(Senior) CMC Expert* Asia

  • Mainz
  • Work experience
  • Project Management, Product Management
  • Research, development, teaching
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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.

(Senior) CMC Expert* Asia

At BioNTech you will be responsible for the CMC aspects of our collaborations in the Asian/Pacific area, incl. the transfer and establishment of complex pharmaceutical process and their validation, the support of regulatory filings and the interaction with local regulatory agencies. Your main responsibilities are:
  • Develop detailed CMC project plans related to our Asian cooperations in collaboration with technical leads and expertise areas (e.g. Process/Analytical Development, Quality, Regulatory, Supply Chain, Operations, Commercial)
  • Ensure alignment with global strategic and operational functions within the organization
  • Lead the scientific/technical assessment of development programs related to all CMC aspects 
  • 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 function in a pharmaceutical environment, a good understanding of pharmaceutical regulations in Asia is requiered. Sound knowledge of GMP and ICH requirements for manufacturing and analytics. Documented experience in relevant CMC regulatory affairs would be a plus
  • Solid CMC development understanding of 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; Experience defining and executing strategy is required
  • Asian language skills (written and spoken) would be a plus

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