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.
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