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Summary

For more than thirteen years I have been working in the pharmaceutical industry, in FDA approved sites, covering roles of increasing responsibility in the Quality, Manufacturing and New Product Introduction area. My experience is still growing within my domain. In a dynamic environment such as the pharmaceutical sector, I have improved and consolidated my technical knowledge and increased my managerial skills, switching from functional to matrix structures and multi-disciplinary teams either in mechanical or organic fields. I have matured within my leadership roles thanks to direct and indirect coordination of different teams throughout my professional experiences. I am strong with GMP, on aseptic environments and on the manufacturing operations management. I'm comfortable in multicultural and multinational environments, dealing daily with foreign customers. Solid knowledge of Project Management, applied to the technological transfer of new products including also the ability to perform budget forecast and cost estimates. Proven capabilities of Change Management, aimed at continuous improvement of processes in order to make them more efficient and obtain as a final result products with high quality standards. I have an excellent predisposition to changes and the tougher challenge that often I have to face it is not dealing with a new approach but the resistances that could be generated from it. I have learnt from experience that changing the mindset in a stable environment is not a trivial matter. I'm always open to new challenges and each new experience is a valuable opportunity to learn and continue to evolve professionally.

Experiences

Current Experience

  • New Product Introduction - Manufacturing
    Since September 2014
    In charge of the management of technological transfer in aseptic area, relating to the introduction of sterile oncology products, both liquid and lyophilized, handling the transfer process from the feasibility study to the product release; Close cooperation with the Business Development Manager in relation to budgeting and cost controlling of each project; Main point of contact for our clients, namely large international pharmaceutical groups; During the planning, the execution and the packaging of new products, I manage the manufacturing area and the staff, coordinating activities of the department head, supervisors and workers; Reviewing all the documentation related to the technological transfer, from user requirements for new equipment to the documentation for the manufacture of the new product. Cooperation with the QA Manager in troubleshooting activities related to critical deviations occurring during the manufacturing. In case of complicated deviation during the project and/or process activities, I am in charge of creating and managing an “ad-hoc” team with the scope to improve system and/or manufacturing processes. I am an expert of change management. One of the most important change carried out, has involved the introduction of disposable tools in the aseptic area. The result was an improvement that led to a reduction of production costs and time.

Past Experience

  • Sterile Cephalosporin Department Head
    January 2012 --- August 2014
    As department head, I managed the department having 6 supervisors, 1 Technical Support and 55 operators in order to coordinate the filling of sterile powders in vials and related secondary packaging; Involved in the preparation of the annual budget, and reviewing periodically of the costs and of the “bill of materials”, considering labor and equipment pool; Definition of the production plan; Involved in the introduction of new products with technical support during the scale-up in the plant; Management and implementation of the yearly department's training program; Review and approval of the department's MBR and SOPs; In charge for the management of the activities inherent the continuous improvement, focusing on OEE (Overall Equipment Effectiveness) of manufacturing lines and Packaging; Supporting the QA department during the investigation of deviations or complaints, and for the implementation of CAPA; Supporting the Manager area during Regulatory Audits (FDA, Anvisa and AIFA), SHE and customer Audits; Change Management (Creation of polyvalent operators).

  • Oral Cephalosporin Department Head
    January 2011 --- December 2011
    Leads a team of 2 supervisors, 1 technical supports and 30 operators. Responsible to reach the quality goals on the finished product, cost containment and productivity. Solid tabletting, compacting, powder filling and packaging (beta-lactam) Definition of the expenses to carry out the production plans, staffing and supplies; Authorities inspections. Manages the new products introduction and scale up.

  • Validation Supervisor
    June 2010 --- December 2010

  • QA Specialist & Change Control Coordinator
    July 2008 --- May 2010

  • Validation Specialist
    July 2006 --- June 2008

  • Vendor Qualification & GMP Auditor
    January 2004 --- June 2006

  • Technical-Support Junior Specialist
    May 2003 --- December 2003

Personality

Self Assessment :
OptimismAdaptabilityCommunicativeCollaborationAssertivenessStrategic thinkingResult OrientedResiliencyProblem solvingProactivityOrganization

Knowledge

LinkedIn Assessment :
GMPValidationQuality AssurancecGMPProblem SolvingManufacturingProcess ValidationPharmaceuticalsQuality SystemsAuditingChange ManagementComplianceProcess developmentSOPChange ControlTeam LeadershipEnglishMicrosoft OfficeWordQuality ManagementExcelAccessDocument ManagementPowerPointRisk ManagementBusiness AnalysisDocumentationProduction ManagementProcess improvementProduct developmentPharmaceutical IndustryAseptic ProcessingGXP21 CFR Part 11FDACAPARegulatory affairsGLPTechnology transferTrackwiseQuality AuditingGAMPFDA GMPChange ControlmanagementPharmaceuticsLife SciencesBiotechnologyR&DMedical Devices

Skills and Expertise

Self Assessment :
Work cross-functionallyassess the needs of the project(s)/program(s) and make changes in process, work flow and/or assignments.Manage complexityManufacture of GMP batchesManage aseptic riskManage projects resourcesNegotiate budget NegotiationAseptic techniquesAseptic processingDevelop business planDetermine potential relationshipsFollow up projectsFollow-up of external auditsFollow-up of quality assurance activitiesFollow-up of Quality Management System (QMS) processesForecasting of drug productForecasting of packaging workloadFollow up training programsFollow-up of internal auditsGeneral office managementIdentify and provide training to trial team and associated staffImplement ProcessesImplement Quality Management System (QMS)Lead teamsMaintain Quality Management System (QMS)Maintain strong relationshipsManage budgetsManage contractors Manage data collection systemManage data reporting systemsManage front deskManage multiple projectsManage Quality Management System (QMS) documentationManage risksMonitor Key Performance Indicators (KPI's)NetworkNon-aseptic processingOffice managementOral presentationPeople managementPrepare external auditsPrepare internal auditsPrepare investigator brochuresproject managementProtocol managementProvide support for scientific and/or technical projectsProvide technical supportReport Key Performance Indicators (KPI's)Report non-compliance incidentsSite management

Education

  • Master in Project Management in Project Management from MIP-Politecnico Di Milano in 2016
  • Bachelor in Pharmaceutical Chemestry from Università degli Studi di Siena in 2002

Training and Certification

  • “Certified Project Management Associate – IPMA Level D®” Certification
  • Six Sigma Certification - Six Sigma Green Belt Certification

Languages

BrightOwl Assessment:
Self Assessment:
Italian
Native
English
Full Proficiency

Work Preferences

  • Notice Period:
    7 weeks
  • Positions I am interested in:
    Business Development Manager Operations Manager CMC Manager CMC Project Manager Compliance Manager General Manager Managing Director Management Consultant Production Manager Program Manager (PMP & CSM) Project Manager QA Consultant QC/QA Manager Quality Assurance (QA) Manager Quality manager Senior Consultant Senior Project Manager (PM) Business Consultant Chief Strategy Officer Clinical Project Manager (CPM) Field Project Manager Global Clinical Project Manager (GCPM, GTM) Global PM
  • Work From Home:
    No
  • International:
    Yes

Publications

    Expert has 1 publications (Will be avalible with full profile)

Area / Region

Latina, Province of Latina, Italy

Others

Driving License
  • Yes