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The Position
The Opportunity
At Roche, we believe in transforming cutting-edge science into life-changing medicines. As a Scientist in Biomarkers Externalisation and Validation within our Bioanalytics and Biomarkers (BioAM) Chapter in Welwyn, you'll play a crucial role in shaping and executing biomarker strategies that directly impact the development of our innovative therapies. You'll collaborate closely with internal teams and CROs to ensure we generate high-quality, decision-enabling biomarker data that drives clinical development forward.
Key responsibilities will include:
* Leading the external development and validation of biomarker assays to support non-clinical and clinical studies
* Managing CRO collaborations and overseeing assay transfer, assay validation, monitoring and troubleshooting performance and data quality
* Applying your expertise in ligand binding assays (LBAs) and LC-MS-based methods across diverse sample types
* Ensuring regulatory compliance and fit-for-purpose assay validation principles (GxP and bioanalytical guidelines)
* Contributing to regulatory documentation and enabling translation of biomarkers and methodologies from early to late stage
* Driving innovation by integrating new assay technologies and shaping analytical strategies for biomarker measurements
* Collaborating cross-functionally with biomarker leads, clinical teams, and external partners
Who You Are
You're a collaborative and scientifically curious individual who thrives in a fast-paced, agile environment. You bring technical depth and a solutions-focused mindset to complex biomarker challenges. With your experience in assay outsourcing and biomarker method validation, you're ready to make a difference in patients' lives by delivering data that matters.
* A degree in Biology, Immunology or related field (PhD preferred), with a track record of relevant experience in assay development and validation
* Strong technical expertise in ligand binding assays (ELISA, Simoa, ELLA, MSD, etc.)
* Familiarity with LC-MS biomarker methods and broader platforms (e.g., Olink)
* Solid understanding of bioanalytical guidelines, GxP, regulatory expectations, and fit-for-purpose validation principles.
* Proven track record in managing CROs and ensuring data quality and regulatory compliance
* Strong communication skills and the ability to collaborate across matrixed teams
* Scientific credibility demonstrated by relevant publications and presentations at external conferences (preferred).
Who we are
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.
The statements herein are intended to describe the general nature and level of work being performed by employees, and are not to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. Furthermore, they do not establish a contract for employment and are subject to change at the discretion of Roche Products Ltd. At Roche Products we believe diversity drives innovation and we are committed to building a diverse and flexible working environment. All qualified applicants will receive consideration for employment without regard to race, religion or belief, sex, gender reassignment, sexual orientation, marriage and civil partnership, pregnancy and maternity, disability or age. We recognise the importance of flexible working and will review all applicants’ requests with care. At Roche difference is valued and we are proud to be an equal opportunity employer where you are encouraged to bring your whole self to work.
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