Analytical Project Leader H/F

Permanent contract

Avenue Jules Bordet 168 1140 Bruxelles

02/25/2020

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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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