Project Manager* CMC

  • Mainz
  • Work experience
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Become a member of the BioNTech Family!

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.

Project Manager* CMC

At BioNTech, you will be part of our CMC Project Management team, supporting clinical projects from early to late development stages. Your responsibilities in detail:
  • 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
  • Childcare
  • Jobticket
  • Company Bike
  • Leave Account
  • Fitness Courses
  • Mobile Office
  • Special Vacation
... and much more.

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, 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, 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

https://biontech.de