IMP Supply Manager

AgomAb Therapeutics

Vaste jobs

Onbepaalde duur

Voltijds

Dagwerk

Gepubliceerd op 12/11/2025

Functieomschrijving

What will you do?

You will develop, implement and manage an IMP Supply Planthat is in alignment withthe overall Project plan and Clinical study timelines. The IMP supply plan will be developed in collaboration with the Clinical study team and the CMC team
You will select and manage Clinical Supply vendors and keep oversight of their activities
You will make proposals for suitable kit design based on the clinical study design and create Master labels;
You will forecast the demand of the different IMPs and non-IMPs for the clinical development programs both initially and on an ongoing basis throughout the clinical development program
You will contribute to RTSM set up by advising on site and depot supply and resupply parameters;
You will ensure that the Product Specification File for the IMP supply activities is kept up to date;
You will ensure IMP supply source documents for clinical trial applications aretimely available
You will ensure that all work is conducted in accordance with applicable policies and procedures, cGMP and regulatory standards & guidelines

You have a bachelor or Master in Sciencesor other relevant areas with proven subject matter expertise in IMP supplywith at least 10 years of working experience
You have experience in working in an outsourced model with external vendors
You have good understanding of drug development, clinical trials management and related supply, quality and regulatory requirements.
You have computer literacy in MS officeapplications as well as the ability to generate presentations;
You are comfortable with electronic records & digital workflows;
You are capable of working well independently under minimal supervision as well as in a team;
You are flexible and able to multitask, prioritize, meet deadlines in a fast-paced environment;
You are an open-mindedindividual with interpersonal abilities;
You speak and write English fluently;
You are willing to travel occasionally.

Engels
Nederlands
Wetenschappelijke, technologische, technische, reglementaire, … informatie opvolgen en actualiseren
Verschillende diensten en klanten technisch bijstaan
Oplossingen en technische en technologische evoluties ontwikkelen De kenmerken en eisen van het project bestuderen
De methodes en middelen voor studies en ontwerp en hun uitvoering bepalen
Technische dossiers voor de beschrijving van het project opstellen en aanpassen
De uitvoerbaarheid van het project bestuderen Technische en technologische voorstellen uitwerken

Doelen en prioriteiten bepalen en aangeven hoe ze te bereiken.
Ontleden van een probleem en aanvullende informatie zoeken.
Algemeen aanvaarde normen volgen.
Aandacht hebben voor kwaliteit en fouten voorkomen.
Doelgericht handelen.
Meningen en hun gevolgen tegen elkaar afwegen aan de hand van relevante criteria.

The opportunity to develop pioneering science in a young biotech company;
Challenging and innovative work environment as part of a driven team;
Flexibility and responsibility with remote working options that can be tailored for you;
Competitive salary and benefits;
An agile and fast paced environment.

Via e-mail

Via telefoon

+32 3 302 35 30