Analytical Development Expert Nitrosamines (m/f/d)

Gr?nenthal GmbH; Aachen; Hybrid; EUR 60.000 - 80.000; Vollzeit

Zusammenfassung

A leading pharmaceutical company based in Aachen, Germany is seeking an Analytical Development Expert for a fixed 2-year contract. The ideal candidate should have a degree in Chemistry or a relevant field and 3-5 years of experience in analytical development. Responsibilities include leading technical activities related to genotoxic impurities and coaching junior analysts. This position offers a hybrid work model as part of an international team focused on quality and innovation.

Qualifikationen

• 3-5 years of professional experience in analytical development or QC Lab leadership roles.
• Experience in nitrosamines analytical development is required.
• Proven expertise in instrumental analytics and structure elucidation of unknown substances.

Aufgaben

• Lead the technical activities for genotoxic impurity analysis.
• Coach nitrosamines analysts and provide insights to reformulation specialists.
• Create specifications for pharmaceutical quality assessment.

Kenntnisse

Analytical development

GMP regulated environment

LC/MS experience

Project management

Ausbildung

Degree in Chemistry or relevant field

Master or PhD

Jobbeschreibung

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Analytical Development Expert Nitrosamines (m/f/d)

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:

• 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. Act independently as main technical contact with external testing laboratories.
• Lead drug product analytical investigations in close collaboration with the nitrosamines core experts and extended teams (both global and/or site experts).
• Serve as daily technical coach to nitrosamines analysts, and provide input and technical insights to reformulation specialists
• Creation of specifications to assess the pharmaceutical quality of active ingredients, pharmaceutical formulations and special material required for use in nitrosamines investigations
• 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
• 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:

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

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 28 countries across Europe, Latin America and the US. Our products are available in more than 100 countries. In 2024, Grünenthal employed around 4,300 people and achieved sales of € 1.8 billion.