Analytical Development Expert Nitrosamines

Analytical Development Expert Nitrosamines

Country: Germany

Department: Global Operations & Production

Job ID: 44500

Professional | Temporary | Full-/ Part-time | Hybrid

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.

This position is offered as a fixed 2-year contract.

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

1. Lead the technical activities aiming to elucidate/quantify genotoxic impurities, as well as establishment of the required analytical methods, in-house or in cooperation with specialized external laboratories for the Grünenthal portfolio. Can act independently as main technical contact with external testing laboratories.
2. Lead drug product analytical investigations in close collaboration with the nitrosamines core experts and extended teams (both global and/or site experts).
3. Serve as daily technical coach to nitrosamines analysts, and provide input and technical insights to reformulation specialists.
4. Creation of specifications to assess the pharmaceutical quality of active ingredients, pharmaceutical formulations and special material required for use in nitrosamines investigations.
5. Co-lead the root cause investigations with Drug Product Development Experts and Reformulation Specialists. Provide analytical insights to the investigations and act as technical responsible for analytical data generation.
6. Support due diligences for risk assessment of new products.

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

1. Degree in Chemistry or relevant field. Master or PhD is desirable.
2. 5 to 8 years of professional experience in analytical development or QC Lab leadership roles (LC/MS experience is a plus).
3. Experience in the GMP regulated environment.
4. Proven expertise in instrumental analytics.
5. Proven expertise in the structure elucidation of unknown substances and in the establishment of the associated analytical methods and their validation.
6. Previous experience in nitrosamines analytical development is desirable.
7. Basic knowledge of project management.

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 € 1.8bn.