Senior Scientist Project Analytics (m/f/d)

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Ansprechpartner
Nadja Küppers
+49 (0)89 7263 210 – 09
kueppers@ageneo.de
Branche
Biotechnologie
Berufsfeld
QM
Region
Bayern

DAS UNTERNEHMEN

For one of our innovative, world leading biopharmaceutical clients of high-quality biosimilars in Bavaria we are looking for a Senior Scientist Project Analytics (m/f/d).

In this exciting role you will be acting as single point of contact regarding overarching as well as in-depth analytical assessments.
As such you interact with a variety of internal and external customers and ensures the timely delivery of high quality analytical summaries in the form of key documents for development and submission.

IHRE AUFGABEN

  • Be the single point of contact in analytics for internal and external customers
  • Lead and plan analytical activities
  • Ensure timely delivery of analytical project tasks in high quality
  • Represent the analytical team in technical team meetings
  • Closely interact with project management, regulatory CMC, and analytical experts
  • Compile and review overarching documents with focus on analytics (e.g. analytical development masterplan, similarity assessment, DS/DP comparability)
  • Participate in meetings with regulatory agencies (EMA, FDA)
  • Together with experts on individual topics answer requests from authorities with a focus on analytics
  • Present analytical project updates in internal and external meetings
  • Contribute to budget planning activities

IHR PROFIL

  • Degree in biology, chemistry, biochemistry or a related field
  • Min. 3 years’ experience in the biopharmaceutical industry or a highly related field
  • Applied in-depth knowledge of (glyco)protein analytics
  • Passion to deliver against tight timelines
  • Creativity and enthusiasm for working in a dynamic fast growing biopharmaceutical company
  • Fluent in written and spoken English required, German knowledge is desirable
  • Proficient in MS-Office
  • Work permit for Germany is mandatory 

BENEFITS

  • Excellent work and company culture 
  • Working in an exciting scientific environment 
  • A dynamic and innovative working field in a motivated international team
  • Working in the heart of Bavaria
  • Flexibility and additional social benefits