Analytical Project Leader H/F

CDI

Avenue Jules Bordet 168 1140 Bruxelles

25/02/2020

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Référence

2019-11539

Catégorie

Operations — Engineering/production

Secteur Industriel

Life sciences

Niveau d'études minimum requis

Bac +5 / Ingénieur

Niveau d'expérience

5 à 10 ans

Temps de travail

Temps plein

Localisation

Brabant wallon, Wallonie, Belgique

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Description

What about the project and the main tasks ?

·     Defining integrated solutions & plans in the analytical field (e.g. release & testing strategy) for designated chemical development product(s), starting from Phase I to first commercial approval;

·     Implementing those solutions & plans through projects leadership;

·     Collaborating with Analytical Product Owner to support lifecycle management;

·     Taking accountability of key analytical deliverables of the corresponding drug substances and drug products (e.g. methods, specifications, stability and regulatory submissions) to support the Pharma Sciences and Technical Operations network and ensure supply continuity for patients;

·     Anticipating needs in the analytical field to mitigate risks and create competitive advantages for your product(s).

Profil

What about your profile ?

·     Master's Degree (required) with PhD in Analytical Sciences ;

·     Expert in the analytical testing field with a strong experience on CMC development strategy for NCE (starting from Phase I to commercial readiness);

·     Project leadership skills including planning, monitoring, issue resolution, risk mitigation, decision making and reporting;

·     Experience in GMP, Regulatory Affairs and Quality applied to analytical ;

·     Ability to lead and influence people in a matrix environment;

·     Change management skills with a strong sense of accountability & responsibility.

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Notre Politique d’embauche participe à améliorer la représentation de la diversité au sein des effectifs du Groupe AKKA. Nos recrutements sont donc ouverts à tous les candidats dont le profil correspond aux caractéristiques et exigences du poste, en dehors de toute autre considération que les qualités et compétences professionnelles.