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Technician CSS

Location: 

Braine L'alleud, Walloon Brabant, Belgium

Job Function:  Production
Job ID:  64868

Technician “Clinical Stability and Specifications” – Analytical Development Sciences for Biologicals

Description :

The Analytical Development Sciences for Biological department is recruiting a Technician in the "Clinical Stability and Specifications" team located in Braine L'Alleud.

 

The primary goal of the function is to perform release and stability testing of UCB New Biologicals Entities (NBE) as appropriate, according to the agreed quality standards and timelines. The team’s primary responsibility is to manage release and stability studies according to the required GMP and regulatory standards for UCB Biologicals from early clinical phases to phase III. The team is also involved in method transfers, co-validations, specification settings, reference standard management and preparation of regulatory submissions with internal or external business partners.

The main techniques used are HPLC/UPLC, gel/capillary electrophoresis, pharmacopeias and immunoassays.

 

The main activities of this function will be:

- Performing daily laboratory activities related to release and stability testing

- Analysing results

- Verifying data

- Working with other analysts in organizing the release and stability analyses of the laboratory

- Following up deviations and incidents

- Validating the results within a LIMS system.

- Participating to method transfers from different laboratories

- Participating in co-validation or verification of analytical methods.

- Supporting the scientists in the documentation related to the lab activities

 

 

All these activities will be performed in compliance with the GMP rules and with the regulatory requirements for each development phase of the products.

 

 

 

Profile:

- preferred: bachelor degree (or master) in biochemistry or in analytical chemistry,

- proven expertise preferably in a similar role in the biotech industry,

- proven expertise in analytical techniques applied to proteins such as chromatography or electrophoresis (gel, capillary), immunoassays, q-PCR or pharmacopeias,

- strong and proven laboratory laboratory skills

- good practical experience in at least one of the analytical techniques used in the laboratory,

- good knowledge of GMP standards in QC laboratory,

- interpersonal skills to communicate and maintain good working relationships within the team and with internal/external partners,

- good knowledge of English (ability to read scientific documents),

- well organized, flexible, meticulous and proactive

- able to work in a multicultural environment.

 


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