LIMS Administrator Specialist

Kedrion Biopharma Inc. is an international company that collects and fractionates blood plasma to produce and distribute plasma-derived therapeutic products for us in treating and preventing serious diseases, disorders and conditions such as Hemophilia, Primary Immune System Deficiencies and Rh-Sensitization.

Job Summary

At Kedrion Biopharma, every step of our manufacturing process contributes to therapies that improve and save lives for people with rare and serious conditions. As a LIMS Administrator Specialist , you'll be part of the team responsible for the configuration, maintenance, optimization and operational support of the LIMS system, ensuring full compliance with quality regulations and maximum efficiency of QC and QA laboratory processes. The role involves strong collaboration with both laboratory teams and corporate functions, for the validation of new functionalities, and the management of new flows and master data.

What you'll do

• Management and updating of master data (parameters, test methods, product specifications, sampling plans).

• Implementing new features and system updates in collaboration with vendors, IT, and corporate functions.

• Coordination with corporate functions for the validation of new functionalities, the management of new flows and the governance of master data.

• Management of interfaces between LIMS and other business systems (e.g. SAP).

• Support end users for the resolution of technical and operational problems.

• Development and updating of SOPs, user manuals and system documentation.

• Provision of specific training for laboratory and QA/QC personnel on the use of LIMS.

• Ensure system compliance with GMP, GxP and corporate data integrity policies.

• Participation in internal and external audits, providing evidence and required documentation.

• Management of system validation processes (URS, OQ, PQ).

• Analysis and continuous improvement of laboratory workflows through the automation and digitization of processes.

• Collaboration with lab managers and corporate functions to implement new features and optimize QC and QA activities.

• Support QC Laboratories functions as needed.

• May perform other duties as assigned.

• Specific training plan to be provided.

Qualifications and need-to-know

• Bachelor's Degree in scientific disciplines (Chemistry, Biology, Biotechnology or similar) or computer science.

• Skills in data integrity and cybersecurity applied to laboratory systems.

• At least 1 years' experience in the management of LIMS systems in the pharmaceutical or biotechnology field.

• Effective communication with internal teams, corporate functions and suppliers, even in complex or international contexts.

• Teamwork and collaboration, both at local and corporate level.

• Ability to actively listen to users and stakeholders.

• Priority management and organization.

• Flexibility and adaptability to process changes and new technologies.

• Orientation towards continuous improvement.

• Cross-functional leadership to drive cross-functional activities.

• Conflict management and mediation between different needs.

• Knowledge of QC and QA GMP flows, including the ability to map, optimize, and digitize processes according to current regulations.

• Knowledge of GMP/GxP regulations and QC/QA laboratory processes.

• Ability to configure, validate, and maintain LIMS systems (preferably LabWare or equivalent).

• Excellent skills in problem solving, project management and working in multidisciplinary teams.

• Good knowledge of the English language

• Occasional travel (up to 10%) is required, including overnight stays and international trips. This includes visits to Kedrion locations, regional meetings, and official company functions.

Employment eligibility verification will be required at the time of hire. This position does not offer visa sponsorship now or in the future.

Kedrion Biopharma Inc. is committed to providing equal employment opportunities to all employees and applicants. We prohibit discrimination and harassment based on race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. This policy applies to all employment terms, including recruitment, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

Please note that salary ranges are calculated based off levels of: relevant experience, education, and certifications.

Kedrion Biopharma Inc. offers numerous benefits to our qualifying employees, including:

• Medical, vision and dental insurance

• Life and AD&D insurance

• Paid holidays

• PTO accrual

• and much more!

Please let us know if you would like further details regarding the benefits that we offer to our qualifying employees, and we would be glad to provide you with our full benefits guide, as well as answering any questions you may have!

If you require assistance with your employment application or need reasonable accommodations to perform job duties, please contact our Talent Acquisition team at [email protected] .

Kedrion Biopharma Inc. participates in E-Verify and provides the federal government with Form I-9 information to confirm employment authorization. For more information, please contact the Department of Homeland Security.