(Associate) Scientist CMC

argenx

Gent, Belgium

Purpose of the function

(Associate) Scientist CMC occupies a supporting role in Chemistry, Manufacturing and Controls (CMC) team for argenx therapeutic antibodies and their life cycle management following commercialization.

Reporting Line

Director CMC, analytical development

Roles and Responsabilities

Follow up on the execution of agreed commercial supply plan for outsourced QC testing in close collaboration with Global supply team; receival of external CoA and CoC’s, author the internal CoA’s for the bulk drug substance and drug product
Close follow up of actions for change controls, deviations, OOS investigations related to QC activities at external vendors in close collaboration with the DS and DP manufacturing and QA team; supports investigations for OOE/OOT release and stability results including root cause investigations and impact assessments on the process performance capabilities;
Close follow up on stock levels and distribution of critical reagents and reference standard inventories; follow up on shipments from the main stock to the working stocks at the different QC labs; support the activities to replenish critical reagents in due time and in accordance to the regulatory submissions. Follow up of the reference standard trending and stability programs; author retest date statements
Maintain the complete data repository of product quality via control charts of the analytical critical quality attributes, as part of process performance evaluation
Follow up on annual stability trending within the approved shelf-life;
Follow up on the analytical method life cycle, possible transfers, protocols and reports; and analytical method performance trending across the multiple QC testing sites
As a member of the CMC commercial team contribute to technical and strategic CMC discussions;

Skills and Competencies

Thorough knowledge and experience with GMP and in depth knowledge of ICH and GMP regulations;
Works independently within the scope of his/her assigned field and supports others;
Keep abreast with relevant scientific and/or technical developments;
Ability to go into detail whilst keeping the view on the overall project goal;
Strong technical expertise combined with good project management skills and ability to communicate effectively with internal and external stakeholders;
Flexible attitude, capable of picking up the tasks that require attention;
Quality conscious attitude;
Well organized;
Able to operate in a dynamic surrounding of a fast growing biotech company with challenging timelines;
Team player; able to build effective relationships with internal and external stakeholders

Education, Experience and Qualification

Master in chemistry, pharmaceutical sciences, bio‐engineering, or other discipline within pharmaceutical/biotechnology sciences;
Strong technical expertise in the field of biological drug substance and drug product manufacturing, process and product characterization, analytical method; development and validation; process validation and good understanding of statistics;
Fluent in English, written and spoken;

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