Marcell Louis Email & Phone Number

Bergisch Gladbach, North Rhine-Westphalia, De

Project Manager in Pharmaceutical Development of Generic CNS Drugs- international project management of pharmaceutical development processes for generic and hybrid drug development with our contract developers and contract manufacturers (CDOs, CMOs), laboratories and clinical research organisations for bioequivalence studies.- mediation of project activities between all involved parties, externally as well as internal departments; regular reports to the 3rd Party Development Director and the Corporate Development Director - supervision of all associated drug quality (CMC) development stages: drug substance, early drug product development, analytical methods, final product (FDF) control, stability studies, further studies according to ICH and EMA guidelines, process development and validation, manufacturing, monitoring during the regulatory procedures up to the launch- evaluation and approval of associated regulatory and GMP documents according to quality criteria- compilation and scientific writing of dossier documents in the Quality Module; writing of deficiency letter responses- international communication with developers, manufacturers, laboratories and authorities; international business trips- budget preparation project costs, budget control