Analytical Expert for Trace & NDSRI Analytics and Mass Spectrometry

At Roche you can show up as yourself embraced for the unique qualities you bring. Our culture encourages personal expression open dialogue and genuine connections where you are valued accepted and respected for who you are allowing you to thrive both personally and professionally. This is how we aim to prevent stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche where every voice matters.

The Position

Global Technical Development (PTD) is an organization of over two thousand people globally that are integral for the mission of Roche to develop meaningful medicines for patients. Therefore PTD actively collaborates and develops creative technical solutions to bridge early-stage late-stage and commercial product needs. The mandate of the group is to reliably deliver the pipeline and supply quality products to patients. The group excels in its work through innovation teamwork dedication and mutual respect and contributes every single day continuously improving what it does.

The Analytical Development & Quality Control department (PTDC-A) is part of the Global Technical Development (PTD) and it is responsible for ensuring that our synthetic drug substances and drug products are developed with a robust control strategy for clinical trial releases.

Within PTDC-A you will join the Hyphenated & Special Technologies (HST) section that provides key scientific customer support with mass spectrometry (MS) separation sciences and other innovative specialty technologies. Together with more than 15 mass spectrometry experts you will verify the safety and quality of our molecules by identity testing and their characterization and quantification. Our portfolio includes small molecules as well as peptides and oligonucleotides.

The Opportunity

We are looking for an analytical scientist in HST who will be mainly responsible for the following:

• Perform hands-on qualitative and quantitative analysis of organic and elemental impurities (including NDSRI Extractables & Leachables and Genotoxic Impurities) across drug substances and products utilizing a broad suite of advanced MS and chromatography platforms (LC-HRMS GC-MS Headspace-GC-MS ICP-MS IC).

• Lead the development validation and quantitative determination of Nitrosamine Drug Substance Related Impurities (NDSRI) in compliance with quality standards (non-GMP/GMP).

• Serve as the primary analytical coordinator for projects managing requests and ensuring seamless communication with Analytical Project Leaders and cross-functional stakeholders.

• Act as the internal N-Nitrosamines and Trace Analytics expert advising cross-functional teams (e.g. Process Development Regulatory Affairs Manufacturing) on control strategies and technical solutions.

Who you are

As a suitable candidate you bring a Masters or a PhD in Natural Science (Chemistry Pharmacy Food/Environmental/Polymer Chemistry or equivalent) and proven work experience with GC-MS and LC-HRMS. Experience in the application of GxP requirements is a plus.

Further qualifications are:

• Proven practical experience in impurity quantification (NDSRI Extractables & Leachables genotoxic impurities) the development/validation of chromatographic and MS methods and familiarity with MS software.

• A pragmatic proactive and solution-oriented mindset with an interest in continuous process improvement (lean/digital tools).

• An excellent team player with strong communication skills curious and comfortable working with colleagues in a matrix environment.

• Very good knowledge of spoken and written English

Please submit your up-to-date CV and a motivation letter detailing your relevant experience in MS and NDSRI/Trace Analytics.

Who we are

A healthier future drives us to innovate. Together more than 100000 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.

Lets build a healthier future together.

Roche is an Equal Opportunity Employer.