Gene Therapy Physico-Chemical Method Development Scientist

Contenido de trabajo

To strengthen our new Gene Therapy Analytical Development Department, based in Braine, Belgium we are looking for a talented individual to fill the position of: Gene Therapy Physico-Chemical Method Development Scientist.

This function 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.

The two main objectives of the Gene Therapy (GT) Physico-Chemical Method Development (PCMD) Scientist are:

• To identify and to implement high throughout analytical tools supporting the release and stability of multiple therapeutic gene therapy programs throughout clinical phases (from phase 1 to readiness to launch).
• To develop, validate, transfer (to internal or external partners) and execute fast and reliable physico-chemical assays to support the clinical development of AAV-based Gene Therapy Products in accordance with current rules and procedures (i.e. GMP/GSP).

You will more precisely contribute by:

• Supporting release and stability testing of Gene Therapy Products by developing, validating, coordinating, executing and/or transferring fast, reliable and QC friendly physico-chemical assays.
• Contributing and potentially lead assay development, drive results.
• Cross-training and providing support for / operations, in- analysis, characterization and vector biology teams.
• Providing high quality documentation (procedures, protocols, reports) of all technical work performed in the lab in accordance with data integrity requirements.
• Verifying data.
• Participating to the result analysis and trending.
• Presenting/discussing results in team meetings.
• Preparing written procedures and instructions.
• Sustaining scientifically current (state of the art) laboratory environment and/or data systems.
• Working independently and cross functionally across various UCB teams related to analytical activities.
• Supporting the development of the UCB GT strategy internally as well as externally (i.e. CMOs/CROs).

All these activities 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.

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

• Master’s degree in Biochemistry or assimilated
• At least 2 to 4 years of experience in a regulated laboratory environment within the biopharmaceutical industry
• Proven expertise in physico-chemical method development with hands-on experience developing biophysical based methods for protein or impurity quantification.
• Knowledge of statistical tools supporting the development/characterization of reliable analytical methods.
• Ability to operate the following equipment/software is preferred: Capillary Electrophoresis, HPLC, UHPLC, LC-MS, dynamic and static light scattering,…Empower, Chromeleon, Electronic Lab Notebook,…
• Additional experience with nucleic acid based analytical methods for viral vectors is preferred.
• Previous experience in development or methods validation for viral vector products is a plus.
• Knowledge and understanding of regulatory requirements and of HSE/Biosafety/GxP rules.
• Very good command in English (and French), both spoken and written.

Soft skills:

• Ability to think critically and demonstrate troubleshooting and problem-solving skills.
• Well organized: ability to manage priorities and engage in a multidisciplinary environment.
• Meticulous and rigorous: data integrity oriented.
• Ability to adopt an efficient and independent way of working in a changing environment.
• Interpersonal skills to communicate and maintain good working relationships within a multicultural team and with internal/external customers/partners.
• Team spirit oriented and able to give/receive constructive feedbacks.
• Ability to work under scientific and managerial guidance: undertaking the writing of a set of procedures and analytical documentations, delivering results for interpretation.

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.