Quality Control Microbiology Laboratory Supervisor

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/

Job Description:

RayzeBio is seeking a Quality Control Microbiology Laboratory Supervisor, reporting to the Director- Microbiology Quality Control.  The position will provide oversight for the daily microbiology activities supporting the GMP manufacturing operations related to radiopharmaceuticals. The supervisor will ensure data trending are executed in compliance with regulations, and company quality standards, troubleshooting efforts, ensuring compliance with regulatory and QA system requirements, and maintaining high standards of quality for radioisotopes and radiopharmaceutical product release.  The Supervisor will collaborate with the Radiation Safety Officer (RSO) to ensure laboratory compliance with the radiation safety program at the Indianapolis site. The position will require the applicant to work with and around ionizing radiation and hazardous chemicals.

The position will be located at RayzeBio’s manufacturing plant, in Indianapolis, IN.

Job Responsibilities:

Supervise daily QC Microbiology activities including, but not limited to:

• • Sterility testing

  • Bioburden testing

  • Endotoxin testing

  • Media qualification and growth promotion testing

  • Environmental Monitoring (viable air, surface, and personnel)

• Perform microbiology laboratory assays when needed.

·         Maintain strict adherence to aseptic technique, gowning practices, and cleanroom behaviors during laboratory activities.

• Ensure all laboratory testing is performed in accordance with approved SOPs, validated methods, and regulatory requirements.

• Review, approve, and/or verify microbiological data, logbooks, and electronic records to ensure accuracy, completeness, and ALCOA+ data integrity principles.

• Ensure laboratory equipment, materials, and reagents are within calibration, qualification, and expiry prior to use.

• Maintain inspection‑ready documentation and support internal audits, regulatory inspections, and third‑party assessments.

• Supervise, coach, and mentor QC Microbiology analysts and/or technicians.

• Assign and prioritize workload to ensure testing is completed “on‑time and right‑first‑time.”

• Conduct performance feedback, support skill development, and assist with onboarding and qualification of new hires.

• Ensure personnel are properly trained and qualified on methods, SOPs, aseptic techniques, gowning, and safety requirements, including participation in Train‑the‑Trainer activities where applicable.

• Partner with Manufacturing, QA, Facilities, Engineering, MS&T, and Radiation Safety to support production, facility readiness, and product release.

• Identify opportunities for process improvement, automation, and efficiency within the QC Microbiology laboratory.

• Support method lifecycle activities, equipment qualification, and technology improvements as needed.

Education and Experience

• Bachelor’s degree (BS) in Microbiology, Biology, or a related life science discipline required.

• Advanced degree (MS) preferred.

• Minimum 5+ years of experience in a QC Microbiology or related laboratory within a cGMP‑regulated environment.

• Prior supervisory experience strongly preferred.

• Experience supporting sterile manufacturing and/or radiopharmaceutical operations is highly desirable.

• Strong working knowledge of microbiological methods, EM programs, and regulatory expectations.

Skills & Competencies

• Demonstrated leadership and personnel management skills.

• Strong knowledge of cGMP, USP <61>, <62>, <71>, <85>, EU GMP Annex 1, and data integrity principl