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Scientific Associate Director; Impurities & Registrations

Stephanie Simon

471
31
4
Mon - FriAvailable working days

Professional Summary

I’m a molecular biologist by training and received my PhD (Dr. rer. nat.) from the University of Heidelberg. In addition, I’m a EUROTOX certified toxicologist and have excellent skills in safety testing according to national and international requirements. My current role within the Chemicals Toxicology group includes toxicological (risk) assessments for impurities and excipients as well as derivation of health-based exposure limits for workplace safety, production or patients. I’ve led the Genetic Toxicology laboratory at Merck for more than six years and have more than 19 years of experience in toxicology. My responsibilities included support of pharma and chemistry projects as GLP study director, monitor and toxicology expert. I’m a recognized expert in the field of Genetic Toxicology within the company and the scientific community. Additionally, I’m active in the Health and Environmental Sciences Institute, Genetic Toxicology Technical Committee (HESI GTTC) and I’ve organized the German Industrial Genetic Toxicology Group for several years. During a six month’s secondment for professional development in the US, I gained considerable management and leadership experience in an international environment. As member of the Test Facility Management Team, I actively contributed to an FDA/OECD audit. My highly professional working attitude, exemplary organizational and collaboration skills and my impartiality were key for working under high pressure in a multi-cultural environment in one of the largest Contract Research Organizations for Genetic Toxicology.

Skills

Nitrosamines
Genetic Toxicology
Mutagenicity Testing
Impurities
Preclinical Safety
Chemical Safety

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