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CMC Project Lead (f/m/d)

Country:  Germany
City:  Aachen
Department:  Research & Development
Job ID:  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




About Grünenthal

Grünenthal is a global leader in pain management and related diseases. As a science-based, fully-integrated pharmaceutical company, we have a long track record of bringing innovative treatments and state-of-the-art technologies to patients worldwide. Our purpose is to change lives for the better – and innovation is our passion. We are focusing all of our activities and efforts on working towards our vision of a world free of pain.

Grünenthal is headquartered in Aachen, Germany, and has affiliates in 28 countries across Europe, Latin America and the US. Our products are available in approx. 100 countries. In 2022, Grünenthal employed around 4,400 people and achieved revenues of € 1.7 bn.

Your HR contact:
Thorsten Hagens

Meet our teams
LinkedIn: Grunenthal Group
Instagram: @grunenthal

Meet our teams
Grunenthal Group

Apply now »