Senior Scientist, Stability LIMS Systems

About the Company:

Innopharma Technical Services, part of Innopharma Group, specializes in the training and provision of highly skilled, project ready, Contract Engineers & Scientists to the (Bio) Pharmaceutical and MedTech Manufacturing Sector.

We are now seeking a Senior Scientist – Stability LIMS Systems – to provide support integration of Global Stability operations into Laboratory Information Management System (LIMS) for our client site based in Dublin.

About the position:

This role supports the integration of Commercial Global Stability operations into a future-state Laboratory Information Management System (LIMS). The position will require direct interaction with LIMS business owners, partners, users and IT lifecycle management teams. On occasion, this role may be asked to perform stability scientist duties to support ongoing operations and protocol activities during the transition from multiple legacy systems.
The role requires deep expertise in stability programs, LIMS platforms (particularly LabVantage and LabWare), and cross-functional collaboration to ensure successful implementation, process alignment, and operational continuity.

Reports to – Senior Manager, Stability LIMS Systems.

Key Responsibilities:

• Support the Senior Manager in identification, documenting, and driving commercial stability user requirements for a future state LIMS system.
• Serve as a point of contact for the stability user group in order to liase with business and process owners and direct management, with the intent on developing, managing, and executing stability strategies related to the future and current state LIMS systems.
• Serve as a technical expert within the Sample Manager LIMS and Labware systems in order to support mapping multiple current state LIMS processes to a singular future state, centralized LIMS system.
• Support static builds, migrations, and system updates to enhance current stability operations for critical ongoing Run-the-Business requirements.
• Support and or manage user ticket requests to ensure available stability support and completion.
• Execute and/or manage completion of UAT for functionality changes.
• Training stability personnel on LIMS system usage.
• General LIMS user support and initial/basic troubleshooting.
• Maintain and operate within cGMP requirements, including maintaining training status.
• Perform stability scientist duties, as needed – stability submission and program strategies, stability protocols, trending, managing product requirements.

Preferred Experience:

• Minimum of Bachelor of Science, with at least 10 years of experience within the pharmaceutical industry
• At least 5 years of stability product/program experience and 5 years developing and executing LIMS strategies to support the stability program
• Must be able to understand stability process, quality, and integrated validated systems, in context of multiple LIMS systems
• Experience in processing LIMS tickets, demands, and enhancements requiring successful UATs
• Experience working across departmental and functional lines.
• Must be able to work across border, cultures and multiple time zones
• Must be able to operate within a global organization that encompasses different drug product platforms, multiple operational sites, and multiple LIMS systems and platforms
• Strong understanding of GMP requirements.
• Familiarity with Data Integrity principles is a requirement.
• Familiarity with Quality Risk Management is a benefit.
• Fluency with the French language is a bonus.

Note:

• Due to the nature of the role, additional related duties may be assigned.
• All applicants must be eligible to work in Ireland with Valid Visa.

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If you’re passionate about manufacturing excellence and eager to grow in a fast-paced, regulated environment, we want to hear from you.

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