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.
As part of the CMC DP Support team, you will contribute to the design and execution of CMC studies to contribute to technical reports for regulatory filing. Your main responsibilities are:
Planning, execution and reporting (incl. official reports to external partners or authorities) of numerous types of CMC laboratory experimental studies (e.g. in use and point of use stability, process compatibility and bridging of methods to a clinical setting)
Liaising with various departments and external partners to devise experimental plans and strategies to serve the CMC sections of Regulatory documents
Coordination and management (incl. self-responsible contacting manufacturers, CMOs, CROs etc.) of activities related to the material logistics, supply and inventory management for various CMC experiments and scenarios
Independent and autonomous data processing, evaluation, documentation of experiments, and writing of reports (internal & official reports)
Responsibility for instruments, laboratory management and supervision of Student Assistants and Research Associates
What you have to offer.
PhD in a relevant scientific area
Experience in design process for formulation or product development gained in a pharmaceutical or biotech environment
Knowledge or awareness of the regulatory documentation process for drug development
Hands on experience with regulatory filings is preferable
A multi-disciplinary background gained through working in analytical and pre-clinical development departments is preferable
Strong planning expertise and a quality oriented approach to report writing
Coordination and management of internal and external partners
Some experience in laboratory management and supervision of Student Assistants and Research Associates
Fluency in English both written and spoken is a requirement; knowledge of German is advantageous
Benefits for you.
Company Pension Scheme
... 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 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
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