Gene Therapy Laboratory Leader

le contenu du travail

UCB is a leading global pharmaceutical company, dedicated to the research, development and commercialization of innovative pharmaceutical and biotechnology products in the areas of Neuroscience, Immunology and Oncology. The organization employs some 9000 individuals across approximately 40 countries. UCB is a pharmaceutical company with a size which enables it to deliver a significant drug pipeline, whilst remaining agile and innovative. For our talented scientists there is plenty of scope to influence the pipeline and make a difference to patients and great potential to influence the strategy and drive the science. UCB remains a great opportunity for the individual to get a breadth of experience of the drug pipeline from research through to the clinic, whilst working in a highly collaborative environment to learn, contribute and gain visibility in a scientific and cross-functional setting.

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.

We are looking for a dynamic technical leader to drive bioanalytical technology strategy to support UCBs portfolio with a focus on Gene Therapy. The ideal candidate will be a highly motivated self-starter with extensive experience in developing bioanalytical assays across multiple technology platforms in preclinical and early clinical development. The ideal candidate will have a proven track record leading scientific and technical teams in development and validation of analytical methods. You will also contribute to the technical transfer of assays to external partner laboratories ensuring efficient transfer of assays capable of meeting regulatory standards.

The successful candidate will have extensive experience, 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
• Proven track record as a scientific leader responsible for talent development
• Ability to lead a successful team in a dynamic laboratory ensuring delivery of high-quality, key analytical methods, according to project timelines.
• Extensive and proven experience of working in the area of Bioanalysis for Gene Therapy or Biologics.
• Clear practical expertise in the development of fit-for-purpose analytical methods.
• In depth knowledge of regulatory expectations of bioanalytical assays and extensive knowledge in the validation requirements of such assays that can stand up to scrutiny by regulatory authorities
• Demonstrate multi-tasking and adaptability to changing project and organizational priorities, consistently aligning with departmental needs
• An ability to work in a matrix, disseminate key data and communicate clearly to stakeholders, colleagues and project scientists, discussing ideas, provide constructive challenge and useful feedback
• 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
• A keen understanding of the impact of biological and assay variability on experimental design and delivery

Preferred

• Experience with AAV-based gene therapy projects and bioanalysis.
• Experience with molecular biology applications such as qPCR, ddPCR, transcriptomics.
• Experience with cell-based assays such as Cellular Transduction Inhibition, ELISPOT.
• Effective ability to progress assets from Research into Clinical Development
• Previous experience of working in a pharmaceutical drug discovery and assay development environment.
• Demonstrating knowledge of the latest regulatory standards and industry best practices.
• An understanding of biomarkers would be a distinct advantage
• Experience working with a wide range of internal stakeholders including Therapeutic Area, Non-Clinical Safety, DMPK, Translational Medicine, Clinical Pharmacologists, Clinical operations and Quality Assurance colleagues.
• Established track record of working with Clinical Research Organizations in support of method development and validation.
• Good working knowledge of neuroscience, immunology and / or cancer biology
• Experience of working as a departmental representative in a project matrix
• Clear grasp of context of use (linking assay requirements to the usage of the data generated) of biological data

Role and Responsibilities:

• You will employ your proven expertise to lead a successful laboratory driving the development and delivery of advanced bioanalytical solutions supporting the implementation of cell-based immunogenicity and genomic PK assessments in support of our Gene Therapy pipeline.
• Provide technical advice and guide the development and characterisation of bioanalytical assays for gene therapy assets.
• Play a key part in delivering the strategy of the TBB team to ensure and input into the gene therapy strategy
• You will act as subject matter expert, supporting project teams on bioanalytical considerations, and employ your expertise for the development of complex assessments to ensure delivery of high-quality fit-for-purpose assays in a non-regulated environment
• Develop qPCR assays for measuring pharmacokinetics in a range of non-clinical and clinical sample types
• Develop cell-based immunoassays to measure immunogenicity in a range of non-clinical and clinical sample types.
• Work with key stakeholders to ensure prioritization and optimal deployment of technologies
• Represent and align with the objectives of Development Sciences internally and externally in matters relevant to biomarkers and bioanalysis
• Provide in-depth knowledge of assay development and troubleshoot technical challenges across multiple platforms
• Work within the Bioanalytical area to optimize experimental design, troubleshooting, sample analysis, data interpretation and report generation
• Provide technical expertise on transfer of assays, both internally and to external partners.
• Work with CROs and other external providers to transfer and deliver key assays to project and study deadlines
• You will have in-depth knowledge of bioanalytical tools to provide scientific and technical input to Project teams, Biomarker teams and Development Sciences teams
• Ensure compliance with all health and safety, HTA, other regulations
• Maintain an awareness of new / emerging techniques and tools relevant to the field to ensure the group remains state of the art.
• Work with scientists in discovery and the therapeutic areas as well the clinical scientists to develop and implement novel assays
• 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.