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Associate Scientist PCMD

Location: 

Braine L'alleud, Walloon Brabant, Belgium

Job Function:  Production
Job ID:  64886

Associate Scientist “Physico-Chemical Methods Development for Biotech Products” – Analytical Development Sciences for Biologicals

Description :

The Analytical Development Sciences for Biological department is recruiting an Associate Scientist in the "Physico-Chemical Method Development" team located in Braine L'Alleud.

 

The primary goal of the function is to provide scientific expertise to contribute to manage physico-chemical analytical method development activities for UCB New Biologicals Entities (NBE) from early clinical phases to commercial. The team has primary responsibility for development of robust, fit for purpose and efficient methods, for validation of those methods to the required regulatory standards and for their transfer to internal or external partners. The group also provides analytical support and expertise to process understanding and process validation of UCB biological processes and is responsible for transferring methodology, technology, data and preparing regulatory submissions with business partners.

 

The key techniques used are HPLC/UPLC applied to proteins, electrophoresis (gel/capillary) and immunoassays (for process related impurities).

 

The main activities of this function will be:

- design experiments,

- supervise and perform daily laboratory activities related to analytical method development, validation, transfers, support to process,

- provide expertise to troubleshoot analytical issues on the techniques/methods run in the laboratory,

- analyse results,

- verify data,

- prepare and review documentation (procedures, protocols, reports as appropriate),

- present/discuss results in project team meetings,

- liaise with other departments or external partners to ensure analytical knowledge transfer.

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 (or bachelor degree with significant expertise),

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

- proven expertise in at least one of the above-mentioned key techniques.

- Practical knowledge in one or several of the following techniques is a major advantage:

  • the use of iCE (imaged capillary electrophoresis),
  • capillary electrophoresis or 2D gel electrophoresis applied to proteins
  • charge aerosol detector coupled to UPLC,
  • glycan or peptide mapping with UV or MS detector.

- proven expertise in method development and validation,

- strong knowledge of protein chemistry,

- strong and proven laboratory skills,

- high level of autonomy in the day to day work related to analytical method development / validation,

- ability to troubleshoot analytical methods/techniques in his/her domain of expertise,

- 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 procedures, protocols and reports in English,

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

- understanding of regulatory requirements and of GMP.

 


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