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AbbVie is hiring a

Head of Drug Product Lead II (all genders) - permanent, fulltime

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Ludwigshafen, Ludwigshafen
Posted 9 hours ago
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Job Description

Joining AbbVie you will be leading a group of highly skilled Technical Leads who oversee and represent all aspects of parenteral Drug Product commercial support and late-stage development including formulation, primary packaging, and manufacturing process as well as playing a translational role to the application/device system in global product development teams. In addition to this, you'll be driving globally aligned strategies for late-stage development concepts.

 

Your responsibilities are: 

  • Leadership of DP Lead team II in Ludwigshafen
  • Leading drug product leads who oversee and represent all aspects of parenteral drug product commercial support and late-stage development including formulation, primary packaging and manufacturing process as well as playing a translational role to the application/device system in global product development teams
  • Leading CMC leads overseeing all parts of drug substance, drug product, analytical and device aspects of a project
  • Development and management and driving the execution of global goals, projects and initiatives to improve biologics CMC drug product development and commercial support strategies
  • Driving globally aligned strategies for late-stage development concepts and assuring delineation concepts with R&D allowing smooth handover of projects
  • Education and training of employees and pharmaceutical personnel in particular with regard to the proper development and manufacture of biological products
  • Review and approval of GMP-compliant and regulatory documents (such as IMPD, IND, CTD for clinical trials, and BLA, NDA, PAS for market submissions)
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