Francesca Merangolo Email & Phone Number

Visp, Vs, Ch

Basilea, Svizzera

Siena, Italia

Lead the development of potency and quantification bioassays in a Quality By Design FrameworkApprove stability and release analyses for Tox, Phase I and Phase II lotsImplement standard bioassays to new technologies i.e. Octet, Luminex

Siena

Analytical method development and optimization according to QbD principles on glycoconjugate vaccines, with specialization in HPAECDirect involvement during Regulatory inspections as platform expertOperative responsible of HPAEC platform, providing guidance to other team membersCollaboration with managers and senior scientific staff to implement lab activities, interpret data and communicate the information to stakeholdersTechnical Report scientific review for HPAEC platformReferent for LIMS->GLIMS in TRD (implemention to global standards)Method validation, with coordination role and writing and management of GMP Documentation (VP, VR, QP, QR)Characterization activities on glycoconjugates drug substances, drug products and intermediates Collaboration with QA for DR, investigation and CAPA management (Sentry)

Siena

Optimization and validation of analytical methods on glycoconjugate vaccines (use of HPAEC, HPLC, spectrophotometer, capillary electrophoresis)Coordinator for the implementation LIMS-->GLIMS system in TRD and trainer to other usersRelease and stability analyses on Glycoconjugates vaccines and intermediatesResponsable of chemical reagents, check of safety data sheets and collaboration with HSA for the Risk evaluationGMP documentation (i.e. SOPs, Validation Protocols and Reports) and Technical Reports drafting

Optimization of DNA extraction from food matrices Development of PCR Real-Time assays for the identification and quantification ofthe plant and/or microbiological varieties in oil and honeyOptimization of a method for the identification and quantification of OGM incommercial honey Optimization of a method for the identification and quantification of OGM in commercial oilDevelopment of AFLP markers in onion (Allium cepa) for the selection withmolecular markers

M. Sc. Degree, Industrial Biotechnologies, Biochemistry, Molecular Biology, Chemistry, Genetics, Microbiology, Statistics, 110 Cum Laude

Genetics, industrial biotechnologies, biochemistry, molecular biology, analytical chemistry

2Nd Level University Master Degree, Toxicological Risk Evaluation (2011)

Evaluation of the toxicity of the individual chemical ingredients of the formulation used to manufacture the product and consideration.