Everyone can achieve great things at BioNTech! We develop revolutionary approaches in the fight against cancer and other diseases. BioNTech wants to become the world’s leading biotechnology company for individualized cancer medicine. Over 1000 dedicated, passionate pioneers achieve sensational success and promising breakthroughs time and again by forging new paths – and ensure people all around the world have hope for the future. You too can become a pioneer!
The CMC Expert (CMCE) is a scientific and CMC expert who is responsible for advising on BioNTech’s development projects and programs. In partnership with CMC Regulatory Affairs and key stakeholders, the CMCE will provide guidance and knowledge on CMC development for a variety of projects, as well as participate in strategy development and execution. In collaboration with the project teams, the CMC Expert will provide content for CMC packages and regulatory dossiers following global regulatory guidelines. Finally, the Senior CMC Expert will lead projects to ensure timely completion, all the while refining and implementing processes and procedures to ensure efficiencies.
Here, you’ll achieve greatness.At BioNTech, you will be responsible for supporting our project teams from start of the development of biologics up to launch in major markets. Your job details include:
- 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.
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, 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