CMC Expert* TechTransfer

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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.

CMC Expert* TechTransfer

At BioNTech you will be responsible for the transfer of complex manufacturing processes and analytics by providing strategic scientific input in the transfer programs regarding technical and regulatory aspects. Your main responsibilities are:
  • Lead the global transfer of complex manufacturing processes, pre- and/or post approval, in collaboration with technical leads and expertise areas (e.g. Pharmaceutical/Process/Analytical Development, Quality, Regulatory, Supply Chain, Commercial) 
  • Lead and support the scientific/technical assessment of development programs related to manufacturing efficacy and robustness as the CMC Transfer project lead
  • Manage CMC timelines and budget as well as risk management, incl. implementation of processes to identify risks, maintain risk registry and proactively execute mitigation plans 
  • Drive timely and data-driven decision making, and facilitate strategic discussions within CMC and with external partners as well as continuous improvement of process and data quality, through streamlining and optimizing processes, automation and digitalization

What you have to offer.

  • Degree (MS/PhD) in Pharmacy, Chemistry, Biopharmaceuticals, Biochemistry or Biology with professional experience in an international, pharmaceutical environment
  • Profound working experience in a leading quality function in a pharmaceutical environment as well as a sound knowledge of GMP and ICH requirements for techtransfer, documented experience in relevant CMC regulatory affairs would be a plus
  • Solid understanding of CMC development at all stages of drug development; experience with regulatory filings for biologicals (IND/IMPD, BLA/MAA) is considered a plus
  • Excellent communication and negotiation skills and ability to clearly and concisely communicate complex technical matters to senior management as well as experience in defining and executing strategies 

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