CMC Project Lead (f/m/d)

Country:  Germany
City:  Aachen
Department:  Research & Development
Job ID:  36743


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: 

  • Translating the overall drug development strategy into a global CMC strategy and CMC milestones 
  • Executing CMC drug development projects in a fully outsourced setting (NCE and NBE, as well as NTE/LCM) from candidate selection until successful regulatory approval and transfer to commercial manufacturing
  • Generating and overseeing the CMC project plan and associated budget
  • Managing the preparation of CMC-related development topics for interaction with regulatory authorities (e.g. IMPD, Briefing Books for Scientific Advice, MAA)
  • Managing CMC project risks including project analyses and elaboration of mitigation actions
  • Representing CMC in Program Teams to discuss and align on cross-functional development topics
  • Facilitating exchange of project information and alignment with all relevant internal and external stakeholders
  • Establishing 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, you should have:

  • University master degree and PhD in Pharmacy, preferably with a focus on pharmaceutical technology
  • Several years of experience in technical / CMC product development, ideally over all phases of drug development and product registration
  • Track record of several years of experience in international leadership and project management on senior level in the pharmaceutical or biotech industry
  • Effective communication through and work in a matrix organization in a multinational company
  • Fluent (business) English skills, German language skills is a plus
  • Experience in project management and cooperating with external partners
  • Excellent communication, negotiation and problem solving skills
  • Broad international/intercultural working experience
  • Basic knowledge of patent relevant topics necessary in R&D



About Grünenthal

Grünenthal is a global leader in pain management and related diseases. As a science-based, privately-owned 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 focussing 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 29 countries across Europe, Latin America and the US. Our products are available in more than 100 countries. In 2020, Grünenthal employed around 4,500 people and achieved sales of € 1.3 bn.

Your HR contact:
Simona Frings

Meet our teams
Website: careers.grunenthal.com
LinkedIn: Grunenthal Group
Instagram: @grunenthal

Meet our teams
Grunenthal Group