• Jobs Job bei BioNTech SE

Natural Scientist - Project Management, CMC for mAB (m/w/d)

BioNTech SE

Mainz, 55131


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Everyone can achieve great things at BioNTech We develop revolutionary approaches in the fight against cancer and other diseases. BioNTech wants to become the world´s leading biotechnology company for individualized cancer medicine. Over 1000 dedicated, passionate pioneers achieve sensational success and promising breakthroughs time and again by forging new paths - and ensure people all around the world have hope for the future. You too can become a pioneer Senior Project Manager Manufacturing / CMC for mAB At BioNTech, you will coordinate all aspects of manufacturing of monoclonal antibodies (mAB) for clinical trials from cell line development of FillundFinish. You will prepare strategic decisions that ensure product quality and supply of therapeutics. Furthermore, you will support the compilation of CMC regulatory documents. In your role, you will act globally and work cross-functionally. Your duties in detail: Planning and supervision of manufacturing of mAB for clinical trials inclsive main point of contact for CMOs and CTOs Planning and coordination of process validation and compilation of BLA and MAA Participation in internal and external cross-disciplinary teams as responsible person for mAB CMC aspects Support in definition and conduct of CMC development strategy of all BioNTech´s mAB products from FIH to launch Support up to Compilation of CMC content for regulatory documents of mAB in clinical development phases Support in contracting of CMOs, CTOs and quality assurance measures Degree in pharmacy, chemistry, biology, biochemistry, or equivalent Several years of professional working experience in manufacturing of mAB in the development (preferable both USP and DSP) Knowledge of drug development (Drug Substance and Drug Product) and knowledge of multidisciplinary functions involved in drug development and manufacturing Result- and goal-oriented Excellent communication skills in English Jobticket Child Care Company Bike Fitness Pension Relocation and much more.


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