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Our client is active in the pharmaceutical industry.
Manufacturing Scientist Senior
Description de la fonction
The Manufacturing Sciences Principal Scientist is a new position in the PS & MQ team, supporting the growth of the Manufacturing Sciences team and of the manufacturing site. As a Manufacturing Scientist, you will have the following responsibilities:
- Identify, support and drive innovative projects related to new or existing products, that will ensure process robustness and productivity.
- Uses QbD, DOE, pFMEA, Lean approaches, and implements new technologies (including PAT) where appropriate.
- Lead and support complex CAPA investigations related to manufacturing operations.
- Uses DMAIC/Six Sigma approaches, and advanced statistical tools.
- Ensure and defend adequate deployment, implementation and utilization of all quality systems as defined by the company's Procedures within his organization. Ensures a thorough and timely handling of associated tasks.
- Lead the Process Knowledge Management Strategy of the PS & MQ activities.
- Ensure up to date Process FMEA (pFMEA) for new or existing processes.
- Ensure regular literature and industry process knowledge review and share it with the team and the site to favor fast and efficient learning curve.
- Ensure appropriate documentation for regulatory filings, and defense during audits with health authorities (FDA, AFMPS, Japan, CBS,).
- You have a PhD degree in Pharmaceutical Sciences, Bio-Engineering or BioChemistry with 8+ years of experience or a master's degree in same discipline with 12+ years of experience or a bachelor's degree in same discipline with 14+ years of experience.
- You have minimum 5 years of experience in Pharmaceuticals & Bio-therapeutics manufacturing, including biologics drug development and industrialization, with deep understanding of both protein biochemistry and structural biology.
- You have a strong background in QbD, DIDOV, DOE, pFMEA, Lean, Six Sigma and DMAIC approaches; Green/Black belt certification is an asset.
- You have a relevant experience in preparation of regulatory submission files and defending topics during FDA or cGMP audits.
Our client offers you a challenging position in a dynamic team with an attractive salary package.
Are you interested? Do you want more information? Do not hesitate to contact me on 02 389 11 76 or via
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Encore 57 jours pour postuler
- Type de fonction : Scientifique
- Secteur : Chimie
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- Bachelor académique
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