Gene Therapy Molecular Biology Qc Testing
il y a 2 jours
**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?
To strengthen our new Gene Therapy (GT) CMC Analytics Department, based in Braine, Belgium we are looking for a talented individual to fill the position of: Gene Therapy Molecular Biology QC Testing (Associate) 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.
As a GT Molecular Biology QC Testing (Associate) Scientist, your main objectives are:
- To implement high throughput analytical tools supporting the release and stability of multiple therapeutic gene therapy programs throughout clinical phases (from phase 1 to readiness to launch).
- To support the development, validation, tech transfer (to internal or external partners) and execute fast and reliable assays to support the clinical development of AAV-based Gene Therapy Products in accordance with current rules and procedures (i.e. GMP/GSP).
- To support process development activities by executing reliable and QC friendly molecular biology methods.
You will contribute by:
- Supporting release and stability testing of Gene Therapy Products by developing, validating, coordinating, executing and/or tech transferring fast, reliable and QC friendly Molecular Biology assays. The position consists of a significant time spent at the bench (~80%)
- Contributing to analytical and process development, drive results.
- Cross-training and providing support for upstream/downstream process sciences, 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 (double check, data check).
- 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 and process sciences activities.
- Managing priorities and engage/communicate in a multidisciplinary environment. Support 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 molecular biology or equivalent preferred. Bachelor’s degree with sufficient experience could be considered.
- Hands-on experience in developing Molecular Biology method in a QC environment, regulated laboratory environment (e.g. GLP/GMP).
- In-depth understanding of analytical methods within the biopharmaceutical industry (i.e. viral vector quality control experience in industrial research or contract manufacturing setting).
- Ability to operate the following equipment/software is desired: Western Blots, ELISA, Gel Electrophoresis,
- Previous development or validation of methods for viral vector products is a plus.
- Deep understanding of characteristics to be considered for analytical method validation.
- Knowledge of statistical tools supporting the development/characterization of reliable analytical methods.
- Knowledge and understanding of regulatory requirements and of HSE/Biosafety/GMP-GLP-GSP rules
- Good command of English. French is a plus.
Soft skills:
- Ability to think critically and demonstrate troubleshooting and problem-solving skills.
- Well organized, flexible, meticulous and rigorous (data integrity oriented).
- Ability to integrate new concepts and to work in a multicultural environment and to work efficiently and independently in a changing environment.
- Interpersonal skills to communicate and maintain good working relationships within the team and with internal/external customers/partners.
- Team spirit oriented and able to offer/receive constructive feedbacks.
- Proven autonomy in the lab.
- In a project: ability to work under scientific and managerial guidance; to write and manage analytical documentation as well as to deliver results for
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