Quality Control Microbiology Laboratory Supervisor

About the role

RayzeBio is a wholly-owned subsidiary of Bristol Myers Squibb, blending 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.

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. Ensure all laboratory testing is performed in accordance with approved SOPs, validated methods, and regulatory requirements.
• Maintain strict adherence to aseptic technique, gowning practices, and cleanroom behaviors during laboratory activities. Review, approve, and/or verify microbiological data, logbooks, and electronic records to ensure accuracy, completeness, and ALCOA+ data integrity principles.
• Maintain inspection-ready documentation and support internal audits, regulatory inspections, and third-party assessments. Ensure laboratory equipment, materials, and reagents are within calibration, qualification, and expiry prior to use.
• 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.
• 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.

Requirements

• 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.

Qualifications

• Demonstrated leadership and personnel management skills.
• Strong knowledge of cGMP, USP, , , , 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.

Skills & Competencies

• Leadership and personnel management skills.
• Knowledge of cGMP, USP, , , , EU GMP Annex 1, and data integrity principles.
• Investigation of microbiological excursions and deviations using risk-based approaches.
• Written and verbal communication skills.
• Organizational and detail-oriented abilities.
• Ability to work in cleanroom environments.
• Flexible schedule.

Benefits

RayzeBio offers a comprehensive benefits package including:

• 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.
• Work-life Benefits: Paid time off, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs, and an annual Global Shutdown between Christmas and New Years Day.

Pay

$107,904 - $130,754

Schedule

Full-time