Dr. Jana Fischer
Angestellt, External Site Operations Lead, Associate Director, Takeda
München, Deutschland
Werdegang
Berufserfahrung von Jana Fischer
Bis heute 8 Jahre und 9 Monate, seit Okt. 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 manage with the CMO
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 Jahre und 10 Monate, 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 Jahre und 6 Monate, 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
Englisch
Fließend
Deutsch
Muttersprache