Grünenthal

CMC Project Lead (f/m/d)


PayCompetitive
LocationAachen/North-Rhine-Westphalia
Employment typeFull-Time

This job is now closed

  • Job Description

      Req#: 43623

      If you’re passionate about changing lives for the better, this is the opportunity you’ve been waiting for. In Research & Development, we’re continuously exploring innovative new treatment options to make a stronger, more positive impact on the lives of the patients we serve. You’ll work with talented colleagues in a state-of-the-art Research & Development environment, developing innovative medicines that change the live of patients for the better and help us make progress towards our vision of a world free of pain. Join us today, and discover the difference you can make.

      What the job looks like
      Each day you'll enjoy a variety of challenges, such as:

      • Lead global CMC drug development projects from candidate profiling until successful regulatory approval and transfer to commercial manufacturing in a fully outsourced setting
      • Define targets and strategy for CMC drug development with a focus on analytical development related activities
      • Oversee the external execution of CMC drug development and manufacturing activities
      • Lead scientific discussions on analytical development and testing topics with external service providers and internal stakeholders
      • Define specifications for drug products, drug substance, excipients, starting materials, and raw materials in alignment with the CMC program team and in compliance with regulatory requirements and internal policies
      • Review analytical procedures, validation plans and reports generated by external service providers
      • Generate and oversee CMC project plan and budget
      • Manage CMC project risks including project analyses and elaboration of mitigation actions
      • Represent CMC function in global program team to provide input into the global program strategy and development plan, as necessary
      • Facilitate exchange of project information and alignment with all relevant internal and external stakeholders
      • Establish alliance management with commercial and internal partners ensuring an effective cooperation

      What you'll bring to the table
      To make the most of this role and truly thrive:

      • University master degree and PhD preferably in Chemistry or Pharmacy
      • At least 5-10 years of experience in the technical development of innovative pharmaceutical products
      • Strong scientific background in analytical method development and validation, ideally for both, drug substance and drug product
      • Broad experience over all phases of drug development and product registration is a plus
      • Passionate and experienced in project leadership and cooperating with external partners
      • Proven ability to effectively communicate through and work in a matrix organization in a multinational company
      • Excellent communication, negotiation and conflict management skills
      • Broad international/intercultural working experience
      • Fluency in (business) English, German language skills is a plus

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  • About the company

      Grünenthal is a global leader in pain management and related diseases. Our purpose is to change lives for the better – and innovation is our passion. We focus our activities on moving towards our vision of a world free of pain.