- Production, manufacturing
- Research, development, teaching
Become a member of the BioNTech Family!
We aim to achieve life-changing successes for patients by being innovative, passionate and united,so 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.
- You are acting as CMC Expert for BioNTech’s development projects with the program teams for specific topics or for certain development periods. You provide input into the project by defining the CMC development strategy.
- In close collaboration with BioNTech project management and CMC functions, you bring in your scientific/technical expertise as well as your knowledge of global regulatory guidelines to drive and guide the cross-functional CMC content.
- Together with your colleagues in CMC Regulatory Affairs, you ensure that the content of CMC data-packages and documentation meet state of the art regulatory expectations. For this, you also support the teams in regulatory submissions by writing and reviewing relevant documents.
- You identify critical CMC development issues and proactively implement activities for their resolution.
What you have to offer.
- Advanced Degree in Pharmacy, Chemistry, Biopharmaceuticals, Biochemistry or Biology with 5+ years professional experience in an international, pharmaceutical environment.
- Sound knowledge of working in a scientific/technical CMC development function (process development, pharmaceutical and/or analytical development, manufacturing) with a solid understanding of other functions.
- Experience developing or participating in strategy development and execution is required.
- In depth CMC development knowledge in either early or late stage projects. Experience with regulatory filings for biologicals (IND/IMPD, BLA/MAA) is considered a plus.
- Leadership effectiveness, seniority and assertiveness, capable of leading CMC teams.
- Excellent communication and negotiation skills and ability to clearly and concisely communicate complex technical matters to senior management.
Benefits for you.
- Company Pension Scheme
- Company Bike
- Leave Account
- Fitness Courses
- Mobile Office
- Special Vacation
Have we kindled your pioneering spirit?
If you have any further questions, Andy Wingstrom 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, religion, color, origin, sexual orientation, disability, age and other protected status as required by applicable law. We are committed to creating a diverse environment and are proud to be an equal opportunity employer.
BioNTech - As unique as you