Analytical Project Leader H/F
Permanent contract
Avenue Jules Bordet 168 1140 Bruxelles
02/25/2020
Reference number
2019-11539
Category
Operations — Engineering/production
Business industry
Life sciences
Minimum level of education required
Engineering Degree
Minimum level of experience required
5 to 10 years
Contractual hours
Full time
Location
Walloon Brabant, Wallonia, Belgium
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Job 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).
Profile
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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