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Small Molecule Regulated Bioanalytical and Biosample Operations Expert

2703 Roche Products Limited

 
Welwyn, GB-HRT
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2703 Roche Products Limited
Small Molecule Regulated Bioanalytical and Biosample Operations Expert

At Roche, we believe it's urgent to deliver medical solutions right now - even as we develop innovations for the future. We are passionate about transforming patients' lives and we are fearless in both decision and action. And we believe that good business means a better world.
That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow.

In Roche's Pharmaceutical Research and Early Development organisation (pRED), we make transformative medicines for patients in order to tackle some of the world's 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.

pRED's Pharmaceutical Sciences (PS) 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 tomorrow's medicines. PS supports discovery and development across the whole value chain from target assessment to on-market.

This position is located in the Biosample Operations and Regulatory Bioanalysis chapter within PS, which is accountable for developing efficient End 2 End patient-centric Biosample strategies ensuring maximum utilisation for every sample and ensures assay readiness to provide PK, ADA and BioM data, data context and ultimately deliver robust and fit for purpose BioX regulatory filings

Job mission

This pivotal scientific enabling role will be the group expert in small molecule regulatory bioanalysis and a focus on alignment across the chapter ensuring we have the technical and leadership capabilities, architecture and strategy to create exceptional value for our people, the portfolio and for patients.

Your impact

  • The Regulated Bioanalytical scientific expert for small molecules, setting the strategy, influencing regulations, the main focus for small molecule issue resolution/escalation/filing and generally driving the science

  • Will develop solutions and tools to ensure harmonisation and efficiencies within and across the chapters, where all synergies are maximised and fully developed

  • Will build trustful relationships and effective collaboration with internal and external partners including regulators and leading experts

  • Will be seen as a coach within the chapter, promoting development opportunities and promoting key behaviors and new ways of working

Your profile
  • Minimum of a Degree with substantial (+10 years) relevant pharmaceutical research and development experience.

  • Demonstrated experience in the area of bioanalytics including leadership, compliance and scientific quality, optimal use of resources, CRO monitoring and functional interface. Also a deep understanding of Biosample Operations and Bioanalytical laboratories and a knowledge in these areas from across the industry

  • A track record and expertise for strategic planning, harmonisation and seeking optimal efficiencies

  • You exhibit a growth mindset. You ask for feedback and act on it. You embrace opportunities to gain new skills and perspectives and provide honest feedback to others to help them grow.

  • You are obsessed with meeting customer needs. You put yourself in your customers place and act boldly with them to bring better results to patients.

  • You are able to radically simplify and prioritize for impact. You invest your time in things that accelerate progress for patients. You stop doing things that do not.

Your location

This position is located in Welwyn or Basel

You're someone who wants to influence your own development. You are looking for a company where you receive the opportunity to pursue your interests across functions and geographies. Working in a multi-cultural environment motivates you.

Are you ready to apply? We want someone who thinks beyond the job offered - someone who knows that this position can be a rare springboard to many other opportunities at Roche.

Roche embraces diversity and equal opportunity in a serious way. We are committed to building a team that represents a variety of backgrounds, perspectives, and skills. The more inclusive we are, the better our work will be.

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Job Level:

Individual contributor
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