Dr. Jana Fischer

Angestellt, External Site Operations Lead, Associate Director, Takeda
München, Germany

Fähigkeiten und Kenntnisse

Biotechnology
Contract Manufacturing Management
Herstellungsleitung
Due Diligence
Risk Management
Projektmanagement
Organische Synthese
Bioverfahrenstechnik
Drug Substance
Drug Product
Packaging
Finished Drug Product
Finished dosage form

Werdegang

Berufserfahrung von Jana Fischer

  • Current 10 years and 8 months, since Oct 2015

    External Site Operations Lead, Associate Director

    Takeda

    Virtual plant manager: - accountable and responsible for all manufacturing activities at a CMO - overall accountability for all aspects of performance at a CMO - lead the team that us mutually accountable for clinical & commercial product supply, new product introductions, technology transfer, CMO management and strategy - act as key account manager with the CMO

  • 1 year and 10 months, Dec 2013 - Sep 2015

    Global Project Manager

    Teva ratiopharm

    Control and coordinate international OTC development projects within PGT including in-house developments as well as development at external cooperation partners. Evaluate and push product innovations. Support selection of OTC products at the scientific and technical level (includes the definition of target product profiles). Participation in international due diligences for external development projects. Development and maintenance of appropriate project management tools.

  • 2 years and 10 months, Apr 2011 - Jan 2014

    Project Manager

    Sandoz GmbH

    Initiate, manage, and finalize internal and external projects for development within the BU Anti Infectives – improve efficiency and effectiveness of API development: Apply and manage multiple projects to ensure timelines, to monitor and meet budgets, and quality objectives. Coordinate and lead cross-functional global development project teams. Negotiate conditions and contracts with external development partners. Compile and report project status to senior management.

  • 3 years and 6 months, Nov 2007 - Apr 2011

    Regulatory Affairs Manager

    Sandoz GmbH

    Work in global project teams to ensure the timely introduction of new products to the market. Professional and timely processing of registration documents (intermediates and APIs). Local change manager: assessment of local change applications for intermediates and APIs. Preparation, assessment and approval of different SOPs. Processing of customer requests in cooperation with the technical competence centre (marketing and sales).

Ausbildung von Jana Fischer

  • 2003 - 2007

    Chemistry

    Leipzig

    Medicinal Chemistry

  • 1998 - 2003

    Chemistry

    Leipzig

    Organic Chemistry

Sprachen

  • English

    C1 (Fließend)

  • German

    C2 (Verhandlungssicher / Muttersprachlich)

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