Job Title
Laboratory Systems Lead (hybrid)
This is an excellent position for anyone looking to join a leading multinational who excels in their field.
The Laboratory Systems Lead will support the implementation and configuration of Laboratory Systems. This role will assist laboratory teams in testing incoming raw materials, in-process drug substance/drug product, and stability samples.
1. SME on data management systems for instrument control in laboratories, including LIMS, Waters Empower, LabX, Softmax Pro, and other laboratory instrument controlling software.
2. Build lab IT systems to support tech transfer/commercialization and manufacturing of biologics. Monitor and support the performance of site laboratory systems according to cGMP and SDLC standards such as change control and document management.
3. Responsible for implementing industry best practices specific to laboratory systems processes that support sample management, testing, and validation.
4. Ensure site laboratory systems comply with changing requirements and trends in worldwide GMPs.
5. Deliver training to relevant personnel on correct application of site laboratory system procedures.
6. Pro-actively participate in processes to ensure laboratory systems continue to function effectively and improvement/remediation actions are taken such as Change Controls, Documentation Management, CAPAs, and Audit Readiness.
7. Continuous improvement of laboratory systems - identifying and building in efficiencies as necessary from a systematic and compliance perspective.
8. Provide SME support for general troubleshooting, problem-solving, technical direction, and guidance to support overall business needs.
9. Create an environment of 'right first time' in everything done through focus on principles of lean, including simplification, standard work, visual management, and a learning organization.
10. Responsible for timely updates of site achievements and challenges. Collaborative approach working cross-functionally on resolving obstacles to maintain highly effective and productive functional group.