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Quality Control Consultant
Eingestellt von Harvey Nash BE
Gesuchte Skills: Support, Consultant
Projektbeschreibung
The function: Quality Control Consultant
The incumbent will be working in the Clinical Supply Support team, within the Analytical Sciences for Biologicals department, supporting the early phase development of new biological entities (NBE). Performing release and stability testing of NBE products to support the early phase (clinical phases I to III) NBE portfolio.
The profile :
Bachelor degree as a minimum in Biology, Biochemistry, Biotechnology or any equivalent training oriented on biological molecules. Previous experience of working in the pharmaceutical environment with knowledge of working to G.M.P standards in a QC laboratory.
Mission responsibilities:
Working with other technicians in organizing the release and stability analyses of the lab.
Following up on deviations, incidents and validation of the results within a LIMs system.
Participating in method tech transfers from different laboratories.
Participating in co-validation/verification of analytical methods for early phase molecules.
Specific professional/technical expertise and key skills required:
Knowledge of current analytical methods such as HPLC-size exclusion, peptide mapping, oligosaccharide profiling, CIEX, Electrophoresis-SDS-PAGE & IEF, ELISA's-HCP, Protein A & Activity/Binding ELISA's, qPCR DNA residuals and Pharmacopeias techniques.
3 to 5 years Experience in development and validation of methods for these analytical techniques
GMP knowledge is an asset as well as an experience in a biopharmaceutical company and experience with regulatory guidelines ICH, EP, USP & JP
Good knowledge of English (especially passive English : ability to read scientific documents)
Well organized, flexible, meticulous and rigorous, proactive, team spirit, technical expertise, ability to integrate new concepts and to work in a multicultural environment
The incumbent will be working in the Clinical Supply Support team, within the Analytical Sciences for Biologicals department, supporting the early phase development of new biological entities (NBE). Performing release and stability testing of NBE products to support the early phase (clinical phases I to III) NBE portfolio.
The profile :
Bachelor degree as a minimum in Biology, Biochemistry, Biotechnology or any equivalent training oriented on biological molecules. Previous experience of working in the pharmaceutical environment with knowledge of working to G.M.P standards in a QC laboratory.
Mission responsibilities:
Working with other technicians in organizing the release and stability analyses of the lab.
Following up on deviations, incidents and validation of the results within a LIMs system.
Participating in method tech transfers from different laboratories.
Participating in co-validation/verification of analytical methods for early phase molecules.
Specific professional/technical expertise and key skills required:
Knowledge of current analytical methods such as HPLC-size exclusion, peptide mapping, oligosaccharide profiling, CIEX, Electrophoresis-SDS-PAGE & IEF, ELISA's-HCP, Protein A & Activity/Binding ELISA's, qPCR DNA residuals and Pharmacopeias techniques.
3 to 5 years Experience in development and validation of methods for these analytical techniques
GMP knowledge is an asset as well as an experience in a biopharmaceutical company and experience with regulatory guidelines ICH, EP, USP & JP
Good knowledge of English (especially passive English : ability to read scientific documents)
Well organized, flexible, meticulous and rigorous, proactive, team spirit, technical expertise, ability to integrate new concepts and to work in a multicultural environment
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Organisation/Management, Sonstiges