(Senior) Research Associate Analytics (CMC Ablynx GMP Unit) Job in Ghent, Belgium

(Senior) Research Associate Analytics (CMC Ablynx GMP Unit) Job Description

The GMP Unit of the of the CMC Department Ablynx (Chemistry Manufacturing and Control) is looking for (Senior) Research Associates that will be part of the team responsible for validation of methods, release testing, stability testing of Nanobody drug substance and drug product.

Responsibilities:

• You execute and control under full GMP control the analyses required for release testing, stability and in use testing for different Nanobody batches intended for pre-clinical and clinical use (GMP)
• You will regularly follow the planned GMP trainings.
• You validate various bio-physical methods such as, SDS-gel electrophoresis, normal and reversed phase chromatography (HPLC), UV spectroscopy, iso-electric focusing (cIEF), ELISA, cell based potency assays, pH, osmolality.
• You assist in drafting and finalizing the written working instructions and the method validation plans and assure technology transfer of analytical methods.
• You report the data according to the working instructions and compliant with GMP regulations
• You provide assistance in the receipt of goods and; you control that the storage of the materials is performed according to the internal guidelines and you assure that the shipment of materials from and to Ablynx is executed according to the specific instructions described.
• You are responsible for the qualification and calibration of certain pre-defined analytical equipment as well on the maintenance and calibration of pre-defined analytical equipment and general laboratory equipment (eg HPLC equipment, stability chambers,…..)
• You will plan your daily work independently according to the instructions given by your supervisor , (Scientist Study Manager). You perform the experimental work and prepare written reports of your results
• You supervise the daily maintenance of the laboratory supplies and the glass ware cleaning.

(Senior) Research Associate Analytics (CMC Ablynx GMP Unit) Job Requirements

Profile:

• Degree B. sc. Or M Sc (Industrial Engineer), Master in Biochemistry/ Biotechnology or equivalent with preferably 2 to 5 years experience in laboratory work
• Previous experience with working in a GMP environment is a plus
• Experience in physico-chemical analysis of proteins is an asset but not required
• Experience with cell culture technology is an asset but not required.
• Experience with common HPLC equipment is an asset
• Team player, enthusiastic, accurate in execution and reporting
• Excellent communication skills
• Sense for initiative, quality, accuracy and detail
• Knowledge of Dutch and good writing skills in English

(Senior) Research Associate Analytics (CMC Ablynx GMP Unit) Application Information

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(Senior) Research Associate Analytics (CMC Ablynx GMP Unit) Summary

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