CMC Manager*
BioNTech
Mainz
vor 4 Tg.

As a part of our team of more than 1.500 pioneers, you will play a key role in developing solutions for some of the most crucial scientific challenges of our age : Amongst multiple programs in the pipeline, we are conducting research on a Covid-19 vaccine in our project Lightspeed based on our mRNA-technologies.

Furthermore, we are pioneers in the development of individualized cancer therapies and in the combat against other diseases.

We aim to achieve life-changing successes for patients by being innovative, passionate and united,so get in touch with us if you are looking to be a part of creating hope for a healthy future in many people s lives.

CMC Manager*

At BioNTech, you will be part of our GMP and CMC management team supporting all clinical projects with respect to product quality and CMC documentation for regulatory dossiers.

Your responsibilities in detail :

  • Management of CMC operational activities e.g. assessment of critical quality attributes, critical process parameters, in-process controls, process validation, starting material and drug product quality and characterization, reference standards, stability studies etc.
  • Coordination of development tasks towards collection of required information and contribution to respective documents (e.
  • g. risk analysis, briefing books, IND, IMPD, study plans and reports, etc.) in close collaboration with other technical teams and the regulatory affairs team

  • Communication with CMOs and analytical laboratories for GMP manufacturing and qualtiy control for supply of clinical studies
  • What you have to offer.

  • Degree in chemistry, biotechnology, biology, pharmacy or an analogous field, ideally with a PhD
  • Several years of working experience in GMP / CMC management
  • Very good knowledge in GMP, pharmaceutical technology, production processes for pharmaceutical products to be administered parenterally, and / or nanoparticle preparations
  • Ideally first experience in supporting the transfer of products from development to market
  • Very good communication skills including very good German and / or English language skills and excellent organization and presentation skills
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