Specialist - Large Molecule Biocritical Reagents

Job Description

We are looking for a Specialist to join the ATS-Bio Technical Life Cycle Management Biomaterials team. The ATS-Bio Technical Life Cycle Management Biomaterials team supports the establishment and execution of harmonized lifecycle management for critical biomaterials used in LM QC assays.

Biomaterials are biological reagents playing a critical role in bioassays, which are produced in-house or purchased commercially, Due to their critical role in bioassays, biomaterials are considered critical assets and an Integrated Risk Management (IRM) program was initiated.

Main responsibilities for this Specialist role, will be to manage the Integrated Risk Management (IRM) program together with relevant QC sites, establishing a detailed risk overview per biomaterial, followed by additional in depth data evaluation of the QC test in which the biomaterial is used, and where needed, defining a roadmap to mitigate these risks and support in execution ...