Gene Therapy Bioassay

il y a 4 semaines


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

**Make your mark for patients**

We are looking for a **Gene Therapy Bioassay (Associate) Scientist** who is **flexible,** **team and solutions oriented** to join us in our **Gene Therapy Process and Analytical Sciences **team, based in Braine-l’Alleud, **Belgium**

**About the role**

The primary purposes of the Gene Therapy Bioassay (Associate) Scientist are:
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**:

- ** Fabian Borghese **as your manager as well as many other colleagues at transversal level.

**What you’ll do**:

- Develop and execute fast, reliable, and QC-friendly cell-based potency assays under mínimal scientific guidance to support release and stability testing of AAV-based Gene Therapy products.
- Perform phase-appropriate assay validation in accordance with international regulatory guidelines.
- Tech transfer assays from/to external partners when needed.
- Provide analytical support to upstream/downstream process development and vector biology teams.
- Deliver high quality documentation (procedures, protocols, reports) in accordance with data integrity requirements.
- Actively contribute to data verification (double-check), data interpretation, and communication (through reporting and attendance to meetings/congresses).
- Build and maintain strong knowledge of challenges and advance associated to potency assay development in the Gene Therapy landscape.
- Maintain state-of-the-art laboratory environment and data systems.
- Manage priorities and engage/communicate in a multidisciplinary environment.
- Work independently under scientific and managerial guidance and cross functionally across various UCB teams (pre-clinical development, process development, analytical development, regulatory, QC, QA).

**I**nterested? For this role we’re looking for the following** **education, experience** **and **skills**
- Phd or master’s degree.
- At least 2 years of experience in a regulated laboratory (GLP/GMP).
- Demonstrated expertise in Analytical Development (experimental design, execution, data interpretation, and troubleshooting) and validation.
- Strong hands-on experience in Cell Culture, ELISA, dPCR (or qPCR). Experience in flow cytometry is a plus.
- Working knowledge of viral biology is preferred.
- Knowledge of statistical tools supporting the development/characterization of reliable analytical methods.
- Knowledge and understanding of regulatory requirements and of HSE/Biosafety/GMP-GSP rules.
- Ability to work independently under mínimal scientific supervision. Full lab autonomy is required.
- Full professional proficiency in English.

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 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.

**Learn more** about sustainability at UCB and how it is integrated into our business approach.

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/colour/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.


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