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Biotech CMC Programme Lead (m/f)

Posted 30 May 2018

Darmstadt, Hesse - Germany

Req Id 176926

Details

A career is an ongoing journey of discovery: our 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.


Your Role:

Lead the CMC development programme team in order to drive and set the CMC strategy and activities of the relevant molecule(s), delivering quality products and processes with appropriate validation and regulatory documentation for a “Right First Time” submission, and within agreed timelines and budget. Represent the Global Biotech Development function within the R&D global team , providing options and innovative solutions to drive the project forward, with full transparency of timelines and costs. Set the strategy, drive, facilitate and manage all process and product development activities within Global Manufacturing & Supply in order to provide the agreed deliverables. Serve as the interface between the R&D Global Team and the Global Manufacturing & Supply Functions. Build, manage and control the programme related cost. Monitor the preparation and review the CMC section of regulatory dossiers and lead CMC interaction with regulatory agencies . Serve as interface with the Global Regulatory Affairs group. Be the interface with CMOs/CROs for the development activities.

Who you are:

  • PhD (preferably) or MSc (must) in life science discipline is a must.
  • 5-10 of experience in Process Development/Manufacturing in the biotech industry; solid knowledge of different types of NBEs CMC development, manufacturing operations, clinical development and regulatory landscape
  • Demonstrated success in operating within a global matrix organization
  • Fluent in English, both oral and written; additional languages (German or French) are an asset
  • Ability to lead team

What we offer: We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

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