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The Position

Scientist in Biomarkers Externalization and Validation (m/f/d)

In Roches Pharmaceutical Research and Early Development organisation (pRED) we make transformative medicines for patients in order to tackle some of the worlds toughest unmet healthcare needs. At pRED we are united by our mission to transform science into medicines. Together we create a culture defined by curiosity responsibility and humility where our talented people are empowered and inspired to bring forward extraordinary life-changing innovation at speed.

pREDs Pharmaceutical Sciences group enables discovery and development of safe and effective therapeutics at optimal doses in relevant populations with a vision to power translation continuously improve the accuracy of our predictions and accelerate the development of tomorrows medicines. PS supports discovery and development across the whole value chain from target assessment to on-market.

This position is situated within the Bioanalytics and Biomarkers (BioAM) Chapter of the Pharmaceutical Sciences (PS) function. Our chapter is accountable for developing Bioanalytical and Biomarker methods and implementing them in Roche clinical studies to help guide drug development. We closely collaborate with different disease therapeutic areas and other functions to convert hypotheses into innovative therapeutics.

As a Scientist in Biomarkers Externalization and Validation (m/f/d) you will play a key role in shaping and executing biomarker strategies for Roche clinical trials.

Your Impact

• Supporting biomarker assessments in non-clinical and clinical studies and providing data interpretation to enable informed project decisions

• Leading in-house assay development kit characterization and assay transfer outsourcing and validation at CROs to ensure high-quality decision-enabling data

• Providing technical leadership in developing and validating bioanalytical and biomarker methods with a strong focus on LBAs and expertise in LC-MS-based methodologies

• Ensuring all work complies with global and local bioanalytical guidelines and GxP by overseeing data quality and regulatory documentation (plans and reports)

• Collaborating proactively across internal functions and with external partners and CROs to deliver fit-for-purpose biomarker assay solutions and resolving technical issues

• Driving innovation by integrating new technologies supporting regulatory and translational efforts and fostering a collaborative agile chapter culture

Your Profile:

• You hold a PhD in Biology Immunology or related field or a Masters with 3 years of relevant CRO experience and proven expertise in biomarker assay development transfer and validation in regulated environments

• Internal applicants not holding a PhD but with relevant work experience as described are welcome to apply

• Furthermore you have strong hands-on expertise in ligand-binding assays (ELISA ELLA Simoa Elecsys MSD). Familiarity with LC-MS-based biomarker methods and technologies like Olink is a plus.

• We can trust in your solid knowledge of bioanalytical guidelines GxP compliance and fit-for-purpose validation principles with experience supporting pharmacodynamic and PK/ADA biomarker assessments

• You have demonstrated success in CRO oversight troubleshooting and ensuring high data quality and regulatory compliance

• Also important - your recognized scientific credibility through publications or conference presentations with a collaborative and proactive approach to teamwork and innovation

• Besides you have a strong customer- and patient-focused mindset and you are able to communicate fluently in English. German proficiency is advantageous.

Your final Scientific Career Ladder (SCL)-Title will be evaluated according to your individual scientific experience. This also applies to the potential classification under the collective wage agreement for academically educated employees in the chemical industry.

Your application

Please upload your current resume and your latest certificates of education.

We are looking forward to your application!

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