunctional teams as clinicians, pharmacists, nurses.
 Train and supervise master degree students in Pharmacy, Biology, Biotechnology, Biomedical Laboratory Technician, Chemists.
 Collaboration to the laboratory certification EN UNI ISO 9001:2008 for “Planning, development and application of methods to quantify anti-infective drugs”.

DBASE, Hardware-Design, IT-Techniker (allg.), Schulung / Training (IT), Filtertechnik, Techniker (allg.), Biotechnologie, DIN EN ISO 50001, DIN EN ISO 9001, Autor / Schriftsteller, Forschung & Entwicklung, Biologie, Chemie