Quality Control Supervisor

1 week ago

Indianapolis, Indiana, United States Bristol Myers Squibb Full time
Job Summary

Bristol Myers Squibb is seeking a highly motivated and organized Quality Control Supervisor to oversee quality control testing activities related to radiopharmaceuticals. The successful candidate will manage a team of QC chemists, ensure compliance with regulatory and QA system requirements, and maintain high standards of quality for radiopharmaceutical product release.

Key Responsibilities
  • Supervise and mentor a team of QC chemists to ensure timely completion of quality control activities.
  • Assign tasks and prioritize workload to ensure on-time and right-first-time release of drug product and isotopes.
  • Foster a positive and collaborative work environment within the lab and with external stakeholders.
  • Work with management and planning to schedule workflow and projects across the quality control team.
  • Participate in method transfer activities from CMO or internal research facility to the production and QC teams.
  • Identify opportunities for process improvements and implement changes to increase quality and efficiency within the quality control laboratories.
  • Release of product and other studies
  • Perform analyses of validated/verified methods to support novel RayzeBio radiopharmaceuticals, raw materials, and components.
  • Collaborate with manager and/or reviewer to ensure all documentation for release is reviewed.
  • Work with manager and/or investigation writer to ensure any discrepancies are resolved in a timely manner.
  • Quality Assurance/Regulatory Compliance
  • Assist in the routine calibration and maintenance of laboratory equipment.
  • Work with quality assurance and management to implement internal audits.
  • Participate in troubleshooting of issues and implement corrective actions to improve quality processes.
  • Develop and maintain appropriate documentation, particularly data analysis and team KPIs.
  • Work with RSO and QA to ensure compliance with GMP regulations, safety guidelines, and quality standards.
  • Assist in the reviewing of Standard Operating Procedures and other documents.
Requirements
  • BS in chemistry or related field with 9+ years of experience in the pharmaceutical field OR MS in chemistry or related field with 7+ years of experience in the pharmaceutical field.
  • Experience testing in a quality control chemistry lab.
  • Experience in radiopharmaceutical field and handling radioactive materials preferred.
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.
  • Ability to multi-task and prioritize work based on multiple workflows.
  • Good organizational skills required.
  • Work with multiple computer systems, including Microsoft Office, and chromatography systems.
  • Excellent professional ethics, integrity, and ability to maintain confidential information.
Work Environment

The noise level in the work environment is usually moderate.

This is a position that requires working in a laboratory environment, protective clothing, gloves, and safety glasses are required while working in a laboratory environment with radioactive materials.

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