(Associate) Scientist CMC

Description du poste:

Purpose of the function

(Associate) Scientist CMC occupies a supporting role in Chemistry, Manufacturing and Controls (CMC) team for (COMPANY NAME) 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;