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Scientist CSS

Location: 

Braine L'alleud, Walloon Brabant, Belgium

Job Function:  Production
Job ID:  64872

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

Description :

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

 

The primary goal of the function is to provide scientific expertise to contribute to management of the release and stability studies 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 activities of this function will be:

- Preparing/reviewing stability or comparability protocols,

- Analysing results

- Verifying data

- Validating results within LIMS system

- Preparing/reviewing stability or comparability reports

- Preparing/reviewing specifications and justifications of specifications

- Following deviations and incidents

- Presenting/discussing results in project team meetings,

- Liaising with other departments or external partners

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: master degree 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,

- basic knowledge of statistics applied to stability studies,

- 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,

- ability to author and review comprehensive and accurate protocols and reports in English,

- ability to work in a matrix and customer-oriented environment,

- understanding of regulatory requirements.

 


Job Segment: Chemistry, Biochemistry, Scientific, Biotech, Scientist, Science, Engineering

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