GMP Manager
GMP Manager
BioNTech
Mainz, Germany
At BioNTech, you will be part of our GMP and CMC management team supporting all clinical projects with respect to CMO and supplier management.
Your responsibilities in detail:
- Exploration and supervision of external contract manufacturers for the production of products for pharmaceutical use (e.g. liposomes, RNA nanoparticle formulations, excipients)
- Coordination of internal and external development work towards production of RNA pharmaceutical products in compliance with GMP
- Support compilation of documents relevant for clinical development, e.g. study reports, SOPs, PSFs INDs, IMPDs
- Responsibility for the development of technologies for GMP-compliant production processes (upscaling) from investigational clinical products to market supply
- Explore new technologies for the production of liposomes and RNA nanoparticle preparations
What you have to offer
- Degree in chemistry, biotechnology, pharmacy or an analogous field, ideally with a PhD
- Profound knowledge of scientific and technological aspects in connection with colloidal systems, drug delivery, gene delivery and/or RNA or DNA-based products
- Good understanding of technological and physical interrelationships with regard to pharmaceutical manufacturing
- First working experience in a GMP regulated environment is desirable
- Very good communication skills. Very good English language skills
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