At BioNTech, you will be responsible for supporting our project teams from start of the development of biologics up to launch in major markets.
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.