The Company
The client is part of the global pharmaceutical company. The facility is focused on the development and manufacturing of biologic medicines, particularly in the fields of immunology, oncology, and infectious diseases. They specialize in producing large-scale biologic drugs, which are typically made from living cells and are used to treat complex diseases.
Role Description
We are seeking an experienced LIMS Specialist to support the deployment, optimization, and ongoing maintenance of digital laboratory solutions within the Advanced Therapies Quality Control (QC) organization. Based in Leiden, the successful candidate will act as the key expert for paperless laboratory implementation, partnering closely with local method SMEs and cross-functional teams to transform paper-based laboratory processes into standardized digital workflows. This position plays a critical role in driving digitalization initiatives, ensuring alignment with global standards, supporting system harmonization across sites, and enabling efficient execution of laboratory methods within the LIMS environment.Responsibilities
- Lead the conversion of paper-based laboratory methods into standardized digital workflows and execution templates.
- Drive harmonization initiatives to ensure consistency of laboratory methods and processes across multiple sites.
- Develop, maintain, and update method execution templates within the LIMS platform.
- Support change control activities, including impact assessments related to digital method implementation and updates.
- Contribute to the design, configuration, and management of master data used within digital laboratory systems.
- Coordinate master data verification and validation activities to ensure data integrity and compliance.
- Prepare, update, and maintain technical documentation in accordance with established standardization and harmonization processes.
- Manage enhancements, revisions, and lifecycle maintenance of existing digital laboratory methods.
- Provide training and guidance to laboratory personnel on newly deployed digital methods and processes.
- Serve as the primary point of contact for laboratory users regarding paperless lab processes, troubleshooting, and system-related questions.
- Support the setup, integration, and validation of laboratory instruments with the LIMS environment.
- Collaborate with stakeholders to identify opportunities for process improvement and increased operational efficiency.
- Bachelor's degree in Life Sciences, Chemical Sciences, Biotechnology, or a related scientific discipline.
- Advanced degree (Master's or PhD) is preferred.
- Minimum of 5 years of relevant experience within Quality Control, Quality Assurance, Analytical Testing, Laboratory Informatics, or Information Technology.
- Previous experience within the pharmaceutical, biotechnology, cell & gene therapy, advanced therapies, or another highly regulated industry.
- Hands-on experience with Laboratory Information Management Systems (LIMS), preferably LabVantage.
- Experience as a Key User, Super User, Business Administrator, or Subject Matter Expert for digital laboratory systems is highly desirable.
- Familiarity with laboratory testing methodologies and workflows is advantageous.
- Experience with instrument-to-LIMS integration and interface validation is considered a strong plus.
- Demonstrated involvement in process improvement, digital transformation, or laboratory automation projects.
- Strong understanding of regulated laboratory environments and GxP requirements.
- Excellent stakeholder management and cross-functional collaboration skills.
- Strong analytical and problem-solving capabilities.
- Effective communication, presentation, and training skills.
- Detail-oriented with the ability to manage multiple priorities in a fast-paced environment.
- Ability to translate business and laboratory requirements into practical digital solutions.
Apply to our vacancy for more information. Looking forward to getting in touch!
59032
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Marianna Tomkova
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