Senior Scientist M/V/X

For one of our pharmaceutical partners we are looking for a Senior Scientist. In this position you will work both on site as remote.

Main Responsibilities

• Represent the GMP QC Lab in cross departmental teams and in external contacts as subject matter expert

• Be responsible for the technology transfer of analytical methods from the GMP Unit to a Receiving Unit

• 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

• 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

• 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

• Follow up on trending data and define appropriate actions if required

• Organize trainings as subject matter expert (on methods, laboratory systems)

• Be responsible for the coordination, execution and the quality control of the activities executed by the GMP QC Lab

• 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

• Write and follow-up all quality related documents such as change controls, deviations, ., + Comprendre : Indépendant - (B1)

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PhD with at least a first experience within the pharma industry or Master with 7-10 years of relevant experience

. 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

. MS Office: proficient level

. Fluent English, written and spoken, fluent in Dutch preferred

Competencies:

? You combine technical expertise with good people management skills

? Team player, enthusiastic, independent and self-motivated

? Excellent communication and writing skills are required

? Sense for initiative, quality, accuracy and detail

Jefferson Wells Life Sciences specializes in supporting pharma & biotech companies in their daily challenges. Hence our interest in experts like you to pass our team.? Let's look together at your first challenge with us!