Roberta Grassi Email & Phone Number

Siena, Italia

Hangzhou, Zhejiang, China

Short term assignment as member of the Quality Excellence Program (talented employee development program).- Support to establish the QC laboratory transfer plan including method transfer and smooth operation transfer- Build up the operation management process and documentation for the new lab to ensure overall operation activities are compliant and reliable as lean approach- Lead project team meetings and coordinate actions among the different labs to ensure prioritization and… Show more Short term assignment as member of the Quality Excellence Program (talented employee development program).- Support to establish the QC laboratory transfer plan including method transfer and smooth operation transfer- Build up the operation management process and documentation for the new lab to ensure overall operation activities are compliant and reliable as lean approach- Lead project team meetings and coordinate actions among the different labs to ensure prioritization and respect of due dates in compliance with requirements Show less

Siena

• Responsible of providing Quality Oversight and Quality Leadership into all stages of development life cycle of vaccines as part of multifunctional and multicultural project teams working on Company’s high priority Projects• Ensure that phase-Appropriate Quality Standards and Systems are applied during development Life cycle, in preparation and startup of commercial launch phase• Ensure that regulatory commitments are properly addressed and timely implemented• Ensure efficient… Show more • Responsible of providing Quality Oversight and Quality Leadership into all stages of development life cycle of vaccines as part of multifunctional and multicultural project teams working on Company’s high priority Projects• Ensure that phase-Appropriate Quality Standards and Systems are applied during development Life cycle, in preparation and startup of commercial launch phase• Ensure that regulatory commitments are properly addressed and timely implemented• Ensure efficient interaction and an appropriate information flow with internal and external stakeholders involved in the project Show less

Florence Area, Italy

• Decision making for Formulation and Dispensing Quality Assurance Issue • Impact assessment on product, Investigation/Review/Approval of Deviations• Approval of procedures, recipes (washer, autoclave, SIP), protocols• Batch Review/Disposition and release of Insulin cartridges • Contact Person in Agency and Corporate Inspections

Sesto Fiorentino - Firenze - Italia

• Management of a team of 10 senior and junior analysts • Coordination and decision-making for all biological activities ,• Supervision of a wide range of analysis including sterility, preservative efficacy, potency, particulate matter, fertility, total count, crystal size/check, media fill reading,• Analytical disposition and release of Eli-Lilly’s products,• Approvals of environmental monitoring data• Investigations and approvals of OOS and OOT• Review/Approval of… Show more • Management of a team of 10 senior and junior analysts • Coordination and decision-making for all biological activities ,• Supervision of a wide range of analysis including sterility, preservative efficacy, potency, particulate matter, fertility, total count, crystal size/check, media fill reading,• Analytical disposition and release of Eli-Lilly’s products,• Approvals of environmental monitoring data• Investigations and approvals of OOS and OOT• Review/Approval of procedures, protocols, methods of analysis respecting Pharmacopeia’s guidelines, • Review/Approval of production validation protocols Managing a multi-project team, coordinate activities with Chemical Lab and Lab Device/incoming for analysis Release, cooperate with French and American sites to uniform methods of analysis. Show less

Medical Center - New York

• Cellular culture, cell transfection and infection on human and rodent immortalized cell lines and primary culture• Bacterial Transformation, clone selection• DNA subcloning, DNA extraction from tissues, PCR, RNA extraction Real-Time PCR, Northern Blotting, luciferase essay, cell lyses, Western blotting, immunoprecipitation.Worked in a multinational laboratory. Required to analyze research articles, present them to post-docs and various NYU attendees, conduct Q&A sessions, and… Show more • Cellular culture, cell transfection and infection on human and rodent immortalized cell lines and primary culture• Bacterial Transformation, clone selection• DNA subcloning, DNA extraction from tissues, PCR, RNA extraction Real-Time PCR, Northern Blotting, luciferase essay, cell lyses, Western blotting, immunoprecipitation.Worked in a multinational laboratory. Required to analyze research articles, present them to post-docs and various NYU attendees, conduct Q&A sessions, and provide conclusions and ideas to the Head of NYU Dept. of Microbiology. Show less

Paris Area, France

Internship in the Research, Development and Production Center, Recombinant Proteins Team:• Fermentation techniques to optimize the production of a target protein used in oncology. Strand utilized: Escherichia coli.• Scale up production from tube to seven-liter bio-reactor• Electrophoresis and quantification of the protein samples • Affinity micro-purification using Ni-Cl charged Micro-columns and Agarose matrix with Ni-NTA charged magnetic balls (through a bio-robot)Worked… Show more Internship in the Research, Development and Production Center, Recombinant Proteins Team:• Fermentation techniques to optimize the production of a target protein used in oncology. Strand utilized: Escherichia coli.• Scale up production from tube to seven-liter bio-reactor• Electrophoresis and quantification of the protein samples • Affinity micro-purification using Ni-Cl charged Micro-columns and Agarose matrix with Ni-NTA charged magnetic balls (through a bio-robot)Worked in an experienced team of one of the world largest pharmaceutical companies. Required to interact with the team, present creative ideas and update Aventis’ Managing Director on the development and results of the research. Show less

Fifteen-month internship in a research and production laboratory, working in a sterile department with 10000 and 100000 filtering classes. • Mammalian cellular culture• Polyclonal/monoclonal antibody production• Antibody purification (Fast Protein Liquid Chromatography)Worked in a small and challenging team where attentions to the detail, cost-efficiency and risk-reward analysis were key drivers.

Master, Molecular And Cellular Biology

Activities and Societies: Transcriptional regulation of SOX2 gene upon FGF treatment in osteoblasts Investigate mechanisms by which FGF.

Engineering, Industrial Biotechnology

Thesis: “Studies of adaptation and growth of hybridoma and myeloma cells in serum free media” Purpose: Compare growth, sensitivity.