Juergen Keller Email & Phone Number

Sulgen, Thurgau, Schweiz

Schaffhausen, Schweiz

•Leadership, coaching and development of a team with up to four team members•Development, expansion and organization of the General Analytical laboratory in accordance with GMP-, LEAN- and safety requirements•Responsible of analysis for clinical phases, method-development and -validation as well as R&D analysis for raw materials, intermediates and APIs, analytical investigations for production, post approval support and troubleshooting•Organization and implementation of maintenance of analytical equipment, documentation in SAP/R3 and GMP qualification according to pharmacopöe requirements (EP, USP, JP, PPRC)•Extend analytical support by implementing new technologies:Microscopy, particlesize determination by means of laser diffraction, Ionchromatography, Density-, Melting Point- and Refractive Index determinations, NIR, Polarography•Review and editing of SOPs•Recording, editing and approval of deviations and change controls in Trackwise system•Performing of Morphology-, Zetasizer- and Osmolarity-measurements using external laboratory devices•Perform stability analyses for intermediates and APIs in development phases•Analytical project management for preclinical and early clinical phases (2004-2008):Coordination and support of analytical development for raw materials, intermediates and APIs, control of release analytics, production and provision of analytical documents, specification definition in cooperation with R&D laboratories•Responsible for work preparation (2004-2013):Order management, sample management and document archiving

Schaffhausen, Schweiz

Validation of chromatographic and non-chromatographic methods:HPLC, GC, GS-HS, TLC, potentiometric and visual titration, volumetric and coulometric Karl-Fischer-determination, residue on ignition, loss on drying and heavy metal according USP/EP, UV/VIS-assay determination.

Dielsdorf, Zürich, Schweiz

Professional support of analysts, review of analytical results and requests and creation of validation reports

Dielsdorf, Zürich, Schweiz

Release analysis and method validation of chromatographic and non-chromatographic methods, responsible for maintenance and qualification of laboratory equipment

Freiburg I.Br.

Microbiological and chemistry quality control of drinking water, surface water and swimming pool water.