MAKE YOUR MARK FOR PATIENTS

We are looking for a Gene Therapy Quality Control Testing Scientist who is rigorous, autonomous and team oriented to join us in our Gene Therapy Analytical Sciences team, based in Braine-l’Alleud, Belgium

ABOUT US

UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 8,500 people in all four corners of the globe, inspired by patients and driven by science.

ABOUT THE ROLE

You will support the development of recombinant Adeno-Associated Virus (rAAV) manufacturing processes and products with the aim of providing treatment to unmet medical needs through gene therapy.

Your main objectives are:

• To perform fast and reliable in-process analytical experiments for AAV-based Gene Therapy Products in collaboration with Process development teams.
• To contribute to analytical method validation and tech transfer (to internal or external partners).
• To implement and verify compendial assays for release and stability of multiple therapeutic gene therapy programs throughout clinical phases (from phase 1 to readiness to launch).

All these activities will support the clinical development of AAV-based Gene Therapy Products and will be performed in respect of the material and premises, in compliance with the HSE/Biosafety/GSP or GMP rules and with the regulatory requirements for each development phase of the product.

WHAT YOU’LL DO:

• Perform a wide range of assays for in-process analytics supporting Process development studies in accordance with data integrity requirements.
• Ensure a smooth and efficient implementation of fast, reliable and QC friendly assays from Analytical Development Teams.
• Cross-train and provide support for upstream/downstream process sciences, method development, formulation, Drug Product and Drug Device teams.
• Provide critical input to maintain high quality level of documentation (procedures, protocols, reports, results)
• Participate to troubleshooting efforts through results presentation and scientific discussions in team meetings
• Improve analytical method by providing feedbacks to method development teams.
• Establish and sustain scientifically current (state of the art) laboratory environment, data systems and equipments.
• Manage changing priorities and engage/communicate in a multidisciplinary environment. Support the development of the UCB GT strategy internally as well as externally (e. CMOs/CROs).

INTERESTED? FOR THIS ROLE WE’RE LOOKING FOR THE FOLLOWING EDUCATION, EXPERIENCE AND SKILLS

• Master’s degree preferred. Bachelor’s degree with sufficient experience could be considered.
• A previous experience in a regulated laboratory environment (g. GLP/GMP).
• Hands-on experience and good understanding of analytical methods in a Biopharma Quality Control environment (qPCR/ddPCR, ELISA; HPLC is a plus,…). Experience with viral vectors is a plus.
• Ability to author and review comprehensive GMP and GSP documents in English.
• Ability to think critically and adopt an efficient and independent way of working in a changing environment.
• Interpersonal skills to communicate and maintain good working relationships within the team and with internal/external customers/partners.
• Fluent level of English spoken and written is required.
  

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Are you ready to ‘go beyond’ to create value and make your mark for patients? If this sounds like you, then we would love to hear from you!