84 days ago on career012.successfactors.eu

Biotech CMC Program Lead

Merck Gruppe

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 Please refer to JobSuchmaschine in your application

Biotech CMC Program Lead

Merck is a leading science and technology company in healthcare, life science and performance materials. Around 50,000 employees in 67 countries work to further develop technologies that improve and enhance life – from biopharmaceutical therapies to treat cancer or multiple sclerosis, cutting-edge systems for scientific research and production, to liquid crystals for smartphones and LCD televisions.


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 R&D/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 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 Product Development Team / Biosimilar Development Team and the Global Manufacturing & Supply Function. Build, manage and control the project related cost. Monitor the preparation and review the CMC section of Regulatory dossiers and serve as interface with the Global Regulatory Affairs group. 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 with various functions
  • Fluent in English, both oral and written; additional languages (German or French) are an asset


What we offer:Your possibilities to develop in our growing company are just as manifold as our product portfolio. We offer a modern and international working environment to unleash your innovative potential in diverse teams, and take responsibility for our employees, products, the environment and society.


Curious? Apply and find more information at come2merck.com