CMC mAB Specialist

CMC mAB Specialist

BioNTech

Mainz, Germany

Here, you’ll achieve greatness

At BioNTech, you will lead manufacturing of monoclonal antibodies (mAB) for BioNTech´s clinical trials. You will make strategic decisions that ensure product quality and supply of therapeutics. Furthermore, you will compile the CMC content for the regulatory documents. In your role, you will act globally and work cross-functionally.

Your duties in detail:

  • Support in definition and conduct of CMC development strategy of all BioNTech´s mAB products from FIH to launch;
  • Planning and supervision of manufacturing of mAB for clinical trials inclusive main point of contact for CMOs and CTOs;
  • Compilation of CMC content for regulatory documents of mAB in clinical development phases incl. active role in consultations of agencies;
  • Planning and coordination of process validation and compilation of BLA and MAA;
  • Support in contracting of CMOs, CTOs and quality assurance measures;
  • Participation in internal and external cross-disciplinary teams as responsible person for mAB CMC aspects.

What you have to offer

  • Degree in pharmacy, chemistry, biology, biochemistry, or equivalent;
  • 5 years professional working experience in manufacturing of mAB in the development (preferable both USP and DSP);
  • 2 years professional working experience in CMC Regulatory Affairs in the development of biologics;
  • Knowledge of drug development (Drug Substance and Drug Product) and knowledge of multidisciplinary functions involved in drug development, manufacturing and commercialization;
  • Result-and goal-oriented;
  • Excellent communication skills in English, preferably also in German.

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© EuroJobsites 2019

EuroJobsites is a UK registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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