Gene Therapy Quality Control Testing Scientist

il y a 22 heures


Brainel'Alleud, Belgique UCB Temps plein

**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 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 main objectives of the Gene Therapy (GT) Quality Control (QC) Testing Scientist 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**:
Gregory Parvizi as your Manager and many others talented colleagues at transversal level.

**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).

**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.
- 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.

genetherapy

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 with 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 patients, our employees, or our planet. Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential.

UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. We do not discriminate on the basis of race/color/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.



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