Estelle Pietrolungo

Product testing for commercial and development, including routine testing, tech transfers, co-validations, audits, compliance, qualification of new equipment.

Deployment of the Global Operational Excellence roadmap in 3 main Manufacturing sites: Aubonne, Darmstadt & Vevey: Management of the local GOE teams to deliver on respective site roadmaps, deployment of a local GOE programs aligned with the GOE standards, Site Directors and site GOE coaching, Trainer for Lean & Six Sigma, project management, site reporting.

Creation of a web platform interfaced with SharePoint and dedicated to the EHS community: EHS Excellence Handbook and Cultural EHS initiative (Vevey): Health & Well Being program; upscale of EHS Global Team with OE trainings (RACI workshops, Gembas, …).

* Full time Black Belt position: * Coordination of TURBO program and site road map to increase site Performance Management, Fishbone, House of Operations and Best Practice Sharing programs * Set up of Standard Time Program: Definition and Continuous Improvement, Visual management... * Coordination of Operational Readiness tool for Large Scale Biotech project integration * Lean & Six Sigma projects: * Top Employer Environment program (3rd raking place in Bilan survey), Implementation of new time & absence management system (Bixi systems) and payment system (Polyright), Lead time reduction for Drug Substance release, Implementation of Sustainable development program, 5S in production, ... * Other initiatives: * Merck Millipore In Sourcing, Site marketing concept for Contract Bio Partnering, Implementation of HR benchmarking program, Infrastructure project: Renovation for site Day Care nursery, Global approach for soft business...

Full time Black Belt position to lead Lean Six Sigma improvement projects. In charge of Fishbone improvement program at MSBC

* Compliance activities: * In charge of DSP1 release ( batch records control, deviations, investigations related to Bulks, CCPs, ...), internal audits, and annual product reviews for Rebif G1 and G2 SFM. * Black Belt activities: * First Lean Six Sigma project started in September 2008: Set up time reduction in Manufacturing Technical Support lab

ACAMBIS, Inc (Cambridge, MA, USA): Six month internship in Research Laboratory directed by Dr Thomas Monath, Immunology and Cell Biology Department. Subject: Research concerning the T-cell response of human subjects in Clinical Trials of ChimeriVax™-Dengue1-4 and ChimeriVax™-West Nile Vaccines; In vitro tests of IFN-gamma, IFN-alpha human cytokine responses to vaccine using sera or cell culture of peripheral blood mononuclear cells; comparison of different multiplex methods to quantify cytokines in human serum as indicators of host antiviral activity: ELISA Assays, Flow Cytometric Bead Array Assay (BD Biosciences), Cytokine Protein Microarray (Fast Quant, Schleicher & Schuell), Use of Microassay software to create standard curves and calculate data (Softmax, Array Vision, XL System II). Bibliographic research concerning Cytokines and Flavivirus.

Supervise a team around 20 people in manufacturing purification unit. Initially as a technician and then supervisor in purification of recombinant IFN-b REBIF® lab at an industrial scale: different types of Ultrafiltrations, Chromatographies as ion-exchange, size exclusion, HPLC, training of other operators. In charge of Annual periodic reviews, auditing, compliance, batch records control, deviations, investigations, procedures writing.

Site architect of Vevey site for BOOST program: OE transformation combining management of Lean & Sigma projects as well as the introduction of soft concepts as vision definition, change management, feedback and problem solving culture, coaching. This includes the implementation of roadmap and performance management cascades (dashboards & daily meetings)

2003: INSERM U464, Laboratory of Ion Channels Neurobiology (Marseille, FRANCE): 6-week internship as laboratory research assistant in neurobiology. Subject: Optimisation of a cell model for a Neurodegenerative Disease: Spinocerebellar Ataxia 6, Molecular Biology, Transformation of bacteria, DNA purification, Electrophoresis, Cell culture (PC12, rat neurones), Neurone Transfection by Lipofection, Confocal Microscopy. Activities and Societies: 2002/03: SANOFI PASTEUR (Lyon, FRANCE): 12-week internship followed by 9-week summer job in Quality Control, virologic control laboratory in P3 zone. Subject: Update according to OMS and European Pharmacopoeia recommendations: Optimisation and validation of the inactivation control technic and viral inactivation controls on rabies vaccines. Practical laboratory experience: Cell culture (VERO, MRC5, Vervet kidney cells), immunofluorescence, virus growing and titration, training in P3 zone.