Life at BMS
At RayzeBio, every day is an opportunity to ignite meaningful change. As a wholly-owned subsidiary of Bristol Myers Squibb, RayzeBio blends the nimble, pioneering spirit of an emergent biotech with the global expertise and resources of a leading innovator in oncology. Our mission is to develop transformative radiopharmaceutical therapies that offer new hope for patients living with cancer. Here, you’ll join a multidisciplinary team where your ideas are valued, your expertise is amplified, and collaboration is at the heart of everything we do. From day one, expect to make an immediate impact—on our science, on our teams, and most importantly, on patients. Learn more about RayzeBio: https://careers.bms.com/rayzebio/
Summary
RayzeBio is seeking a LIMS Specialist, reporting to the Associate Director of Quality Control. The position will be responsible for the continuing implementation and ongoing operation of the Veeva LIMS system in support of the laboratories at RayzeBio's Indianapolis manufacturing plant. The implementation consists of three phases, of which the first phase is complete. After all phases are complete, the LIMS Sr. Associate Scientist will be responsible for continued operation of the system.
The position will be on-site; located at RayzeBio's manufacturing plant, in Indianapolis, IN.
Job Responsibilities
Essential duties and responsibilities include the following. Other duties may be assigned.
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…