Assistant Project Manager Analytical Development (PCA)

Our client, a leading pharmaceutical organization, is looking for an Assistant Project Manager to provide scientific expertise in physico-chemical method development. The role focuses on managing analytical activities from early clinical phases through to commercialization within a cross-functional environment.

• Prepare and review GMP and GSP documentation including methods, protocols, and technical reports.
• Manage change controls, deviations, CAPAs, and risk assessments related to analytical activities.
• Support regulatory submissions by providing key analytical deliverables and responding to inquiries from health authorities.
• Review and evaluate analytical data generated by external partners to ensure quality and compliance.
• Liaise with departments such as QA, QC, and RA to ensure effective analytical knowledge transfer.
• Present scientific results and recommendations during project team meetings to support decision-making.

• Master's or PhD in Biochemistry, Analytical Chemistry, or a related scientific discipline.
• You have 3+ years of experience in the pharmaceutical industry within analytical development.
• You possess expertise in analytical method development and validation using techniques like liquid chromatography and capillary electrophoresis.
• You bring a strong knowledge of quality and regulatory standards including GMP, GLP, and change control systems.
• You're an expert in project management with the ability to manage multiple priorities and deliver against tight timelines.
• You have excellent communication and interpersonal skills, with experience working in matrix environments.
• You are fluent in English and French, both spoken and written.

Nice to Haves

• Proficiency with specialized QMS and document management systems.
• Advanced expertise in regulatory requirements for product development phases.

• Geniet van een competitief salarispakket met extra voordelen die je talent erkennen.
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