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CMC Program Lead Biosimilar (m/f)

Posted 23 Jul 2018

Darmstadt, Hesse - Germany

Req Id 172285

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 project 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 Biotech Manufacturing & Development function within the Biosimilar Global Product Team of the assigned molecule(s), providing options and innovative solutions to drive the project forward, with full transparency of timelines and costs. Set the CMC strategy, drive, facilitate and manage all process and product development activities. Build, manage and control the project related cost. Monitor the preparation and review the CMC section of Regulatory dossiers and serve as interface with joint committees. Be the interface with CMOs/CROs for the development activities. Drive risk management through risk assessment and the development of mitigation plan(s).

 

Who you are:

  • PhD (preferably) or MSc in life science discipline
  • 5-10 years of experience in R&D and/or Process Development/Manufacturing in the biotech industry; solid knowledge of NBE/Biosimilars 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

 



What we offer: With us, there are always opportunities to break new ground. 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!

Curious? Apply and find more information at

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