Associate Director CMC IVAC
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 IVAC
Your main responsibilities are:
- Coordination of cooperation with the functions of the departments (including process development, analytics, quality, regulatory affairs, production, quality control and project management)
- Independent coordination and scientific guidance of development projects with regard to all CMC aspects, preparation of reports on project progress, identification of project risks and development of corresponding mitigating measures
- Project coordination with involved functions beyond the CMC area such as Clinical Development, Preclinical Development, Clinical Safety and Program Management
- Preparation of data-driven decision making and facilitation of strategic discussions within CMC and with external partners
-Monitor regulatory requirements in the area of mRNA therapeutics and individualized cancer therapeutics and initiate necessary technical development projects accordingly
What you have to offer:
- Advanced degree (MS/PhD) in Chemistry, Biopharmaceuticals, Pharmacy, Biochemistry or Biology with several years of professional experience in an international pharmaceutical environment.
- Strong knowledge of working in various scientific and technical CMC development functions, including process development, analytical development, and manufacturing.
- Preferably, experience with RNA or DNA-based products.
- Ideally, some experience in supporting the transfer of pharmaceutical products from development to market.
- Experience with regulatory filings for biologicals (IND/IMPD, BLA/MAA) is a plus.
- Excellent communication and negotiation skills with the ability to communicate complex technical matters clearly and concisely to senior management. Experience in defining and executing strategy is required.
Benefits for you:
- Flexible Working Time
- Mobile Office
- Work from EU Countries (up to 20 days per year)
- 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 6775 (please indicate for inquiries)
We look forward to your application!
*BioNTech does not tolerate discrimination, favoritism, or harassment based on 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
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