Position: LIMS Specialist
Onsite Position!
Work Schedule- M-F; Standard Hours!
100% Onsite
Work Schedule- Standard Hours; M-F
Top Skills-
BS 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 preferred
Background
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 Description:
Reporting 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 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).
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/EXPERIENCE/SKILLS
Education and Experience:
BS 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 preferred
Experience with HPLC, TLC, Gamma Spec, and ICP preferred. Experience with at least some laboratory instruments required
Skills:
Highly motivated and organized professional with the ability to work independently or in a team environment
Multi-disciplined scientist with GMP experience
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.
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