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Walloon BrabantHybrid40 hours/week<3months
You will support the implementation of Biologics-based products from Phase III throughout the product life cycle within a pharmaceutical company. Working closely with the QC Biologics management team, Team Leaders, and technicians, you will provide critical scientific expertise and ensure smooth laboratory operations.
What you will do.
- Manage end-to-end sample tracking (release, in-process, stability) through GMP systems, from reception to destruction.
- Handle deviations, investigations, corrective/preventive actions (CAPAs), and change controls.
- Ensure smooth internal communication regarding urgencies and priorities, adjusting planning with Team Leads and various stakeholders.
- Actively participate in meetings with Production and MSAT teams to ensure close coordination with the lab.
- Update and review laboratory documentation, including analytical methods, instructions, and coaching modules.
- Support product launches, new process implementations, and prepare necessary documentation for authorities (data sharing, batch updates, sampling plans).
Profile
- Education: Master's degree in Analytical Chemistry (applied to biological products / NBE), Biochemistry (CBA, PCR, Elisa, etc.), Biology, or equivalent.
- Experience: Minimum 5 years in a similar position with expertise in the pharmaceutical analysis of biological products, specifically monoclonal antibodies.
- GMP Knowledge: Proven experience working in a QC GMP environment is mandatory.
- Hard Skills: Strong track record in documentation creation/updating, planning, monitoring, and conducting investigations in collaboration with QA.
- Soft Skills: Excellent organizational and leadership skills, stress resistance, a continuous improvement mindset, and a problem-solving approach.
- Languages: Fluent in both English and French.
How to apply
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