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Bristol Myers Squibb

Makes drugs for cancer, blood and immune diseases

LIMS Scientist 1

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeIndianapolis, IN, USA

About the Job

Requirements

  • A Bachelor of Science in Chemistry, Science, or a relevant field, with seven to ten years of pharmaceutical or other current Good Manufacturing Practice experience; an advanced degree with less experience may be considered if the LIMS experience requirement is met.
  • One to three years of experience with a Laboratory Information Management System; experience with Veeva LIMS is strongly preferred, and experience with other modern LIMS systems such as LabWare is preferred.
  • Experience with laboratory instruments is required.
  • Be comfortable working in a controlled environment with ionizing radiation and able to lift 40 pounds.
  • Be comfortable coordinating on-site vendor visits and cross-functional milestone reviews as part of a phased system implementation.
  • Use artificial intelligence tools to enhance individual productivity and quality of work.

Responsibilities

  • Develop LIMS procedures for laboratories and manufacturing as needed, and 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 laboratories and production, coordinating with information technology and laboratory staff for timely resolution.
  • Implement system updates, enhancements, and change controls in accordance with regulatory requirements, including Good Practice (GxP) and 21 CFR Part 11.
  • Develop and maintain current studies and sample management protocols in the laboratory, and continue implementing these protocols in LIMS in line with laboratory and quality requirements.
  • Provide user training and support to laboratory personnel to ensure effective and compliant LIMS use.
  • 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, such as lunch-and-learns, demonstrating 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, including through 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.

Desired Qualifications

  • Experience with injectable pharmaceuticals or radiopharmaceuticals is strongly preferred.
  • Experience with high-performance liquid chromatography, thin-layer chromatography, gas chromatography, gamma spectroscopy, and inductively coupled plasma, or experience with microbiology laboratory equipment, is preferred.
  • Experience with root cause techniques such as the 6 Ms, 5 Whys, fishbone analysis, or similar methods is preferred.

About the Company

Bristol Myers Squibb

Makes drugs for cancer, blood and immune diseases

Bristol Myers Squibb discovers, develops and sells prescription medicines for serious illnesses, including cancer, blood disorders, immune diseases and heart disease, for patients treated by doctors and hospitals around the world. Its best-known drug is Opdivo, an immunotherapy that helps the body's own immune system find and attack many kinds of cancer. Researchers develop drug candidates in its labs or bring them in through acquisitions and partnerships, then test them in clinical trials to win regulatory approval. The company makes and markets the approved medicines and earns its revenue from sales of patent-protected drugs. Its roots go back to a business founded in 1887, and it is based in Lawrence Township, New Jersey.

Company size
10,001+
Company stage
IPO
Headquarters
Lawrence Township, NJ
Founded
1887

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