LIMS Scientist I

Job Responsibilities

• Develop LIMS procedures for the laboratories and manufacturing, as needed; develop and maintain documentation for LIMS processes, user guides, and system validation.
• Maintain, configure, and troubleshoot the LIMS to support laboratory workflows and data integrity.
• Serve as the primary point of contact for LIMS-related issues in the laboratories and production, coordinating with IT and laboratory staff for timely resolution.
• Implement system updates, enhancements, and change controls in accordance with regulatory requirements (including, but not limited to, GxP, 21 CFR Part 11).
• Develop and Maintain the current studies and sample management protocols in the laboratory and continue to implement these protocols in LIMS per laboratory and quality requirements.
• Provide user training and support to laboratory personnel, ensuring effective and compliant use of the LIMS.
• Participate in audits and inspections, providing LIMS data and documentation as required.
• Collaborate with cross-functional teams to support new laboratory initiatives and system integrations.
• Ensure data security, user access management, and backup procedures are in place and effective.
• Support laboratory business continuity and disaster recovery planning as it relates to LIMS.
• Conduct hands-on training sessions (e.g., lunch-and-learns) to demonstrate system navigation, sample and test lookup, and day-to-day LIMS use for laboratory staff as needed.
• Solicit and synthesize user feedback across laboratory stakeholders (e.g., via surveys) to inform system configuration and improve usability and data integrity.
• Support review of process engineering decisions, including electronic signature and audit-trail/reason-for-change requirements, to ensure alignment with 21 CFR Part 11.
• Maintain working knowledge of the LIMS implementation roadmap and key project milestones to support planning, on-site vendor visits, and readiness activities.

Skills and Qualifications

• BS in Chemistry, Science, or relevant field with seven to ten years of experience in pharmaceutical or other cGMP experience.
• An advanced degree with less experience will be considered provided the LIMS experience requirement can be met.
• One to three years of experience with LIMS system, experience with Veeva LIMS strongly preferred.
• Experience with other modern LIMS systems preferred (i.e. Labware).
• Experience with injectable pharmaceuticals or radiopharmaceuticals is strongly preferred.
• Experience with HPLC, TLC, GC, Gamma Spec, and ICP preferred; or experience with microbiology lab equipment preferred.
• Experience with laboratory instruments in some form is required.
• Multi-disciplined scientist with GMP experience.
• Highly motivated and organized professional with the ability to work independently or in a team environment.
• Experience with root cause techniques such as 6 M's, 5 Why's, fishbone, or similar preferred.
• Very personable with strong communication skills.
• Excellent professional ethics, integrity, and ability to maintain confidential information.
• Must be comfortable working in a controlled environment with ionizing radiation and able to lift 40 lbs.
• Comfortable coordinating on-site vendor visits and cross-functional milestone reviews as part of a phased system implementation.
• Uses AI tools to enhance individual productivity and quality of work