Dipl.-Ing. Stefanie Van Wynsberghe

Angestellt, Manager, External Technical Oversight, F. Hoffman-La Roche Ltd.
Steinen, Deutschland

Fähigkeiten und Kenntnisse

Technical Transfer
Development
Commercialization
Strategic Sourcing
Supply Chain Management
Trouble-Shooting
cGMP Manufacturing
Regulatory Compliance
Process Improvement
Validation
Project Management
Change Management

Werdegang

Berufserfahrung von Stefanie Van Wynsberghe

  • Bis heute 6 Jahre und 2 Monate, seit Juni 2019

    Manager, External Technical Oversight

    F. Hoffman-La Roche Ltd.

  • 1 Jahr und 1 Monat, Mai 2018 - Mai 2019

    Project Team Lead for Chemicals & Anti-Infectives

    Novartis Pharma AG

  • 5 Jahre und 5 Monate, Juni 2012 - Okt. 2017

    Technical Project Manager, Chemical Development & Manufacturing / Outsourcing

    Gilead Sciences, Inc.

    Managed supply chain from raw materials to API for developmental and commercial projects. Maintained business and technical relationship with CMOs throughout project/product life cycle. Supported regulatory filing activities. Participated in on-site quality audits for API and GMP intermediate manufacturing. Associate Manager 01/2017 - 10/2017; Senior Associate 01/2015 - 12/2016; Associate II 01/2013 - 12/2014; Manufacturing Associate 06/2012 - 12/2012

  • 4 Jahre und 6 Monate, Dez. 2007 - Mai 2012

    Process Chemist, Process Research & Development

    Gilead Sciences, Inc.

    Developed, optimized and scaled-up chemical reactions, isolations, separations, purifications and crystallizations for various intermediates and drug substances. Supported technical transfer activities to in-house and external manufacturing sites. Monitored reactions, assessed purity, and evaluated process safety. Prepared non-GMP and GMP batch records for in-house manufacturing and reviewed batch records for outsourced activities. Used DOE to support process development and stress testing.

  • 3 Monate, Okt. 2007 - Dez. 2007

    Research Associate

    Cytokinetics

    Managed and maintained sample bank inventory, and prepared biological assays with automated systems.

  • 1 Jahr und 1 Monat, Aug. 2006 - Aug. 2007

    Process Chemist, Pharmaceutical Sciences

    Pfizer, Inc.

    Optimized and scaled-up chemical reactions from 100-mL to 20-L reactors. Analyzed and monitored chemical reaction processes. Developed and optimized processes for 2 intermediates and 1 drug substance.

  • 1 Jahr und 4 Monate, März 2005 - Juni 2006

    Materials Engineer

    Delphi Thermal & Interior

    Researched and compared material data, material specifications, test methods and supplier specifications for automotive components. Initiated cost modeling projects and benchmarking activities.

  • 7 Monate, Okt. 2003 - Apr. 2004

    Thesis Student, School of Engineering Science

    Murdoch University

    Designed a batch biodiesel pilot plant in partial fulfillment of the engineering degree requirement. Under scholarship from the State of Baden-Württemberg.

  • 7 Monate, Aug. 2002 - Feb. 2003

    Engineering Intern, Technical Research and Development

    Novartis Pharma AG

    Engineering Intern, Technical Research and Development

  • 6 Monate, März 2001 - Aug. 2001

    Engineering Intern, Research and Development

    Fresenius Medical Care AG

    Engineering Intern, Research and Development

Ausbildung von Stefanie Van Wynsberghe

  • 2 Jahre und 1 Monat, Aug. 2010 - Aug. 2012

    Ageno School of Business at Golden Gate University

  • 3 Jahre und 10 Monate, Okt. 2000 - Juli 2004

    Verfahrenstechnik

    Fachhochschule Furtwangen

    Biologische Verfahrenstechnik

  • 1 Jahr, Okt. 1999 - Sep. 2000

    Biologie

    Universität Basel

    Two semesters towards a Diplom in Biology

Sprachen

  • Deutsch

    Muttersprache

  • Englisch

    Fließend

  • Französisch

    Grundlagen

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