Americo Barbaro, PMP®

Experience

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  INT-CROM Pascale Foundation

  Apr 2012 - Jun 2014

  Determination of K-Ras mutation in mCRC patients in FFPE tissue. Determination of EGFR mutation in NSCLC patients in FFPE tissue. Determination of EGFR mutation in NSCLC patients in serum, plasma and CTC. Preparation of libraries from FFPE DNA and sequencing using Ion Ampliseq colon and lung cancer panel on NGS Ion PGM platformDetermination of BRAF mutation in melanoma patients in FFPE tissue. • Eukaryotic cell culture;• Molecular cloning;• Preparation of competent cells;• Extraction and purification of genomic DNA; • Extraction and analysis of genomic DNA from cell culture, FFPE tissue, peripheral blood, serum , plasma, CTC;• Extraction and analysis of RNA from cell culture, FFPE tissue; • Use of automatic extractors : Qiasymphony, Qiacube;• Quantification of nucleic acid by Nanovue, Nanodrop, Qubit® 2.0 Fluorometer e 2100 Bioanalyzer;• Site Directed Mutagenesis• Qualitative PCR, reverse transcription, RT-PCR, Q-PCR (Taqman technologies), allelic discrimination;• Nested PCR and exonic fragment analysis by capillary electrophoresis;• PNA-LNA PCR clamp;• DNA direct sequencing;• Use of sequencer 3500 Dx Genetic analyzer;• Preparation of libraries from FFPE DNA and sequencing using Ion Ampliseq colon and lung cancer panel on NGS Ion PGM platform.• Use of sequencer PyroMark Q24 MDx. Show less

  • Internship

    Nov 2013 - Jun 2014

  • Internal student

    Apr 2012 - Oct 2013
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  Pfizer

  Sept 2014 - Feb 2015

  Plant Technical Services

  Definition of the priorities and objectives of the Technical Services function within the project of transfer.Monitoring and follow-up of action plans that emerge from internal meetings and other interdepartmental meetings.Support in the preparation of documents (ppt, word, excel, enterprise computing platforms, such as SAP or JDE) to be submitted for review and approval of the relevant functions of the site.Management of activities related specifically to the development and validation in pharmaceutical manufacturing area, packaging and cleaning area, including activities to support and preparatory to carrying out the tests of pharmaceutical development and scale-up, in accordance with the procedures of site.Bibliographic research, in institutional or technical specialist sites (characterization and selection of input materials to use in the field of pharmaceutical formulation development).Training about operational procedures and business processes typical for development and validation of pharmaceutical products, within a company-sized corporations. Show less

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  AZIENDA OSPEDALIERA SAN GIUSEPPE MOSCATI

  Mar 2015 - May 2015

  Hospital Pharmacist

  Meeting with CRA. Ethical and legal issuesClinical Trial assistantData management and staticsMedical InformationDrug safety and pharmacovigilance/ pharmacoepidemiologyBiological and Advanced therapies.

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  Pfizer

  Jun 2015 - Nov 2015

  Plant Technical Services Expert

  Development and validation in pharmaceutical manufacturing area.Cleaning Validation.Preparation of documents (ppt, word, excel, enterprise computing platforms, such asSAP or JDE) to be submitted for review and approval of the Quality department. Collaboration and support for Regulatory affairs activities for the submission to Health Authority of the CTD dossier; good knowledge of the regulatory documents.Management of activities related specifically to the development and validation in pharmaceutical manufacturing area, packaging and cleaning area, including activities to carrying out the tests of pharmaceutical development and scale-up, in accordance with the procedures of site Show less

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  The Janssen Pharmaceutical Companies of Johnson & Johnson

  Dec 2015 - May 2016

  Technical Operations, Altran Consultant

  Technology Transfer.Development and validation of manufacturing process.New products introduction.Inferential statistics, Process Capability, (Minitab).Automation Layer, monitoring system.Design of Experiment (DoE).Data Analysis and Critical Parameters Monitoring.Process Parameters Definition: NOR (Normal Operative Range), PAR (ProvenAcceptable Range), Set Point, Process Ranges – Recipes implementation

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  Patheon

  May 2016 - Jun 2016

  QA/QC, Altran Consultant

  Data integrity.Audit trail Review

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  Zambon

  Jul 2016 - Aug 2016

  QA, Altran Consultant

  Investigation management: track and manage a broad range of deviations;root cause analysis, execution of corrective and preventive actions (CAPAs), and effectiveness analysis (Trackwise System).

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  AbbVie

  Aug 2016 - May 2018

  QA Validation

  Design Qualification (DQ);Installation Qualification (IQ) of pharmaceutical equipment;Operational Qualification (OQ) of pharmaceutical equipment;Performance Qualification (PQ) of pharmaceutical equipment;Risk Analysis for pharmaceutical manufacturing process;Failure Mode Effects Analysis (FMEA), Preliminary Hazard Analysis (PHA);Validation Master Plan (VMP);AIFA Notification;Periodic Validation Review (equipment/cleaning PVR);Validation Master Plan (VMP);Spruce Project: Support to the implementation of highly automated packaging (combined products) lines;Comissioning and Qualification approach: leverage on Supplier’s testing activities (FAT and SAT: Factory and Site Acceptance Test) to eliminate further IOQ testing. Review of Equipment and Process Requirements, Specifications and Test Protocols. Verification of Equipment Critical Elements (CE) and Critical Process Parameters (CPPs).Combination Products;Root cause analysis, execution of corrective and preventive actions (CAPAs). Show less

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  Thermo Fisher Scientific

  May 2018 - Mar 2022

  Technology Transfer Project Manager

  Management of technology transfer process of sterile pharmaceutical products:Feasibility analysis and execution of the transfer procedures performing risk analysis;Coordination of project progress, establishing relationship with the clients and project team;Management of project team;Identification and troubleshooting of the technical problems;Assistance to the effective startup of the production, in respect of the clients requirements, cGMP, internal quality requirements and business interests;Process design;Preparation of Engineering and clinical protocol, with the definition of CQA and CPP;Support the definition of new business opportunities;Coordination of initiatives related to a Technology transfer to minimize the production costs; Preparation of key documentation including the Technology Transfer Checklist, Project Gantt, Gap Analysis, Technology Transfer Master Plan/Scope, Technology Transfer Report, Project Timeline and Action Item lists;Provide support as needed to Validation and Production during the Validation/Stability phase, including review and approval of process validation documents.Support the Commercial Quotes Group ,with the evaluation of the technical costs of the new job orders, providing the material technical details, production schedule, processes, and supply costs, aligning with the interests of the company, in conjunction with EU central function. Show less

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  Johnson & Johnson

  Mar 2022 - Feb 2024

  EMEA LCM Project Manager

  End to End project management (technology transfer, business continuity, cost Improvement, compliance, regulatory);Project risks & issues management;Business case analysis coordinating cross functional team;Project reporting and communication to stakeholders at all levels of the organization;Supply Chain transformation management (stock build, phase in/ phase out);Project budget management: expenses budgeting, control & actualization, Savings & FTE budgeting, reporting, variance analysis;Communication of Project key aspects to all levels of the organization; Show less

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  Kenvue

  Feb 2024 - now

  EMEA E2E LCM Project Manager

  J&J spin-off Program Manager; Definition and negotiation of TMA (Transitional Manufacturing Agreement) in EMEA regionEnd to End project management (technology transfer, business continuity, cost Improvement, compliance, regulatory);Project risks & issues management. Due diligence;Business case analysis coordinating cross functional team;Project reporting and communication to stakeholders at all levels of the organization;Supply Chain transformation management (stock build, phase in/ phase out);Project budget management: expenses budgeting, Opex/CAPEX definition, control & actualization, Savings & FTE budgeting, reporting, variance analysis. Show less