Gene Therapy Cell Based Assay Research

Conteúdo do emprego

The Translational Biomarkers and Bioanalysis (TBB) Department is positioned within the function of Development Sciences, a division which provides strategy and support to transition novel pharmacological assets, including gene therapy derived assets, from research into the clinic. TBB operate and collaborate closely across the organization to support bioanalysis and biomarker activities.

As part of the growth of UCBs gene therapy portfolio, the Translational Biomarkers and Bioanalysis group is looking for a highly skilled, experienced and self-motivated lab-based scientist to contribute to the development of cell-based transduction and neutralizing antibody assays to advance our gene therapy assets.

The ideal scientist will focus on developing assays to inform understanding on pre-existing and induced immune responses to gene therapy interventions based on extensive immunology knowledge and assay development expertise. The lab will work in a non-regulatory environment developing assays to support assets up to candidate selection and will work in close partnership with the relevant therapeutic area(s). The scientists will play a pivotal role in transfer of assays into the regulated environment.

The successful candidate will have a strong scientific background, good written and verbal communication skills and be able to multi-task effectively and adapt to meet the demands of a fast-paced matrix-team environment.

The role is based in Belgium in Braine l’Alleud.

Skills and experience:

Required

• Candidates should have a BSc and preferably a PhD in a biological discipline, ideally in Immunology
• Proven track record in developing assays to assess immunogenicity risk as well as contribute to scientific contributions to immunogenicity risk assessment
• Extensive and proven experience developing and validating cell-based assays to assess the impact of pre-existing antibodies and induced immune response
• Experienced working in BSLII laboratories and working with AAV gene therapy products
• Experience of working in a matrix to generate and disseminate key data
• In-depth technical understanding and experience across a wide array of assays to assess immune response including NAB assays and ELISPOT technology platforms.
• Experience in working in a way that minimizes risk of viral cross contamination from sample receipt to data generation.
• Capable of working too the highest quality standards required to support development, characterization and validations of cell-based assays effectively and delivery to key deadlines
• Proven track record of developing novel solutions in a discovery, and preferably a clinical setting
• Demonstrated ability to generate, analyse and present critical data sets in collaboration with statisticians and other colleagues
• Demonstrated ability to work effectively in a dynamic laboratory environment to project timelines
• 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.
• A keen understanding of the impact of biological and assay variability on experimental design and delivery
• Adaptable to changing project and organizational priorities and consistently aligned with departmental needs

Preferred

• Previous experience of working in a pharmaceutical drug discovery and development environment.
• Experience with molecular techniques such as qPCR or ddPCR.
• Understanding of regulatory agency expectations for immunogenicity assays to support gene therapy products, especially AAVs.
• An understanding of biomarkers would be a distinct advantage
• Good working knowledge of neuroscience, immunology and / or cancer biology
• Experience with the appropriate assay validation towards supporting clinical assessments and knowledge of the latest regulatory standards
• 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.
• Experience of working as a departmental representative in a project matrix
• The analysis of pharmacodynamic endpoints
• Clear grasp of context of use (linking assay requirements to the usage of the data generated) of biological data
• Knowledge of the latest regulatory standards and industry best practices

Role and Responsibilities:

• You will employ your proven expertise to lead the development and delivery of assays in support of the gene therapy pipeline with responsibility for transferring cell-based immunogenicity assays to CROs and thereby into the clinic
• Play a key part in delivering the strategy of the TBB team to ensure input into the gene therapy strategy
• Develop cell-based assays to characterize pre-existing and induced immunogenicity in a range of non-clinical and clinical sample types
• Work with key stakeholders to ensure prioritization and optimal deployment of technologies
• Work with CROs to transfer and deliver key assays to clinical deadlines
• Work with scientists in discovery and the therapeutic areas, as well as clinical scientists, to develop and implement novel assays
• Work within the Bioanalytical area to optimize experimental design, troubleshooting, sample analysis, data interpretation and report generation
• You will have in-depth knowledge to provide scientific and technical input to Project teams and Development Sciences teams
• Liaise with statistics to ensure optimum design of experiments
• Ensure compliance with all health and safety regulations
• Develop and grow links with key academic collaborators
• 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 to ensure the group remains state of the art
• Represent and align with the objectives of Development Sciences internally and externally in matters relevant to biomarkers and bioanalysis