Quality Control Microbiology Laboratory Supervisor

Bristol Myers Squibb•Indianapolis, IN

1d•Onsite

About The Position

At RayzeBio, a wholly-owned subsidiary of Bristol Myers Squibb, the mission is to develop transformative radiopharmaceutical therapies for cancer patients. The company fosters a multidisciplinary team environment where ideas and expertise are valued. RayzeBio is seeking a Quality Control Microbiology Laboratory Supervisor to report to the Director- Microbiology Quality Control. This 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.

Requirements

Bachelor’s degree (BS) in Microbiology, Biology, or a related life science discipline required.
Minimum 5+ years of experience in a QC Microbiology or related laboratory within a cGMP‑regulated environment.
Demonstrated leadership and personnel management skills.
Strong knowledge of cGMP, USP <61>, <62>, <71>, <85>, EU GMP Annex 1, and data integrity principles.
Ability to investigate microbiological excursions and deviations using risk‑based approaches.
Excellent written and verbal communication skills.
Highly organized, detail‑oriented, and capable of managing multiple priorities in a fast‑paced environment.
Ability to work in classified cleanroom environments while wearing appropriate gowning.
Flexible schedule, including occasional weekend or off‑shift support based on business needs.

Nice To Haves

Advanced degree (MS) preferred.
Prior supervisory experience strongly preferred.
Experience supporting sterile manufacturing and/or radiopharmaceutical operations is highly desirable.

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.

Benefits

Additional incentive cash and stock opportunities (based on eligibility)
Health Coverage: Medical, pharmacy, dental, and vision care.
Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)
Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
Unlimited paid sick time (based on eligibility)
Up to 2 paid volunteer days per year (based on eligibility)
Summer hours flexibility (based on eligibility)
Leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs
Annual Global Shutdown between Christmas and New Years Day (for all global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year)