The GMP QC Lab of the Quality Department is looking for a Senior Scientist who acts as project lead for the GMP QC Lab in a commercial Nanobody program. The main responsibilities are release and stability testing of commercial products and providing technical assistance during technology transfer and global expansion activities under full GMP control.

Main responsibilities

• You perform your activities in the Ablynx GMP QC Lab according to the Ablynx and Sanofi Quality System
• You represent the GMP QC Lab in cross departmental teams and in external contacts as subject matter expert
• You are responsible for the technology transfer of analytical methods from the Ablynx GMP Unit to a Receiving Unit
• You perform method validation according to current GMP regulations, ICH guidelines and Pharmacopeia. You perform method life cycle management and keep oversight over methods performed on different sites
• You assist in global expansion of a commercial product and you adapt the analytical methods based on gap assessments to the requirements of local authorities while still maintaining the validated status of the analytical method.
• You perform technical review of analytical results (such as SEC, RPC, IEX-HPLC, CGE, UV spectrometry, compendial methods, and potency assays (Biacore), assist and guide the Associate Scientist in technical problem solving and conduct OOx-investigations if required
• You follow up on trending data and define appropriate actions if required
• You organize trainings as subject matter expert (on methods, laboratory systems)
• You are responsible for the coordination, execution and the quality control of the activities executed by the GMP QC Lab
• You write, review and finalize the study plans and the final reports for the release testing, stability studies, method validation and any other studies performed in the GMP laboratory
• You write and follow-up all quality related documents such as change controls, deviations, …

About you :

• PhD with minimum 3 years of relevant experience or MSc, Bio-engineer, PharmD or equivalent with 7 to 10 years of relevant experience
• MS Office: proficient level
• Fluent in Dutch and English, written and spoken
• You combine technical expertise with good people management skills
• You have experience in physico-chemical analysis and/or potency testing of proteins
• Experience with technology transfer, method life cycle management, stability studies and release testing in a commercial setting is an asset
• Experience with GMP guidelines and a GMP working environment
• Knowledge of ICH and Pharmacopeia
• Team player, enthusiastic, independent and self-motivated
• Excellent communication and writing skills are required
• Sense for initiative, quality, accuracy and detail

Please make sure your attached CV contains a paragraph containing your technical expertise

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