Dr. Michael Lambert

GMP surveillance responsible for Europe incl. - GMP Audits for API-, FDF- and Contract Manufacturers, - corporate self inspections, - customer, certification and authority inspections - international project management regarding QM and GMP topics Deviation and complaint management, CAPA and Change Control. Continous improvement of global corporate quality management system. Deputy director of Midas Quality unit.

Planning&installation of R&D lab and large scale upstream/fermentation plant (risk levels S2/L2) for hAPIs according to GMP standards within the Business Unit Pharmaceutical Ingredients. Manufacturing of hAPIs for chemotherapy using genetically modified organisms (GMO). Development, scale-up and optimization of manufacturing processes. Functions of a head of production AMWHV, Qualified Person (QP) AMG, Project Manager/Authorized Person for Biological Safety GenTSV.

Planning&Installation of a R&D lab and a production/fermentation plant (risk level S1/L2) for Bioreagents within product sector Rapid Tests. Development & production of (i) toxicity tests /e. g. luminous bacteria, nitrification inhibition test), (ii) IVD 8e. g. test stripes for indole, oxidase, blood and DNA conservation) (iiI) photometric rapid tests (e. g. BOD5, pesticides, methanol, ethanol). Member of various DIN working groups.

Biotechnololgy; Fermentation of fungi; Biological degradation of PAHs; Separation, isolation and identification of pyren-metabolites

Microbiology, Biotechnology, Biochemistry; 04/1990 - 12/1990: Diploma thesis at the Local Academy and Research Institute for Agriculture, Viniculture and Horticulture in Neustadt/Weinstraße, Department of Phytomedicine (Head Prof. dr. Klaus W. Eichhorn)