Gene Therapy Qc Testing

il y a 7 heures

Brainel'Alleud, Belgique UCB S.A. Temps plein

**Make your mark for patients**

We are looking for a **Gene Therapy QC Testing (Associate) Scientist** who is **rigorous, autonomous and team oriented** to join us in our **Analytical Development** team, based in **Braine-l’Alleud**, **Belgium**

**About the role**

This role 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 GT QC Testing Scientist are:

- To implement high throughput analytical tools supporting the process development, 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 (_e._ GMP/GSP).

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.

**Who you’ll work with**:

- **
Grégory Parvizi** as your Manager and many others talented colleagues at transversal level.

**What you’ll do**:

- Contribute to analytical and process development, drive results.
- Support release and stability testing of Gene Therapy Products by validating, coordinating, executing and/or tech transferring fast, reliable and QC friendly Molecular Biology assays.
- Cross-train and provide support for upstream/downstream process sciences, characterization and vector biology teams.
- Provide high quality documentation (procedures, protocols, reports) of all technical work performed in the lab in accordance with data integrity requirements.
- Verify data (double check, data check).
- Participate to the result analysis and trending.
- Present/discuss results in team meetings.
- Prepare written procedures and instructions.
- Sustain scientifically current (state of the art) laboratory environment and/or data systems.
- Work independently and cross functionally across various UCB teams related to analytical and process sciences activities.
- Manage priorities and engage/communicate in a multidisciplinary environment. Support the development of the UCB GT strategy internally as well as externally (_e._ CMOs/CROs).

**I**nterested? 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.
- In-depth understanding of analytical methods within the biopharmaceutical industry (_e._ viral vector quality control experience in industrial research or contract manufacturing setting).
- A previous experience in a regulated laboratory environment (_g._ GLP/GMP).
- ** Hands-on experience in developing analytical methods in a QC environment**:

- Molecular Biology: ELISA, PCR (qPCR and ideally dPCR), Western Blots, Gel Electrophoresis,

**AND/OR**
- PCMD: HPLC, UHPLC, dynamic and static light scattering,
- 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 knowledge of English and ability to read, analyze, and interpret common scientific papers.

**Soft skills**:

- Ability to think critically and demonstrate troubleshooting and problem-solving skills.
- Well organized, flexible, meticulous and rigorous (data integrity oriented).
- Ability to adopt an efficient and independent way of working in a changing and multicultural 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.

Being autonomous in the lab.

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

**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.

**Why work for us?**
At UCB, we don’t just complete tasks, we create value. We aren’t afraid to push forward, collaborate, and innovate to make our mark for patients. We have a caring, supportive culture where everyone feels included, respected and has equitable opportunities to do their best work. We ‘go beyond’ to create value for our patients, and always with a human focus, whether that’s on our pati

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