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A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Roche.
Quality Control (QC) Basel/Kaiseraugst consists of approximately 350 employees, organized into 7 departments with subordinate structures. It serves as a central key point for producing high-quality medicines.
In this role, you will support the PTDA Analytical Development Team in Basel with the evaluation and development of innovative analytical methods. Your main tasks and responsibilities in this position will be:
Introduce, develop, and enhance spectroscopic methods such as benchtop NMR implementation for pharmaceutical Quality Control (QC) for applications in a GMP environment for IPC, DS and DP release and stability testing in Biologics, focusing on excipient/surfactant quantification with high protein backgrounds
Develop and validate analytical procedures for identification and quantitative determinations, support of regulatory submission activities.
Foster GMP method development from scratch for biologics (DS/DP/IPC), focusing on excipient/surfactant quantification in complex matrices as part of an international project team including a comprehensive method risk assessments based on experimental results and perform analytical performance experiments (method qualification) demonstrating excellent precision, accuracy, and linearity.
Establish initial SOPs for the system and the first method setup, comprehensive documentation, and validation efforts.
Develop user management protocols and standardization strategies to simplify user interfaces, as well as methods for routine end-users.
Manage key operational aspects of the platform, including defining SSTs and regular testing procedures in alignment with pharmacopeias, negotiating service agreements, and overseeing instrument maintenance.
Facilitate smooth and seamless information exchange with clients, other laboratories within and outside QC, and local and global teams. You will participate in cross-functional project teams.
You are a positive thinking, integral and self-reflective personality with strong teamwork skills. With this in mind, you bring an open and collaborative attitude and mindset that it takes to work successfully within your team and across departments. You trust yourself and others, take responsibility and live an open speak-up culture.
Completed studies (Master's degree) in a scientific field such as Biology, Chemistry, Pharmacy, Biotechnology; a PhD is a plus.
Proven practical experience in developing and optimizing NMR methods in a GMP environment.
Broad NMR spectroscopy expertise: Benchtop NMR expertise, GMP method implementation, advanced Topspin skills for measurement automation and method development, Small molecule assignments & quantification, protein backbone/side-chain assignments, NMR titration, relaxation and RDC experiments (for structural elucidation), Solution NMR (data acquisition, processing, analysis).
Highly flexible, service-oriented, and customer-focused, with a strong commitment to meeting client needs and providing exceptional support.
Capable of working independently, quick to learn, and able to comprehend complex challenges in an industrial setting.
Ready to take the next step? We'd love to hear from you. Apply now to explore this exciting opportunity!
A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Let’s build a healthier future, together.
Roche is an Equal Opportunity Employer.
