NBE CMC Expert (f/m)
Boehringer Ingelheim
Biberach, Baden Wuerttemberg, DE
vor 24 Tg.

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.
  • Requirements

  • 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
  • Our benefits

  • 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!

    Contact

    For further information please contact Recruiting Services :

    Mrs. Verena Freudenreich, Tel : +49 (0) 7351 - 54 17 50 92

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