Operations — Engineering/production
Niveau d'études minimum requis
Bac +5 / Ingénieur
5 à 10 ans
Temps de travail
Brabant wallon, Wallonie, Belgique
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).
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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OPERATIONS — ENGINEERING/PRODUCTION