The companyOur client is a professional Pharmaceutical, Biotechnology, Clinical Research and Healthcare organisation, based in Flandre Orientale Belgium. The company, a Belgian biopharmaceutical company active in the development of antibodies, patented therapeutic proteins based on single-chain antibody fragments.
The company is committed to developing new medicines that make a real difference to society.
Today the Company has around 45 programs in its own development and with partners in various therapeutic indications such as inflammation, hematology, immuno-oncology, oncology and respiratory diseases.
Role descriptionThe QC Lab of the Quality Department is looking for an (Associate) Scientist who manifests himself as project leader for the GMP QC Lab in Nanobody programs. The main responsibilities are release, stability and testing of preclinical, clinical and commercial instruments under full GMP control.
ResponsibilitiesYou carry out your activities in the GMP QC Lab according to the Quality System
You set the GMP QC Lab in cross-department teams and in external contacts as a matter expert
You are responsible for transferring the technology from one of the GMP units to an enabling unit
You are responsible for the development of GMP analysis methods (such as SEC, RPC, IEX-HPLC, cIEF, CGE, CE-IEF, UV spectrometry, compensation methods and potency determination (ELISA of cell-condition testing))
You are responsible for the preparation of the control systems in the GMP QC Lab
You perform method qualification and / or validation according to current GMP regulations, ICH guidelines and Pharmacopeia. You implement the lifecycle management method and monitor the methods that are carried out on different sites.
You carry out a technical assessment of the analysis results, assist and guide the (Senior) Research Associates in the technical solution of problems and carry out OOx studies if necessary
You track trending data and define appropriate transactions as required
You suggest and develop new approaches and processes
You organize training as a matter expert (including methods, laboratory systems)
You are responsible for the coordination, execution and quality control of the activities carried out by the GMP QC Lab. The planning is discussed and coordinated with the main QC and Engineering, the GMP QC lab, and the work is planned from day to day with the team of research staff for whom you are responsible.
You write, evaluate and complete the study plans and the final reports for the release tests, stability studies, method validation and all other studies that are carried out in the GMP laboratory.
RequirementsDoctorate in a relevant area of the life sciences of MSc, Bio-engineer with more than 7 years relevant experience
MS Office: competent level
Fluent in Dutch and English, written and spoken
You place technical expertise with people management
You have experience with physico-chemical analysis and / or potency testing of proteins
Experience with method validation, method life cycle management, critical reagent management, stability studies and release testing is an asset
Experience with GMP guidelines and a GMP working environment
Knowledge of ICH and Pharmacopeia
Team player, enthusiastic, independent and motivated
Excellent communication and writing skills are required
Sense of initiative, quality, accuracy and detail