Analytical Development Expert Nitrosamines

Analytical Development Expert Nitrosamines

Grünenthal Group

Aachen, Germany

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. Can 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;
• 5 to 8 years of professional experience in analytical development or QC Lab leadership roles (LC/MS experience is a plus);
• Experience in the GMP regulated environment;
• Proven expertise in instrumental analytics;
• Proven expertise in the structure elucidation of unknown substances and in the establishment of the associated analytical methods and their validation;
• Previous experience in nitrosamines analytical development is desirable;
• Basic knowledge of project management.

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