Dr. Michael Klein

Qualifizierungen von Produktionsanlagen Reinigungs-und Prozessvalidierungen Erstellung von Risikoanalysen Erstellung und Prüfung von SOPs, Qualifizierungs-/Validierungs-Plänen, Protokollen und Berichte Präsentation bei nationalen und internationalen Behördeninspektionen und in Kundenaudits Annual Product Reviews Mitarbeit im GMP-konformen Abweichungs-, Änderungs-, OOS- und Datenintegritäts- Managements Datenintegritätsbeauftragter Strahlenschutzbeauftragter Laserschutzbeauftragter

Using the skills and experience described in the previous role to implement the system on a start-up company Leading team of two synthetic chemist, co-ordinate work with analytical chemist Process development and optimisation of API’s under GMP Building up lab structure Support of Quality control and Quality assurance Laser safety officer

Development of strategies for the synthesis of vitamin K (MK7) and testing of them. Organisation and maintenance of the laboratory Manufacture of vitamin K (MK7) using a new developed synthesis on a multigram scale. Envisioned of the synthetic route, realisation of the corresponding experiments including scale up to a multi gram scale (18 steps over all).

Participant of the interdisciplinary, multinational EU-funded QUASI-Project (Quantifying Signal Transduction) as synthetic chemist Design of kinase-inhibitors in collaboration with modelling experts Development of synthetic strategies and synthesis of kinase inhibitors using medicinal chemistry principles Supervisor for Masters and Ph.D. students including international exchange students.

Synthesis, Structure and Properties of Functionalised, Cyclic Enediynes and Examination of Electronic Substitution Effects on the Bergman Cyclisation of Acyclic Enediynes