Analytical Project Leader (m/f)

REFERENZNUMMER:

364848/11

IHRE AUFGABEN:

-Analytical Project Lead during development of small molecule NMEs throughout product launch
-Owner of the analytical control strategy, to be developed in collaboration with the technical teams
-Routine application of ICH-, and company-guidelines
-Collaboration with all relevant partners and stakeholders
-Collaboration with external partners, thereby accountability for method transfers, raw data review and appropriate documentation for health authority submissions
-Compilation of technical regulatory documents such as NDA and MAA (Module 3)

IHRE QUALIFIKATIONEN:

-PhD degree, preferably in chemistry, food chemistry, pharmaceutical sciences or related field
-Profound experience within analytical development for drug substance and/or drug
-Product in pharmaceutical industry
-Strong quality mindset with attention to detail, “can-do” work ethics
-Excellent knowledge about cGMP regulations and ICH guidelines
-Experienced in regulatory writing and with health authority interactions
-Excellent German and English verbal and written skills
-Excellent organizational, planning and communication skills
-Goal- and team-oriented mindset

WEITERE QUALIFIKATIONEN:

R&D scientist