Claudia Picker (ex. Marker)

Coordinate all launches owned by the Plasma OpU. Keep overview of all Plasma OpU launches and ongoing programs. Assure communication with the Plasma OpU supply chain team. Establish and lead the supply launch team, auch as LOCs, Regional Supply Chain, Regularly, Site Supply Chain, etc. to assure a timely and flawless launch. Establish launch timeline/milestone to achieve the trade stock available date and execute launch with SLT. Monthly KPI reporting. Communicate the status of launches. Own ChangeControls

Enable consistent and efficient global clinical supply chain by defining strategies for IMP and ancillary labeling, packaging, distribution, storage, testing, returns & destruction. Oversee Clinical Supplies Project Manager activities and manage trouble shoots. Ensure continuation and enhancement of supply to address shortfalls and develop strong partnerships with key stakeholders, to facilitate an outstanding global clinical supply chain for patients.

Guide operational teams and proposal writing team, providing hands-on guidance and direction in the execution of daily operations. Manage staff and simplify supply at program level, to reduce cost and increase flexibility of supply for Phase I-IV global clinical studies. Increase profits by assessment of subcontractor prices and strategic supplier selection. Negotiate contracts with service providers, implementing strategies to strengthen customer loyalty and satisfaction.

- Team leader - Project strategy set-up, -coordination/management - Oversight on project budget - Proposal compilation CL-services: data collection to establish realistic & reliable cost estimations, close communication with sponsor & sub-contractors, evaluation of feasibility, frequent assessment of subcontractor prices - Evaluation & selection of sub-contractors - Control of incoming accounting's of sub-contractors - SOP writing - Provide staff training of quality control-specific processes

- Erarbeitung einer LC/MS-MS-Methode - Validierung der Methode nach CD 2002/657/EG - Erarbeitung einer Extraktionsmethode für Harn- und Leberprobenmaterial - Extraktreinigungen mittels Festphasenextraktion - Mitwirkung bei der Erstellung von Prüfvorschriften - Einschulung von Kollegen

Biochemie und Genetik

Biomedizin, Genetik