Quality Control Manager Bio Test Method and Project Validations
il y a 2 semaines
Ceva Biovac is looking for its Quality Control Manager Bio Test Method and Project validations M/F for a permanent position based on the Beaucouzé Campus, 5 minutes from Angers (49).
- Job description/introduction:
Reporting to the Director of Quality and Regulatory Affairs and the CAMPUS within the Quality department, you will be responsible for managing the team in charge of bioassays on new technology vaccines (RNA type), validating or transferring analytical methods for QC and managing QC laboratory projects.
You will be responsible for
- Management of bio test (microplate RNA assay, SpectraDrop assay, capillary electrophoresis determination, PCR, RT PCR, SDS Page, ELISA, etc.),...
- Management of ‘bio’ physicochemical analyses (bio-inerte HPLC assays, densitometry, etc.), etc.
- Rereading of analytical files before signature by the CoA.
- Analytical transfers and validations in-house, with other Ceva sites or CROs,
- Projects (cell test implementation, DNA vaccine control project, etc.), LIMS, etc.
- Drafting protocols and reports for method transfers/validations.
You will work in collaboration with the Campus routine QC.
**Your profile**:
**Education/training**:
Master's degree in Biological or Chemical Analysis of Medicinal Products. You have experience of working in a pharmaceutical environment and are keen to take an interest in new technologies and bioassays.
**Technical skills / know-how**:
- Fluency in English (spoken and written)
- Mastery of biological techniques and knowledge of HPLC
- Mastery of analytical transfer/validation methods
- Ability to manage projects and a small team
- Behavioural skills / interpersonal skills
- You are organised, rigorous and autonomous;
- You enjoy multi-skilling and organisations on a human scale;
- You're committed to your work, you're a team player and you're keen to learn new technologies.
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