(Associate) Director* CMC Expert Protein Formulation & Drug Product


Become a member of the BioNTech Family!

As a part of our team of more than 5.000 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.


(Associate) Director* CMC Expert Protein Formulation & Drug Product 


Your main responsibilities are:

  • Support the selection of CDMOs and related CROs, develop detailed CMC project plans for the development and manufacturing of protein-based therapeutics and antibody drug conjugates in close collaboration with the CDMOs/CROs
  • Represent formulation and drug product expertise in assigned development programs
  • Create, review, and approve (external) project documentation, including development reports, risk analysis, and qualification/validation reports according to regulatory guidelines
  • Manage CMC timelines with respect to formulation and drug product development activities, oversee budget and implement risk management, including proactive mitigation plans to help ensure effective program execution
  • Drive timely and data-driven decision making, and contribute to strategic discussions within CMC as well as with other internal stakeholders and external partners
  • Drive continuous improvement of formulation and drug product development as well as data quality, through optimizing technologies, automation, and digitalization.



What you have to offer:

  • Master’s degree or preferably PhD, in Pharmacy, Chemistry, Biopharmaceuticals, Biochemistry, Biology, or a comparable field with at least 5 years of relevant professional experience in an international and highly regulated environment
  • Broad experience in protein formulation as well as drug product delivery and process technologies. Experience with high-concentration formulations and ADCs is considered a plus
  • Proven experience in CMC development of early- and/or late-stage projects, including strategy definition and strategy execution, with a sound understanding of all stages of the drug development process.
  • Experience with generation of regulatory documents and regulatory filings for biologicals (IND/IMPD, BLA/MAA)
  • Leadership/management skills and assertiveness, capable of working in cross-functional CMC teams and with external stakeholders
  • Excellent communication and negotiation skills as well as ability to communicate complex technical matters in a clear and concise way (e.g., to senior management)


Benefits for you:


  • Flexible Working Time
  • Mobile Office
  • Work from EU Countries
  • Company Pension Scheme
  • Childcare
  • Jobticket
  • Company Bike
  • Leave Account
  • Fitness Courses

... and much more.


Have we kindled your pioneering spirit? 


Then apply now for our location Mainz Goldgrube 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 5435 (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