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Jetzt bewerben: Manager* AS&T Stability Studies bei BioNTech AG – Arbeitsort Mainz
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BioNTech AG
Mainz
Stellenausschreibung
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.
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.
Manager* AS&T Stability Studies
This position is limited to one year.
Manager* AS&T Stability Studies
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:
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/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 in QC within a Good Manufacturing Practice (GMP) environment
- Deep knowledge in planning and managing stability studies including data evaluation (e.g. trending)
- 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:
- 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 5199 (please indicate for inquiries)
We look forward to your application!
BioNTech - As unique as you
www.biontech.com
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 5199 (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
www.biontech.com
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