Scientist Analytical Development (m/f)

REFERENZNUMMER:

282284/11

IHRE AUFGABEN:

-Supervision and support of analytical development work at CMOs
-Responsibility for an appropriate development of analytical methods to collect all the necessary data for a successful development at external partners
-Preparation of specifications for raw materials, in-process-controls, intermediates and final APIs
-Supervision of stability studies performed at CMOs
-Collection, interpretation and documentation of necessary analytical data for submission to health authorities
-Preparation of regulatory base documents for submission to the health authorities
-Transfer of analytical methods to internal and external partners
-Close collaboration with colleagues from Process Research & Development and from the Supply Center
-Participation in project teams and interdisciplinary collaboration with international teams from various functions

IHRE QUALIFIKATIONEN:

-In-depth education in analytical or organic chemistry, preferably to PhD level
-Profound experience in pharmaceutical development
-Experience in drawing up regulatory documents for IND/NDA submissions
-Preferably experience in collaborating with external partners
-Experience in working in a performance-oriented environment
-A very good command of verbal and written English and the willingness to learn German

WEITERE QUALIFIKATIONEN:

R&D scientist