CMC Manager*

  • Mainz
  • Production, manufacturing
  • Research, development, teaching
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Become a member of the BioNTech Family!

As a part of our team of more than 2.500 pioneers, you will play a key role in developing solutions for some of the most crucial scientific challenges of our age. Within less than a year, we were able to develop our COVID-19 mRNA vaccine following the highest scientific and ethical standards – writing medical history.
 
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*

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) in close collaboration with other technical teams and the regulatory affairs team
  • Communication with CMOs and analytical laboratories for GMP manufacturing and quality control for supply of clinical studies 

What you have to offer.

  • PhD in life sciences or Masters level education with significant CMC experience in the pharmaceutical industry
  • Good knowledge of GMP and CMC considerations related to the manufacture of pharmaceutical products
  • Working experience in CMC/GMP management or Project/Program management
  • Knowledge of formulation and production processes relating to pharmaceutical development (preference for specific knowledge of colloidal systems, drug delivery, nanoparticle preparations and/or RNA or DNA-based products) 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.

  • 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, our Talent Acquisition Team will be happy to answer them
on + 49 (0) 6131-9084-1291  (monday-friday, from 12 noon to 4 pm).

Job-ID 1929 (please indicate for inquiries)

We look forward to your application!


*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

https://biontech.de