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 thereof.
In this Specialist role, you contribute to reliable assay performance, reduced biomaterial-related supply risk, and consistent, on-time product supply.
Key responsibilities
- Support the IRM program by collecting and structuring technical information for critical biomaterials, including current use, availability, criticality, qualification status, documentation gaps, replacement readiness, and supply continuity risks.
- Contribute to detailed risk identification and mitigation by compiling critical biomaterial and assay data, followed by defining, planning and monitoring of a mitigation roadmap with relevant stakeholders.
- IRM risk mitigation activities including for example, supporting in documentation gathering, protocol writing, data evaluation and report writing.
- Support characterization (e.g., biological, chromatographical) and qualification activities for new, replacement, or transferred biomaterial batches, including data generation & evaluation, and documentation of results.
- Support biomaterial transfers and routine replacements for inline QC bioassays.
- Contribute to continuous improvement by identifying opportunities to standardize procedures, improve documentation quality, reduce variability, and strengthen biomaterial robustness and supply continuity.
- Contribute to biomaterial lifecycle management by establishing realistic replacement timelines and minimum stock limits.
- Assist in biomaterial-related investigations and troubleshooting by compiling and analyzing historical and current assay data, identifying potential technical causes, and supporting implementation of corrective and preventive actions.