Manager* AS&T Stability study Program

  • Mainz
  • Work experience
  • Production, manufacturing
  • Quality Management, Quality Assurance
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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.

Manager AS&T Stability Program

As Stability Manager within our Analytical Science & Technology (AS&T) department, you will be making a meaningful contribution to the ongoing development of our RNA production processes. In this role, you will support us on our mission by managing the planning, validation, evaluation and maintenance of External Supplier Operations (ESO) stability programs across the whole manufacturing and testing network.

Your main responsibilities will be:
  • Coordinating and setting-up commercial stability studies at Contract Manufacturing Organization (CMOs) and external labs
  • Writing or reviewing stability reports and protocols and approval of stability relevant regulatory documents for Health Authorities
  • Overseeing QC-stability-related compliance activates, including investigation closure of any Out-of-Specification/Out-of-Specification/Atypical Results/Corrective and Preventive Action events
  • Building and maintaining a working knowledge of current requirements of worldwide regulatory bodies for stability testing of pharmaceutical products
  • Being responsible for analytical / stability storage projects 

What you have to offer.

We are looking for an enthusiastic, committed, and visionary individual, ideally with the following characteristics:
  • University degree in a scientific discipline (Biochemistry, Chemistry, Microbiology, Biotechnology)
  • Several years of practical experience within QC (method development, method validation, stability testing), as well as in in Sterile Manufacturing
  • Several years of work experience in a Good Manufacturing Practice (GMP) laboratory role in a biotech or pharmaceutical QC laboratory
  • Thorough knowledge of Fill and Finish process steps including QC Release testing (Container Closure, etc.) and equipment associated with testing of biopharmaceutical products
  • Proven track record with regulatory inspections (EMA/FDA or other)
  • Profound knowledge of relevant US and EU, EMA, FDA regulatory standards, and GMP as well as the USP (United States Pharmacopoeia), and Ph. Eur. (European Pharmacopoeia)
  • High conscientiousness and detail-orientation
  • High team spirit, excellent collaborating skills, and effective stakeholder management skills
  • Very good communication skills, fluency in German and English

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  and simply send us your application documents using our online form.

If you have any further questions, Johanna Diehl 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 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