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
Here, you’ll achieve greatness.At BioNTech, you will coordinate all aspects of manufacturing of monoclonal antibodies (mAB) for clinical trials from cell line development of Fill&Finish. 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 inclusive 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
What you have to offer.
- 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
Benefits for you.
Have we kindled your pioneering spirit?Then apply now for our location Mainz and simply send us your application documents using our online form.
If you have any further questions, Friederike Mangelsen will be happy to answer them on + 49 (0) 6131-9084-1291 (monday-friday, from 12 noon).
*BioNTech does not differentiate on the basis of gender, race, religion, color, origin, sexual orientation, disability, age and other protected status as required by applicable law. We are committed to creating a diverse environment and are proud to be an equal opportunity employer.
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