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.
- 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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