Expert Special Analytics – Particle Characterization

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The Quality Control department in Basel / Kaiseraugst is responsible for the analytical testing of commercial products and active ingredients. Within this department, the “Complaints, Counterfeits & Special Analytics” group, as part of the “Analytical Science and Technology” (ASAT) organization, has the task of analyzing complaints and suspected counterfeits of Roche products, to support customers in analytical troubleshooting activities and to establish new analytical technologies at the Kaiseraugst production site and the Roche network.

The opportunity

Within this role you support the Special Analytics team regarding analytical investigations with special focus on the characterization of particles and residues:

• Independently perform a variety of analytical methods to investigate market complaints, suspected product counterfeits, and perform analytical troubleshooting. This includes the handling of investigation materials from the areas of synthetic molecules (e.g., tablets, capsules, powders), biologics (e.g., lyophilized products, vials, syringes), medical devices (e.g., autoinjectors, needle safety devices), raw materials and active substances.
• Conduct characterization of particles, residues, and impurities using various analytical techniques, including infrared spectroscopy, Raman spectroscopy, electron microscopy (SEM/EDX), and optical microscopy. This also involves preparing and processing samples from complex matrices for further analytical investigations.
• Efficiently and professionally handle special analysis, ensuring timely reporting and documentation results in full compliance with Good Manufacturing Practice (GMP) guidelines.  
• Participate actively in analytical transfer and validation projects.
• Ensure smooth and seamless information exchange with clients, other laboratories - both within and outside the quality control (QC) department - as well as local and global contacts and teams.
• Oversee the management of analytical instruments, including performing or coordinating functionality tests, qualifications, and maintenance for the group's analytical instruments
• Proactively contribute to the continuous improvement of technical analytics standards, enhance workflows, and reduce operational costs through constructive suggestions and innovative ideas.

Who you are

• Completed studies (Master's degree) with a scientific background (e.g., Chemistry, Pharmacy, Biotechnology, Chemical Engineering) or training with several years of professional experience in the field of pharmaceutical analytics
• Experience with spectroscopic and microscopic techniques for the analysis of particles und residues is advantageous.
• You have professional proficiency in English and German.
• GMP experience in a laboratory environment is required.
• Experience in deviation handling and root cause analysis is considered as an advantage.
• You take an active interest in data and digital topics and are eager to use IT applications to simplify data evaluation and reporting. 
• Highly flexible and customer-focused, you bring a strong service orientation, with an emphasis on understanding and meeting client needs, in addition You are independent, quick to learn able, and excel at understanding and addressing complex challenges in an industrial environment.
• You demonstrate a willingness to work on weekends or outside regular hours during the week, if operational needs require.

Ready to take the next step? We'd love to hear from you. Apply now to explore this exciting opportunity!

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