NBE CMC Expert
OUR COMPANY At Boehringer Ingelheim we develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company, we focus on long-term performance. We believe that, if we have talented and ambitious people who are passionate about innovation, there is no limit to what we can achieve; after all, we started with just 28 people. Now, we are powered by 50,000 employees globally who nurture a diverse, collaborative and inclusive culture. THE POSITION For our Research & Development (R&D) project teams for biologicals from start of cell line generation up to launch in major markets, we are looking for a NBE CMC Expert. With your sound knowledge and relevant industry experience in CMC development of biologicals, you make a critical contribution to Boehringer Ingelheim. Tasks & responsibilities As CMC Expert, you are leading the comprehensive assessment regarding drug substance and drug product for assigned in-depth evaluations (IDEs) for external assets from the initiation of the evaluation until buy-decision including preparation of respective documentation and transfer to the R&D project team. In your new role, you ensure that CMC risks of in-licensing assets are made transparent and factored in BI´s development plan You make recommendations for go/no-go decisions based on insightful understanding of the potential in-licensing asset’s strengths and liabilities and support the R&D Project Leader by representation of CMC development aspects in the IDE core team. Furthermore, you are acting as CMC Expert for BI´s NBE development projects in R&D project teams from Start of Cell Line Generation until launch in major markets. In close collaboration with project management and individual biologicals CMC development functions, you leverage your cross-functional scientific/technical expertise in biologicals development as well as your sound knowledge of global regulatory guidelines to drive projects’ cross-functional CMC content proactively. As an expert in the field of biologicals, you ensure that the content of CMC work-packages and documentation are phase appropriate, meet state of the art regulatory expectations and enable smooth approval of regulatory submissions by considering current and evolving regulatory requirements. Moreover, you identify critical CMC development issues and proactively drive strategies and implementation for their resolution. Requirements Master´s degree in Pharmacy, Chemistry, Biopharmaceuticals, Biochemistry or Biology with long-term professional experience in an international, pharmaceutical environment Sound knowledge of working in different scientific/technical CMC development functions (cell line, process, pharmaceutical and/or analytical development) and/or in CMC regulatory affairs in a biopharmaceutical development organization In depth NBE CMC development knowledge in all stages of early projects (Start of Cell Line Generation up to Phase I) with sound understanding of all stages of drug development (Start of Cell Line Generation up to BLA/MAA) Experience with global regulatory filings for biologicals (IND/IMPD, BLA/MAA) Experience with development of oncolytic viruses is a plus Leadership, seniority and assertiveness, capable of leading CMC subteams Excellent communication and negotiation skills and ability to clearly and concisely communicate comple
- Standort: Biberach
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