Scientist Analytical Development (m/f)

REFERENZNUMMER:

359914/11

IHRE AUFGABEN:

-Support the assignment and monitoring of work orders for Analytical Development of a selected project at external partners according to the respective project needs
-As a substitute CMC team member oversee the chosen project needs for Analytical Development activities and liaise internally with relevant interfaces to initiate, perform, and close these AD studies and prepare specifications and its justifications
-Outsource and conduct development, validation/transfer and application of analytical methods and supportive stability studies
-Supervise studies in cooperation with the Manager Stability & Release Analytics and develop appropriate conditions e.g. for forced degradation, in-use, or compatibility studies
-Organize and perform operation and maintenance of chosen equipment in the laboratory and train team members accordingly
-Keep external partners well-trained for the project needs, e.g. for correct peak assignment, sample handling and appropriate reporting
-Ensure acquisition of know-how and maintaining a profound expertise especially in analytical methodology, technology and regulatory guidelines
-Write analytical overview reports and support writing of development sections of regulatory documents

IHRE QUALIFIKATIONEN:

-Completed education in Chemistry, Pharmacy or equivalent
-Experience in development and outsourcing analytical methods and method validation
-Profound experience in Analytical Development or QC in the field of pharmaceutical development and/or analytical life cycle management
-Knowledge in chromatographic separation as well as in method development HPLC, IC, GC, Analytics
-Knowledge in Karl-Fischer analyses, method validation and experience in GMP, IC guidelines
-Very good English skills

WEITERE QUALIFIKATIONEN:

R&D scientist