Gene Therapy QC Testing Scientist

Gene Therapy QC Testing Scientist

UCB - Union Chimique Belge

Braine L'alleud, Belgium

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.

Who you’ll work with:

You will collaborate with a dynamic and multidisciplinary team dedicated to analytical and process sciences in gene therapy, working independently and cross-functionally across various UCB teams.

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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