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Roberta Genga, PMP®

Roberta Genga, PMP®

Assistantship

Followers of Roberta Genga, PMP®1000 followers
location of Roberta Genga, PMP®Guidonia Montecelio, Latium, Italy

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  • Timeline

  • About me

    Qualified Person & Head of Product Quality Expert presso Healthcare Business of Merck

  • Education

    • Liceo Scientifico Lazzaro Spallanzani

      2001 - 2006
      Scientific certificate Progetto Brocca Scientifico Tecnologico 91/100

    • Sapienza Università di Roma

      2014 - 2014
      Post-graduate course - Master II level Industrial Pharmaceutical Methodologies 110 con lode

      Activities and Societies: Thesis "The management of Change Control Process"

    • Università degli Studi di Roma 'La Sapienza'

      2006 - 2013
      Master's degree Chimica e Tecnologia Farmaceutiche 105/110

      Degree Thesis "THERMAL ANALYSIS OF RECOMBINANT PROTEINS FOR THERAPEUTIC USE"The aim of the work has been the development and application of an analytical method of calorimetric type for the characterization of samples of protein nature, based on the use of the nanoDSC instrument. I applied the method to several studies, with the aim to evaluate: comparability among samples derived by several manufacturing processes; changes in the thermal behavior induced by structural changes; thermal… Show more Degree Thesis "THERMAL ANALYSIS OF RECOMBINANT PROTEINS FOR THERAPEUTIC USE"The aim of the work has been the development and application of an analytical method of calorimetric type for the characterization of samples of protein nature, based on the use of the nanoDSC instrument. I applied the method to several studies, with the aim to evaluate: comparability among samples derived by several manufacturing processes; changes in the thermal behavior induced by structural changes; thermal behavior in a stability study.Immunology, Biotechnology, physical chemistry, biological chemistry, pharmaceutical chemistry, analytical chemistry,biochemistry,organic chemistry, pharmacology, pharmaceutical techniques Show less

    • GEMA Business School

      2019 - 2020
      Executive Master Project Management

  • Experience

    • University of Rome "La Sapienza" - Dipartimento di Microbiologia Farmaceutica

      Oct 2009 - Nov 2010
      Assistantship

      Preparation of growth medium for fungi and measuring population concentration by OD (Candida and Aspergillus)Distribution of books and magazines, labeling and accommodation volumes, user control, and assistance for research and bibliographic information on the catalogs and online databases; collaboration in the management of computer services; cooperation in updating the databases and catalogs for students.

    • Pharmacy

      Aug 2010 - Mar 2011
      Professional Internship

      Carrying out tasks related to professional training: Assistance to the bench (dispensation of medical repeatable and non-repeatable drugs prescriptions), assistance to the measurement of pressure, assistance in the galenicals laboratory .

    • Merck Serono R&D

      May 2012 - Apr 2013
      Internship

      R&D - Analytical Development - Protein Chemistry Department - Structural & Biophysical Characterization LaboratoryStructural characterization of proteins / antibodies and recording of experimental data using computer tools in accordance with GMP guidelines. Chemical-physic method development of nano DSC (Differential Scanning Calorimetry) for structural characterization. Evaluation of the behavior and thermal stability of protein molecules. Investigation on the role of glycosylation and oxidation denaturation. Rating thermodynamic parameters for the structural characterization. Kinetics of denaturation. Evaluation of the effect of the buffer on the thermal stability of proteins.Stability studies of formulations.Chromatography.Protein deglycosylation.Proteomics.Internship to preparation of Degree Thesis - Title: Thermal Analysis of recombinant proteins for therapeutic use Show less

    • Merck Serono

      Jul 2013 - Mar 2016

      Analytical Development QC & Stability CenterTechnology Transfer & Troubleshooting Laboratory Analytical Development QC & Stability CenterPhysical Chemical LaboratoryHPLC, UPLC, GC, peptide mapping, glycan mapping, N-Terminal, protein purity, stability studies, UV spectrophotemetry, fluorimetryAnalysis process for bulk, raw materials, finished products and stability samples.Preparing and review SOPs, Change Control and Investigations

      • Junior Researcher - Technology Transfer

        Jul 2014 - Mar 2016

      • Junior Researcher

        Jul 2013 - Jun 2014

    • Merck Group

      Apr 2016 - Sept 2020

      Analytical Development QC & Stability CenterTechnology Transfer & Troubleshooting LaboratoryTechnology transfer project on internal site or for external contractors (Switzerland, UK, Korea, Russia, Germany, Lithuania, Iran).Management of projects: transfer methods, writing protocols and final reports.Troubleshooting of analytical methods of IMP molecules.Development and Industrialization of chemical process.Research of operative solutions to improve the productive processes and to optimize the working schedule of the production area, complying with the quality control. Show less

      • Technology Transfer & QC CRO Project Expert

        Dec 2017 - Sept 2020

      • Associate Researcher - Technology Transfer

        Apr 2016 - Sept 2020

    • Merck Healthcare

      Sept 2020 - now

      • Head of Product Quality Expert & Qualified Person

        Dec 2024 - now

      • Qualified Person and Product Quality Expert

        Jan 2024 - Dec 2024

      • Product Quality Expert

        Sept 2020 - Dec 2024

  • Licenses & Certifications

    • Pharmaceutical Statistics and Statistics for Quality Control Laboratory

    • Enrollment in the National Professional Register of Pharmacists

      FOFI
      Jan 2016

    • Cambridge Certificate Level B1 - Final Mark:78/100

      Cambridge University Press
      Dec 2015

    • Bulats Certificate Level B1 - Business English

      Cambridge University Press
      Aug 2015

    • Statistica di base per la ricerca scientifica con il software STATA

      Catholic University of Sacred Heart
      Dec 2013

    • Qualification in Practice PharmacState examination for license to practice as a pharmacist, Final Mark: 297/350

      FOFI (Federation of the Order of Italian Pharmacists)
      Jan 2013

    • Corso base GMP: Capire le procedure GMP

      QA Merck Serono
      Jun 2012

    • Training Formativi e Operativi GxP

      QA Merck Serono
      May 2012

    • European Computer Driving Licence (ECDL)

      May 2005

    • Aknowledgement as Qualified Person

      AIFA Agenzia Italiana del farmaco
      Dec 2017

  • Honors & Awards

    • Awarded to Roberta Genga, PMP®
      Cash award for "Primo premio Igino Giordani" - Dec 2005 Assay title "Il controllo della comunicazione minaccia e condiziona la libertà di stampa e l'autonomia della professione giornalistica"
    • Awarded to Roberta Genga, PMP®
      Cash award for "Secondo Premio Igino Giordani" - Dec 2004 Assay title "Liberi da ogni schiavitù, nel III millennio"