CMC Manager* RNA
- Work experience
Become a member of the BioNTech Family!
We aim to reduce the suffering of people with life-changing therapies by harnessing the potential of the immune system to develop novel therapies against cancer and infectious diseases. While doing so, we are guided by our three company values: united, innovative, passionate. 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* RNA
- Coordination of CMC operational activities for drug substance manufacturing across different units, e.g. process and analytical method development, assessment of critical quality attributes and critical process parameters, manufacturing
- Ensure the timely availability of information and contribution to required documents (e.g. risk analysis, briefing books, IND, IMPD, study plans and reports, etc.) in close collaboration with Technical and Regulatory Affairs teams
- Act as point of contact for CMOs and analytical laboratories for GMP manufacturing and quality control, to ensure the supply of drug substance for pre-clinical and clinical studies
- Ensure achieving the program’s CMC goals by planning and monitoring budget, time and quality, and execute mitigation plans if applicable
What you have to offer.
- Degree in Chemistry, Biotechnology, Biology, or an analogous field, ideally with a PhD
- Demonstrated, sound understanding of RNA technology and RNA production processes
- Several years of working experience in CMC and/or GMP environment
- Experience in project management
- Ideally first experience in supporting the transfer of products from R&D development to clinic
- Very good communication skills including very good German and/or English language skills as well as excellent organization and presentation skills
- Supportive interpersonal team player, talented at collaborating cross-functionally
Benefits for you.
- Company Pension Scheme
- Company Bike
- Leave Account
- Fitness Courses
- Mobile Office
- Special Vacation
Have we kindled your pioneering spirit?
If you have any further questions, Margarita Hoffmann 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 or ethnicity, religion, color, sexual orientation or identity, disability, age and other protected statuses as given by applicable law. We are committed to creating a diverse environment and are proud to be an equal opportunity employer. Most important – it’s a match!
BioNTech - As unique as you