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 youll 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 impacton our science on our teams and most importantly on patients. Learn more about RayzeBio: 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 RayzeBios 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 inspectionready documentation and support internal audits regulatory inspections and thirdparty assessments.

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

• Assign and prioritize workload to ensure testing is completed ontime and rightfirsttime.

• 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 TraintheTrainer 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

• Bachelors 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 cGMPregulated 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 principles.

• Ability to investigate microbiological excursions and deviations using riskbased approaches.

• Excellent written and verbal communication skills.

• Highly organized detailoriented and capable of managing multiple priorities in a fastpaced environment.

• Ability to work in classified cleanroom environments while wearing appropriate gowning.

• Flexible schedule including occasional weekend or offshift support based on business needs.

• Uses AI tools to enhance individual productivity and quality of work

#LI-Onsite

If you come across a role that intrigues you but doesnt perfectly line up with your resume we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job such as required skills where the job is performed the employees work schedule job-related knowledge and experience. Final individual compensation will be decided based on demonstrated experience.

Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits please visit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:

• 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 include:

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

Based on eligibility* additional time off for employees may include unlimited paid sick time up to 2 paid volunteer days per year 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.

All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

*Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours depending on the nature of their work and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors leased workers and other service providers are not eligible to participate in the program.

RayzeBio and Bristol Myers Squibb

RayzeBio was acquired by Bristol Myers Squibb (BMS) in 2024 and is a wholly-owned subsidiary of BMS; however RayzeBio will continue to operate as a standalone organization.

Supporting People with Disabilities

BMS and RayzeBio are dedicated to ensuring that people with disabilities can excel through a transparent recruitment process reasonable workplaceaccommodations/adjustmentsand ongoing support in their roles. Applicants can request a reasonable workplaceaccommodation/adjustmentprior to accepting a job offer. If you require reasonableaccommodations/adjustmentsin completing this application or in any part of the recruitment process direct your inquiries to. Visit access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS and RayzeBio will consider for employment qualified applicants with arrest and conviction records pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position please visit this page for important additional information: Protection

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