Gene Therapy Bioassay Development Leader

工作内容

To strengthen the Analytical Development Team, based in our Gene Therapy CMC Development Department in Braine-l’Alleud, Belgium, we are looking to fill the position of: Gene Therapy Bioassay Development Leader.

This function will support the Adeno-Associated Virus (AAV) manufacturing processes and products with the aim of providing treatment to unmet medical needs through Gene Therapy (GT).

The Gene Therapy Bioassay Development Leader has the responsibility to manage all GT CMC bioassay development activities for GT projects in Braine throughout clinical phases (from phase 1 readiness to commercialization) and the lifecycle of the product.

This is a growth opportunity that combines the excitement and opportunity of a start-up with the security and institution knowledge gained from working for a larger company.

Major accountabilities:

• Support to Preclinical Development and Clinical Development Phases (from early phase to commercialization) by developing reliable potency assay matrix (e.g. infectivity assay, transgene expression assays (mRNA/protein), functional (mechanism of action specific) IN VITRO bioassays).
• Build a strong GT Bioassay Development Team.
• Manage the delivery of analytical methodologies, validation, stability studies, release of DS and DP and tech transfer of methods to QC and/or from/to CMOs/CROs according to business needs (e.g. quality and timelines).
• Ensure the provision of analytical troubleshooting expertise to internal/external (e.g. CMO/CRO) business partners (e.g. RA, QA, QC, IP).
• Actively contribute to regulatory submissions with internal/external (e.g. CMOs/CROs) business partners (e.g. RA, QA, QC, …)
• Foster state-of-the-art bioassay analytical skills set to meet and exceed industry standards with respect to science, quality standards and regulatory guidance.
• Support the business mission of UCB becoming a Gene Therapy Leader by innovating, implementing and, when appropriate, publishing innovative analytical methodologies.
• Influence and network beyond own team including externally (e.g. regulator through industry consortiums). Represent UCB in external working groups and in international conferences, as appropriate.
• Contribute to the systems management of environment and maintain ISO 140001 certification.

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

• D. in Molecular Biology, Cell Biology, Virology or equivalent.
• At least 5 years of relevant bioassay analytical development experience in a pharmaceutical company including at east 1 year of experience in viral biology/viral vector potency assay.
• Extensive knowledge of scientific principles relevant to the development of reliable potency assay matrix.
• Experience in a GMP regulated laboratory is required.
• Experience with preparation of development reports and standard operating procedures.
• Experience with statistical approaches for assay development/validation and data analysis for biological assays (i.e. USP1032/1033/1034; EP5.3).
• Very good command in English (both written and spoken).

Soft skills:

• Proven Project/People Management & Leadership
• Interpersonal skills to communicate and maintain good working relationships within the team and with internal/external customers/partners.
• Ability to manage and prioritize multiple programs/projects in matrix environment.
• Well organized, flexible, meticulous and rigorous (data integrity oriented).
• Ability to direct the activities of analytical scientists to solve problems pertaining to development activities.

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.

If you believe you are the perfect match to join us on our pioneering adventure, then we invite you to apply and tell us more about your profile and motivation.