LIMS Specialist

RayzeBio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals.Job DescriptionReporting to the Sr. Manager of Quality Control, LIMS Specialist will be responsible for ensuring the laboratories at RayzeBio?s Indianapolis implementation and operation of Veeva LIMS system into RayzeBio?s Indianapolis manufacturing plant.Job ResponsibilitiesDevelop 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).Set up studies and sample management 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.Education And ExperienceBS in Chemistry, Science, or relevant field with three to five 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 strongly preferredExperience with HPLC, TLC, GC, Gamma Spec, and ICP preferred. Experience with at least some laboratory instruments requiredSkillsHighly motivated and organized professional with the ability to work independently or in a team environmentMulti-disciplined scientist with GMP experienceExperience with root cause techniques such as 6 M?s, 5 why fishbone is, or similar preferredVery personable with strong communication skillsExcellent professional ethics, integrity, and ability to maintain confidential informationMust be comfortable working in a controlled environment with ionizing radiation and able to lift 40 lbs.Working Conditions: N/ATravel required: N/APhysical Demands: N/AOnsite Position!Work Schedule- M-F; Standard HoursThis posting is for a contract assignment with ASK Staffing DBA ASK Consulting to provide services to Bristol Myer-Squibb.The starting hourly compensation for this assignment is the following range ($66- $69.34/hr). While the final, individual compensation and any available benefits will be determined by your employer of record ASK Staffing, Inc (and not BMS), factors that will be included in making the final determination may include the characteristics of the assignment, such as demonstrated experience, required skill, and the geographic location where the job is performed. The starting hourly compensation may be subject to change.About ASK ConsultingASK Consulting is an award-winning, woman-owned staffing and recruitment solutions provider with over three decades of industry experience. We specialize in connecting businesses of all sizes?across IT, healthcare, engineering, finance, and more?with top-tier professionals. 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