Irene Cecchini

Experience

• 

  Healthcare Business of Merck

  Aug 2003 - now

  I work in Biotech Product Development division as manager of Extractables and Leachables and process/product Troubleshooting Laboratory, within Protein Chemistry dept. I am responsible for E&L studies on the final products container closure systems, final bulk/API storage containers, as well as for single use materials used within biotech products manufacturing processes. I am also responsible for the development and validation of analytical methods for process related impurities to support process validation of DS and DP. We also take care of the investigations and troubleshooting to support manufacturing sites.The analytical techniques we mainly use are liquid and gas chromatography and mass spectrometry and ICP-MS. We guarantee expert support to the drafting of regulatory modules for the product registration with respect to the parts of competence.We are active members of scientific Industries Consortia for E&L (ELSIE), BPOG. Show less Researcher in Physico -Chemical Characterization laboratory within Protein Chemistry dept. I am responsible for managing Extractables and Leachables studies on the final products container closure systems (CCS), final bulk storage containers, as well as for biotech products manufacturing processes. I am also responsible for the development and validation of GC and GC-MS is methods and for the implementation of analytical techniques for sub-visible particles testing and characterization. In our laboratory we do product physico-chemical characterization in terms of protein structure, and we study protein aggregation by orthogonal techniques as AUC, SEC-MALS, AF4-MALS, light scattering and MFI.I guarantee expert support to the drafting of regulatory modules for the product registration with respect to the part of competence.As expert for Extractables and Leachables and particles, I contribute to build relationships with the scientific community and industry partners as an active member of specific Industries Consortia for E&L (ELSIE), BPOG and SbVP. Show less I work in Biotech Product Development division, in Protein Chemistry dept. - the Analytical Methods Development laboratory. I am responsible for the developement of analytical methods for monitoring drug product critical quality attributes (as protein degradations forms, aggregation..), for the implementation of analytical techniques for monitoring subvisible particles, and for carrying out extractables and leachables studies.The analytical techniques we mainly use are liquid chromatography or gas chromatography and mass spectrometry. Show less

  • Advanced Scientist

    Jun 2019 - now

  • laboratory manager

    Sept 2016 - May 2019

  • Researcher and technology specialist

    Jan 2014 - Sept 2016

  • Researcher

    May 2011 - Jan 2014

  • Associate Researcher

    Apr 2008 - May 2011

  • Junior Researcher

    Aug 2003 - Apr 2008