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Senior Scientist Principal Scientist - Immunohistochemistry/Biomarkers

Location: 

Slough, Berkshire, United Kingdom

Job Function:  Research & Early Development
Job ID:  65031

Posting date: 22nd October 2019

Closing date: 29th November 2019

 

At UCB everything we do starts with a simple question: “How will this make a difference to the lives of people living with severe diseases?” We do that by connecting with patients and their families around the world living with the physical and social burdens of severe disease of the immune system and the central nervous system. Those connections offer new perspectives, drive innovation, and offer the hope of a new generation of therapies that will help to transform lives.

 

The Translational Biomarkers and Bioanalysis group is positioned within the function of Development Sciences, which as a department provides strategy and support in integrated pharmacokinetics/pharmacodynamics and DMPK, bioanalysis, immunogenicity, safety, pathology, and regulatory activities throughout the lifespan of projects, from target identification through to clinical studies. The Translational Biomarkers and Bioanalysis group operate and collaborate closely with colleagues in Development Sciences and across the organization to support bioanalysis and biomarker activities.

 

Role overview

Translational Biomarkers and Bioanalysis is looking for a high caliber, self-motivated, lab-based Biomarker Immunohistochemistry Scientist with a strong scientific background, good written and verbal communication skills and who can multi-task effectively and adapt to meet the demands of a fast-paced matrix-team environment.

 

The role is based in Slough, UK.

 

Primary responsibilities

  • You will employ your proven expertise to lead and drive the development of complex IHC/histology-based quantitative biomarker assays in the laboratory for measuring analytes in tissue samples and exploring diverse approaches to ensure delivery of high-quality fit-for-purpose assays.
  • Using in-house developed or commercially available IHC/histology approaches to measure the levels of biomarkers.
  • Assessment of novel biomarkers to ensure right dose, right molecule and right patient population within future clinical trials.
  • Where appropriate, characterize antibodies, conduct reagent evaluation and perform reagent qualification/tissue preparation optimization assessments.
  • Provide in-depth knowledge of IHC assay development and troubleshoot technical challenges.
  • Provide the appropriate levels of assay quality to ensure fit for purpose use.
  • Work within the Bioanalytical area to optimize experimental design, troubleshooting, sample analysis, data interpretation and report generation.
  • Develop the clinical IHC assay and support technical transfer to the CRO to ensure validation in the agreed timelines.
  • You will have in-depth knowledge to provide scientific and technical input to Project teams, Biomarker teams and Development Sciences teams.
  • Provide histology/IHC subject matter expertise for translational IHC and support the strategy and implementation of clinical IHC assessments.
  • Liaise with statistics and bioinformaticians to ensure optimum design of experiments.
  • Ensure compliance with all health and safety regulations.
  • Work within collaborations with external partners, academic institutions, CROs and consultants as required.
  • Maintain an awareness of new / emerging techniques and tools relevant to the field.
  • Represent and align with the objectives of Development Sciences internally and externally in matters relevant to biomarkers and bioanalysis.

 

Essential requirements

  • Candidates should have a minimum of BSc (or equivalent) in a biological discipline.
  • Proven hands-on direct expertise of pre-clinical and clinical histology, immunohistochemistry and in situ hybridization, including light microscopy & fluorescence microscopy, multiplexed formats, experience with image analysis software, data interpretation etc.
  • Knowledge of Halo, VisioPharm, Definiens, Volocity and related software.
  • Proven track record of developing novel fit for purpose IHC/histology-based biomarker assays from first principles for pre-clinical and clinical assessments.
  • Experience with the appropriate biomarker assay validation towards supporting clinical assessments and knowledge of the latest regulatory standards.
  • Clear grasp of context of use (linking assay requirements to the usage of the data generated).
  • A keen understanding of the impact of biological and assay variability for fit for purpose biomarker assay development and data interpretation and proven expertise in delivery.
  • Proven lab-based expertise in clinical IHC assay pre-validation and knowledge of clinical validation to support regulated studies.
  • Demonstrated ability to work independently in a dynamic laboratory environment to meet project timelines with minimal supervision.
  • An ability to work in a matrix and communicate clearly to colleagues and project scientists, able to discuss ideas, provide constructive challenge and useful feedback.
  • Adaptable to changing project and organizational priorities and consistently aligned with departmental needs.

 
Preferred experience

  • Previous experience of working in a pharmaceutical drug discovery and development environment.
  • Experience working with a wide range of internal stakeholders including Therapeutic Area, Non-Clinical Safety, DMPK, Translational Medicine, Clinical Pharmacologists, Pathologists, Biostatisticians, Clinical operations and Quality Assurance colleagues.
  • Established track record of working with Clinical Research Organizations in support of clinical IHC assessments.
  • Knowledge of the latest regulatory standards and industry best practices related to IHC diagnostics & kits, IHC biomarkers.
  • Experience of working with electronic lab notebooks.
  • Knowledge of statistical tools for the analysis of assays

 

We can offer you plenty of scope to influence the pipeline and make a difference to patients, with the potential to influence the strategy and drive the science.  UCB is a great place to get a breadth of experience of the drug pipeline, from research through to the clinic within a highly collaborative environment.  To learn, contribute and gain visibility in a scientific and cross functional setting. A competitive salary and benefits package.

 


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