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Analytical Development Expert (m/f/d)

Country:  Germany
City:  Aachen
Department:  Global Operations & Production
Job ID:  44115

 

Our people in Manufacturing & Global Operations share two priorities: getting things done and making things better. If you’re a dynamic person with a positive mindset, you’ll fit in well here. It’s an international team with a powerful spirit of collaboration. Together, we make sure our products meet the highest standards of quality by constantly searching for ways to improve at every stage of our value chain – from the raw materials we buy through to the logistics network that brings our medicines to patients. Join our team and help us make an even bigger contribution to Grünenthal’s future.

 

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

  • Supervision and coordination of analytical development projects;coordination of internal and external project activities for release of APIs and pharmaceutical formulations
  • Monitoring, review and evaluation of project-related documents according to GMP-guidelines 
  • Development and continuous optimisation of analytical methods in collaboration with the laboratory's technical staff
  • Coordination of external CDMOs
  • Scientific and technical support for the LATAM commercial product portfolio
  • Scientific management of projects for the clarification, quantification of genotoxic impurities and establishment of the required analytical methods, in-house or in cooperation with specialised external laboratories, for the Grünenthal portfolio
  • Preparation of dossier chapters on pharmaceutical quality with analytical content (IMPD, CTD, IND) for applications for clinical studies and marketing authorisations
  • Transfer of analytical methods
  • Creation and review of standard operating procedures (SOP)
  • Initiating the implementation and approval of specifications in the LIMS


What you’ll bring to the table
To make the most of this role and truly thrive, you should have:

  • Successfully completed studies as a chemist or pharmacist or equivalent 
  • Professional experience in analytical drug development (analytical method development, validation, troubleshooting)
  • Experience with the preparation of dossier chapters (IMPD, CTD, IND) for clinical trial applications and marketing authorisations
  • Hands on experience in GMP regulated environment
  • Proven expertise in instrumental analysis
  • Fluent written and spoken English, German 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 27 countries across Europe, Latin America and the US. Our products are available in approx. 100 countries. In 2023, Grünenthal employed around 4,400 people and achieved revenues of € 1.8 bn.

Your HR contact: 
Sarah Schäfer

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

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

Apply now »