GT ADA Method Developer Scientist

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Make your mark for patients.

We’re here because we want to build the future and transform patients’ lives for the better.

At UCB, our people are our experiences and achievements, our passion and drive. That’s why we’re looking for talented individuals with diverse backgrounds and experiences - not just the best and brightest, but those who care about making a meaningful difference in the lives of patients. We promote an environment of diversity, openness, and respect where people can make valuable contributions.

An exciting journey lies ahead. Will you join us in pushing the boundaries of what’s possible?

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.

To strengthen our Translational Biomarkers and Bioanalysis (TBB) team, we are looking for a talented individual to fill the position of GT ADA Method Developer Scientist,based in Braine-l’Alleud, Belgium.

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 operates and collaborates closely across the organization to support bioanalysis and biomarker activities.

As part of the growth of UCBs gene therapy portfolio, TBB are expanding capabilities across modalities including Gene Therapy. They are looking for a highly skilled, experienced, and self-motivated lab-based scientist to contribute to the development of immunogenicity assays in support of Pre-Clinical and Clinical Development. The scientist will play a pivotal role in transfer of assays into the regulated environment by working alongside other internal colleagues.

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.

Main Accountabilities

• You will employ your proven expertise to lead the development and delivery of fit for purpose Immunogenicity assays in support of UCBs pipeline (Novel biological entities, AAV based Gene Therapies)
• You will develop fit for purpose assays to measure humoral response from early stage preclinical to late-stage clinical phases
• You will liaise with the statistics team to ensure optimum design of experiments or data interpretation
• You will actively promote transfer of scientific knowledge amongst peers and keep abreast of latest developments in bioanalysis including critical development methodologies, new/emerging technologies, analysis tools and publications to ensure the group remains state of the art
• You will be in charge of validation and sample testing to support early-stage preclinical phase (Non-regulated studies) aligned with industry best practices
• You will collaborate with internal (regulated laboratory) or external stakeholders (CROs) to deliver and transfer key assays and provide expert advice in validation strategies
• You will troubleshoot these assays by resolving technical issues when required
• You will provide scientific and technical input to Project teams to establish BA strategy, define deadlines & prioritization, and provide data interpretation
• You will train and mentor other scientists when required
• You will ensure compliance with all health and safety regulations
• You will organize and prioritize your proper workload to meet project deliverables
  

Interested? For this position you’ll need the following education, experience and skills:

• Extensive experience and proven track record in developing and validating ADA ligand binding assays to assess immunogenicity (Humoral response) for Novel biological entities (Proteins, Antibodies, bi & tri specifics, AAV based gene therapy drugs) from early preclinical stage to late clinical stage
• In-depth knowledge of bioanalytical techniques and platforms (Direct assays, Bridging Assays, PandA assays, using ELISA/MSD platforms)
• Ability to troubleshoot immunoanalytical methods to ensure methods are fit for purpose
• Knowledge of the latest regulatory standards and industry best practices for validation of ADA assays to assess immunogenicity
• Capable of working to the highest quality standards required to support the development, characterization, and validations of assays effectively and delivery to key deadlines
• Demonstrated ability to generate, analyze and present critical data sets in collaboration with statisticians and other colleagues if required
• 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
• Adaptable to changing project and organizational priorities and consistently aligned with departmental needs
• Previous experience of working in a pharmaceutical drug discovery and development environment
• English: fluent, both oral and written. French will be considered a plus
  

Preferred

• Experience in developing and validating cell-based assays in support of immunogenicity
• Experience in developing and validating ligand binding assays in support of PK assessment for a novel biological entity
• Experience working with a wide range of internal stakeholders including Therapeutic Area, Non-Clinical Safety, Translational Medicine, Clinical Pharmacologists, Pathologists, Biostatisticians, Clinical operations, and Quality Assurance colleagues
• Clear grasp of context of use (linking assay requirements to the usage of the data generated) of biological data
• Previous experience of working with different technologies (Gyrolab & ELLA technologies) or different platforms (LC-MS, Automation)
  

We can offer you an informal and open working environment that does not lock scientists into structure and hierarchy. Freedom to take space to pursue your own ideas and make a difference. Opportunity to gain internal and external visibility through interactions with other UCB teams and with world-renown academic investigators. Opportunity to grow both as a drug hunter and leader through participation in project teams and our career/personal development programs.

Why you should apply

At UCB, we strive to attract passionate and outstanding talents who thrive on change and are ready to bring real value to patients. Working for us you’ll discover a place where you can grow and express your full potential. We place an emphasis on innovation, collaboration, and impact. Through meaningful recognition and a motivating work atmosphere, we aim to provide an optimal experience by caring about and valuing our employees – just as we do for the patients we serve.

About Us.

UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 7,600 people in all four corners of the globe, inspired by patients and driven by science.

At UCB, everything we do start with a simple question: “How will this create value for people living with severe disease?”. We are on a journey to become the patient-preferred biopharma leader by delivering medicines and solutions that improve lives. We want to ensure the creation of patient value, now and into the future, while contributing to a society where a population of 8 billion people and more should be able to live a good life within limited resources of one planet.

Curious to know more? Please visit our website www.ucb.com .

UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. We do not discriminate on the basis of race/color/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.