Senior Principal Scientist Extractables & Leachables

Senior Principal Scientist Extractables & Leachables

Lonza

Basel, Switzerland

What you will do:

• You will perform extractables/leachables (EL) and elemental impurities (EI) assessments according to Lonza procedures and best scientific practices;
• Act as Lonza’s global EL/EI subject matter expert (SME) and ensure regulatory compliance of the global EL/EI strategies;
• Supervise and manage EL/EI laboratory studies (HS-GC-MS, GC-MS, LC-UV-MS) and other hyphenated analytical methodologies) to support DPS projects and external services;
• Lead and manage a team of scientists, ensuring effective resource use, equipment maintenance, and safety compliance;
• Drive innovation and technical strategy projects, contribute to publications, and evaluate new technologies;
• Support department initiatives and maintain cGMP qualification and documentation standards;
• Perform other duties as assigned.

What we are looking for:

• PhD in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or related field;
• Proven expertise in analytical methodologies, such as trace analysis;
• Working knowledge of extractables/leachables (technical and regulatory); track record of regulatory submissions is an asset;
• People Management experience and strong supervisory skills;
• Strong reporting and scientific skills with ability to interpret complex data;
• Excellent communication skills and fluency in English.