Analytical Project Leader H/F

Festanstellung

Avenue Jules Bordet 168 1140 Bruxelles

25/02/2020

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Kennziffer der Stelle

2019-11539

Funktionsbereich

Operations — Engineering

Branche

Life sciences

Mindestanforderungen Ausbildungsniveau

Meister

Mindestanforderungen Erfahrungsniveau

5 bis 10 Jahre

Arbeitszeit

Vollzeit

Standort

Wallonisch-Brabant, Wallonia, Belgien

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Stellenbeschreibung

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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