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 Senior CMC Expert (SCMCE) is a strategic leader who is responsible for advising on BioNTech’s development projects and programs. In partnership with CMC Regulatory Affairs and key stakeholders, the SCMCE will provide expert level knowledge on CMC development for a variety of projects. In collaboration with the project teams, the Sr. 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.
Senior CMC Expert*
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 and strategic advisor for BioNTech’s development projects with the program teams from start of Development until launch. You define the CMC development strategy on each project team.
- In close collaboration with BioNTech project management and CMC functions, you bring in your cross-functional scientific/technical expertise as well as your sound 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 global regulatory expectations. For this, you lead the teams in regulatory submissions by writing and reviewing relevant documents.
- As a key role in CMC you lead project teams and oversee all CMC projects. You identify critical CMC development issues and proactively implement activities for their resolution.
- With your experience and comprehensive understanding on CMC Regulatory Affairs, you drive the development of the CMC strategy and innovation for our technologies.
What you have to offer.
- An Advanced Degree (MS/PhD) in Pharmacy, Chemistry, Biopharmaceuticals, Biochemistry or Biology with 10+ years professional experience in an international, pharmaceutical environment.
- Sound knowledge of working in different scientific/technical CMC development functions (process development, pharmaceutical and/or analytical development, manufacturing). Documented experience in CMC regulatory affairs would be a plus.
- In depth CMC development knowledge in either early or late stage projects with sound understanding of all stages of drug development; Experience with regulatory filings for biologicals (IND/IMPD, BLA/MAA) is considered a plus.
- Leadership, 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; Experience defining and executing strategy is required
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.
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