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 expert knowledge and relevant industrial experience in CMC development of biologicals you make a critical contribution to Boehringer Ingelheim.
Tasks & responsibilities
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 taking current & evolving regulatory requirements into consideration.
Moreover, you identify critical CMC development issues and drive strategies and implementation for their resolution.
In addition, you work closely with CMC regulatory affairs and ensure alignment regarding regulatory questions and strategies.
You drive development of science to obtain buy-in of regulatory agencies, together with appropriate line function subject matter experts and project management.
Ph.D. or Master degree in Pharmacy, Chemistry, Biopharmaceuticals, Biochemistry or Biology
More than five years of industry experience in a scientific / technical CMC development function (process, pharmaceutical or analytical development) or in CMC regulatory affairs in a biopharmaceutical development organization
Minimum of two years leadership experience in one or more scientific / technical line functions is a plus
Experience with global regulatory filings for biologicals (IND / IMPD, BLA / MAA)
Excellent communication and negotiation skills in English, German language skills are a plus
Good development opportunities with in-house education and various training options
Competitive salary plus bonus payments
Counselling services for all stages in life
Who we are
At Boehringer Ingelheim we create value through innovation with one clear goal : to improve the lives of patients. 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 are powered by 50.000 employees globally who nurture a diverse, collaborative and inclusive culture.
Learning and development for all employees is key, because your growth is our growth.
Want to learn more? Visit boehringer-ingelheim.com and join us in our effort to make more health.
We look forward to receiving your online application!
For further information please contact Recruiting Services :
Mrs. Verena Freudenreich, Tel : +49 (0) 7351 - 54 17 50 92
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