Here, you’ll achieve greatness.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 duties 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
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, Anna Flister 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.
BioNTech - As unique as you