Director* CMC

Become a member of the BioNTech Family!

As a part of our team of more than 4.000 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.


The Director CMC will play a key role by leading multiple complex scientific development projects from pre-clinical stage to post-marketing in the area of recombinant proteins and related products (eg ADCs). Being accountable for the programs, the Director CMC will together with the CMC-team be responsible for creating integrated CMC project plans, tracking progress, identifying and managing risks, and communicating across all levels of the organization. In the position as CMC-Subteam lead he/she will represent the CMC-team in the respective program team and will brigde the clinical projects with the drug substance and drug product development and analytical development work within the global organization. In collaboration with internal departments, the Director CMC will provide strategic scientific input in the development programs. In addition, and if applicable, the director will serve as the liaison and key contact for strategic Contract Development and Manufacturing Organization partners.


Your main responsibilities are:

  • Collaborate with technical leads and expertise areas (Process Development, Analytical Development, Quality, Regulatory, Supply Chain, Commercial) to develop detailed CMC project plans required to successfully progress an asset from pre-clinical through commercialization
  • Lead the scientific assessment of development programs related to all CMC aspects as the CMC project lead
  • Manage CMC timelines and budget; bring focus to risk management activities and implement processes to identify risks, maintain risk registry and proactively execute mitigation plans to help ensure effective program execution
  • Drive timely and data-driven decision making, and facilitate strategic discussions within CMC and with external partners to inform product development
  • Drive continuous improvement of process and data quality, through streamlining and optimizing processes; automation; and digitalization


What you have to offer:

  • An Advanced Degree (MS/PhD) in Pharmacy, Chemistry, Biopharmaceuticals, Biochemistry or Biology with several years professional experience in an international, pharmaceutical environment
  • Sound knowledge of working in different scientific/technical CMC development functions (process development, pharmaceutical and/or analytical development, manufacturing). Documented experience in CMC regulatory affairs would be a plus
  • In depth CMC development knowledge in either early or late stage projects with sound understanding of all stages of drug development; Experience with regulatory filings for biologicals (IND/IMPD, BLA/MAA) is considered a plus
  • Leadership, seniority and assertiveness, capable of leading CMC teams and aligning with other functions on the program
  • 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


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 3581 (please indicate for inquiries)

We look forward to your application!

*BioNTech does not differentiate on the basis of gender, political opinion, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other aspect of personal status. We are committed to creating a diverse and inclusive environment and are proud to be an equal opportunity employer. Most important – it’s a match!

BioNTech - As unique as you